Icon Group Annual Research Report 2022

ANNUAL RESEARCH REPORT 2022

ICON GROUP CHIEF EXECUTIVE OFFICER FOREWORD

I’m pleased to present Icon Group’s Annual Research Report, which showcases our commitment to advancing cancer treatment and technology through our global clinical trials program.

With a growing global reach, Icon delivers Australia’s largest private cancer clinical trials program, bringing together more than 35 years’ experience and dedication, across medical oncology, haematology, and radiation oncology, as well as unique Icon Investigator Initiated Trials.

As a leading integrated cancer care provider, we’re acutely aware of the devastating impact of cancer on patients, their families, and communities around the world. Our Icon team’s mission is to bring the best care possible, to as many people as possible, as close to home as possible.

With expected increases in cancer cases, we’re committed to investing in research and continuing to be at the forefront of new and emerging treatments that benefit patients and communities and help reduce the global cancer burden. 2022 was another milestone year for Icon towards achieving our mission. We entered our next phase of growth with our new majority investors, EQT, a purpose-driven, Europeanbased global investor who share the same values and ambitions to deliver the best possible care to more people.

Through this shared commitment, we set a fiveyear global strategy for Icon to sustainably grow in existing and new geographies, drive future healthcare and deliver operational excellence for our patients, customers, and people. This strategy will once again see Icon turn the dial in private clinical trials and care.

In 2022, our research team and network of doctors demonstrated they have the knowledge, experience, and motivation to lead the way forward in oncology research and beyond. Together, the team recruited record numbers of patients to our clinical trials, continual growth across our Australia network and a stellar first year for our Singapore research team.

I would like to particularly acknowledge our out-going Director of Research, Dr John Bashford and one of our founding doctors, A/Prof Dusan Kotasek who both announced their well-deserved retirement. As an Icon founding doctor, John has been a driving force behind the evolution of private oncology practice and enabled us to lead the way in private clinical research. Similarly, Dusan is a pioneer of oncology and through his long and respected career, he has helped lead and evolve South Australia’s healthcare and clinical trials landscape. Thank you, John and Dusan for your leadership and commitment to care. Please read their tributes in this report to learn more about their incredible careers and the impact they have made to so many people.

Our research offering will continue to thrive under new directorship and a proven model that will see us reach more people and help deliver innovative therapies to improve the lives and outcomes of patients worldwide. I look forward to this time next year to again share how Icon is expanding the boundaries of what’s possible and changing lives one day at a time.

MARK MIDDLETON OAM Icon Group Chief Executive Officer

IN 2022, OUR RESEARCH TEAM AND NETWORK OF DOCTORS DEMONSTRATED THEY HAVE THE KNOWLEDGE, EXPERIENCE, AND MOTIVATION TO LEAD THE WAY FORWARD IN ONCOLOGY RESEARCH AND BEYOND.”

EXECUTIVE MANAGERRESEARCH FOREWORD

2022 welcomed further evolutions in our research direction and cemented the future of Icon’s extremely well-established clinical trials program. I’m really proud of what we’ve achieved together and how we’ve continued to deliver on our mission through the following key areas - expanding our Australian footprint, focussing on our Investigator Initiated Trials (IITs) and technical research, and growing our newly established Singapore portfolio.

Icon Cancer Centre Hobart had an incredible year under the local leadership of A/Prof Louise Nott. The team hit the ground running activating 20 trials across Phase II and III with 20 patients recruited. The introduction of trials at our Hobart centre has already made a difference to local cancer patients, providing them more access to local trials which previously required travel to Victoria. Similarly, our two Icon Gold Coast sites experienced a stellar year with the continued growth of radiation therapy trials and a passionate group of Principal Investigators keen to activate more IITs this year and beyond.

Last year highlighted our ability to deliver a robust clinical trials program across geographies while also innovating with a focus on IITs, within oncology, and exploring how radiation therapy can potentially benefit other diseases. Alongside our IIT growth we continued to deliver a strong Phase I program and support our longstanding medical oncology and haematology portfolio.

2022 also saw the opening of the Slade Health Drug Stability Testing and Research Laboratory, the firstof-its-kind in Australia which has and will no doubt significantly increase our capacity to contribute to advances in cancer care. Our pharmacy and compounding capability complements our technical research which has significant future potential. We’re extremely fortunate to have an incredible team of

radiation therapists and medical physicists driving forward our research capabilities in this space, and alongside our five-year research agreement with Varian I’m confident this is only the start of what we can achieve together.

In its first year of delivering a dedicated research program, our Singapore team has made incredible progress. Under the leadership of Dr Hsieh Wen-Son and Director of Clinical Trials (ASEAN and Hong Kong), Joanne Chio, the team has launched new trials across medical oncology, including Icon’s first paediatric oncology trial, and signed several industry MOUs (Memorandums of Understanding) further extending our capabilities and reach across the ASEAN region.

The Singapore team’s achievements are an example of Icon’s ability to sustainably scale and grow within existing and new geographies and our future aspirations reflect our commitment to closing the care gaps in underserved communities. Through a focus on new geographies, molecular medicine and Real World Data, Icon is taking the next steps in research and broadening our capabilities to meet future cancer rates and lead evolutions in cancer care.

I would like to echo Mark’s sentiments and well wishes to Dr John Bashford and A/Prof Dusan Kotasek. John and Dusan are two incredible examples of exceptional clinicians. They both have an unwavering determination to advocate for clinical trials, increased collaboration, and improvements in patient care. Their knowledge, counsel and spirit will be sorely missed.

I would like to thank my senior leadership team, every member of research, our research partners, doctors, and investigators for championing clinical trials and going above and beyond to improve our services and how we care for our patients.

Executive Manager -

SOPHIE MEPHAM PHD

Research

THROUGH A FOCUS ON NEW GEOGRAPHIES, MOLECULAR MEDICINE AND REAL WORLD DATA, ICON IS TAKING THE NEXT STEPS IN RESEARCH.”

Mark and Sophie have outlined the great ongoing work of research at Icon and the bright future ahead. It is the essence of Icon’s commitment to provide exceptional patient care underpinned by investment in clinical trials. Our leadership in the care of our patients today and into the future comes from that commitment.

Last year we officially welcomed A/Prof Jonathan Ramsay as Co-Director of Research (Radiation Medicine). As one of the founders of Icon Group and a highly respected Radiation Oncologist with a passion for research, Jonathan has been instrumental in the strategic vision and direction of our radiation oncology trials. Under the newly named Radiation Medicine banner, Jonathan will also lead our molecular medicine strategy with a strong focus on theranostics and precision medicine, areas essential to future healthcare.

Looking forward it is now a time of leadership renewal with the retirement of both myself and A/ Prof Dusan Kotasek, one of the founders of Ashford Cancer Care Research (ACCR). Dusan established a private oncology clinical trials group in South Australia in 1997 and pioneered a successful framework and research model that would attract research partners and leading clinicians. The acquisition of ACCR in 2021 was an obvious alignment of our goals increasing our Phase I and overall research capacity. Dusan has been a visionary leader and his contribution to clinical research has been immense. I have been privileged to count him as a friend and colleague.

Announcing my own retirement was always going to be a difficult decision. Looking back at the achievements of 2022 and over the past 35 years, the milestones our team have achieved have been immense ranging from early adoption of many revolutionary treatments to the firm establishment of research as a basis for quality private medical practice. Obvious now in 2023 this was seen as an eccentric exception in 1990. I thank the many wonderful team members in this journey but particularly thank the really exceptional leadership team led by Sophie Mepham. I have absolute confidence in their ability to define a great future.

With a new generation of dedicated clinicians and an immensely capable global research team, research at Icon will continue to be the basis for best practice. As I move on to the next phase of my life and dedicate time to family, friends, and favourite causes I want to express my sincere gratitude to everyone who has been part of my career and particularly to my clinical and research colleagues. You have been a ‘true compass’ over the many years.

Thank you also to the Board and Executive of Icon for their strong belief and support of an endeavour that I’ve always regarded as the ‘invisible dividend’ on a balance sheet but a strong driver of overall success.

As always, my special thanks go to clinical trial patients and their families. Without their bravery, courage and support we cannot continue to advance cancer treatments and create a brighter future for all. It has been a true privilege to assist you in your very individual and challenging journeys.

DR

BASHFORD FRACP, FRCPA,

Co-Director of Research

JOHN

MAICD

WITH A NEW GENERATION OF DEDICATED DOCTORS, AND AN INCREDIBLY CAPABLE GLOBAL RESEARCH TEAM, RESEARCH AT ICON WILL CONTINUE TO BE A STRENGTH AND A FOCUS.”

OUR MISSION

Icon Group’s mission is to deliver the best care possible, to as many people as possible, as close to home as possible. We deliver world-leading integrated health care while working to address the global cancer burden.

Patient focused and doctor led, Icon provides personalised care, including choice of clinician, treatment, and timing, supplying lifesaving products, offering the latest treatment and technologies, investing in clinical research and innovation, striving to improve cancer care and outcomes for patients and communities.

Our full spectrum of cancer care includes haematology, medical oncology, radiation oncology, chemotherapy compounding, pharmacy management and clinical research.

Across our international network, Icon saw over three million patient interactions and will continue to increase our reach to ensure more people have access to the best possible care.

DELIVER THE BEST CARE POSSIBLE, TO AS MANY PEOPLE AS POSSIBLE, AS CLOSE TO HOME AS POSSIBLE.”

OUR VISION FOR RESEARCH

Icon’s research team is essential to the evolution of healthcare, continuing to innovate and disrupt the way we manage and treat cancer. We aim to provide more patients with care opportunities previously not available to them by bringing tomorrow’s treatments closer to today.

With more than 35 years’ experience, research is part of Icon’s DNA. Our commitment is backed by international

industry partnerships, investment in dedicated research teams and clinical leadership from highly respected researchers and specialists.

Icon’s international network of clinicians believe clinical trials are critical to the provision of exceptional cancer care and continue to confidently lead the way in operating Australia’s largest private cancer clinical trials program, with global growth opportunities.

Across Australia, New Zealand and Asia, Icon is dedicated to delivering the best care possible, to as many people as possible, as close to home as possible.

OVER 50 CANCER CENTRES GLOBALLY

730 360+

PATIENTS ACTIVE ON CLINICAL TRIALS

PATIENTS RECRUITED TO CLINICAL TRIALS / RESEARCH PROJECTS

Five cancer centres

MAINLAND CHINA

Management service agreement

VIETNAM

Two cancer centres

SINGAPORE

Three centres delivering research

Six cancer centres including flagship Mt Alvernia integrated centre Management of 70+ pharmacies

AUSTRALIA

Four TGA licensed compounding facilities Over 38 cancer centres

One cancer centre

One GMP licensed compounding facility

NEW

17 centres delivering research

Drug stability and research lab

HONG KONG

2022 YEAR IN REVIEW

NEW

RESEARCH

PATIENTS ACTIVE ON CLINICAL TRIALS

182

730 PATIENTS WERE RECRUITED TO INVESTIGATOR INITIATED RESEARCH PROJECTS

363 PATIENTS RECRUITED TO CLINICAL TRIALS / RESEARCH PROJECTS

33 new trials / research projects selected for participation and undergoing start-up

166

154 clinical trials / research projects closed to recruitment but still with workload

46 clinical trials open to recruitment in 2022

patients recruited to phase I clinical trials

58 patients recruited to phase II clinical trials

86

195 patients recruited to phase III clinical trials

24 patients recruited to phase IV trials, registries and RWE

ICON CANCER CENTRE SITES DELIVERING CLINICAL TRIALS / RESEARCH PROJECT OPPORTUNITIES

500+

COMPOUNDING AND PHARMACY

69 ACTIVE PRINCIPAL INVESTIGATORS OF CLINICAL TRIALS / RESEARCH PROJECTS

21 52% PROSTATE CANCER

21 of active Principal Investigators of clinical trials / research projects are women = 31% CLINICAL TRIALS/ RESEARCH PROJECT RECRUTMENT IN 2022

RES EA RC H

L OC A T IO N S

Ade l aid e ( Tenn y son), S A

Auchenfl o w e r ( W esley), QL D

Chermside, QL D

E a s t Melbourn e ( F reemasons), VI C

Farrer Park, SG

Gleneagles, SG

Go l d Coas t

P r i v a t e, Q L D

Go l d Coas t

Un i v e r sit y, QL D

Greenslopes, QLD

Hobart, TAS

Maroochydore, QLD

Moreland, VI C

Mount Alvernia, SG

Mu l gra v e, V I C

North L a k es, QL D

Richmond, VI C

South Brisbane, QL D

Southport, QL D

To o w oomba, QL D

Wellington, NZ

Windsor Gardens, S A

BREAST CANCER

RES EA RC H

LOCATIONS

NEW IN 2023

Cairns, QLD

Mount Elizabeth, SG

Townsville, QLD

Wahroonga, NSW

RESEARCH IMPACT IN 2022

2022 HIGHLIGHTS

CELEBRATING DR JOHN BASHFORD

It is with warm wishes but a heavy heart that we say farewell to Dr John Bashford, Icon Group’s Director of Research who announced his retirement in early 2023.

Dedicated and visionary

John is one of the founding doctors of Icon and since the early 1990s he has played a critical role in the group’s day oncology business. He has been a driving force behind the evolution of private oncology practice, actively advocating for private clinical trials and research, and leading the way for stem cell transplantation.

In 1996, he spearheaded Medicare funding negotiations for stem cell transplantation and became the Director of the Wesley Hospital (Queensland) Stem Cell Transplant Laboratory and Program, the only integrated private service of its kind in Australia. He also helped lead the development of the private Bone Marrow Transplant Program at Wesley which continues to help thousands of patients today.

As founding President of the Private Cancer Physicians of Australia (PCPA), John has sought to improve oncology care, while also making significant contributions to oncology education and research through the Icon Cancer Foundation. His advocacy saw him represent peak organisations – PCPA, MOGA (Medical Oncology Group of Australia), HSANZ (Haematology Society of Australia and New Zealand), and COSA (Clinical Oncology Society of Australia) and lead negotiations with the Australian Government on chemotherapy supply reforms.

Throughout his decorated career, John has held several leadership positions including Chairman, Board of the Wesley Clinic Research Centre, Board Director of PCPA, and Board Chair of Icon Cancer Foundation. He has also been a member of significant clinical advisory boards including Mozobil for preparation of a successful PBS submission in bone marrow stem cell transplantation, Ibrutinib for PBS submission for treatment of chronic lymphocytic leukaemia, Darzalex Advisory Board for treatment of multiple myeloma, MOGA Advisory Committee on PBS matters and Member Implementation Liaison Groups for Medicare Benefits Review – Medical Oncology.

John has created a lasting legacy and his significant contribution has improved patient care. It’s his deep knowledge and vision that has enabled Icon to lead the way in clinical research and play an integral part in medical developments and access to the latest treatments.

Sophie Mepham, Rebecca Clarke, Adam Stoneley, Dr John Bashford

“I had the honour of continuing John’s practice after his semi-retirement in 2017 and it’s been an absolute privilege and reward to care for his patients and hear the impact he has made in their lives. On a personal note, I’m grateful for his clinical advice, mentorship, counsel, and incredible friendship. His contribution to oncology is immense and inspiring. I know there are many clinicians within the Icon network who will echo my compliments and miss his constant leadership and his passion for research.” - Icon Group Chief Medical Director, Dr Ian Irving

Care for patients and families

John’s central focus has always been his patients. When John talks about exceptional healthcare, he asks how we can better serve those in our care.

Even after retiring from clinical practice, he remained in contact with many of his patients and is genuinely invested in their lives and wellbeing. It’s through the heartfelt words and praise from his patients that we see the true impact he has made on so many people.

Over his long and respected career, John has made an indelible mark on the lives of his patients and their families and played a critical role in the evolution of Icon and Australia’s healthcare landscape.

His care, dedication to people and excellence is a shining example of exceptional clinical care. We wish John all the very best in this next phase of life as he enjoys quality time with his loving family.

“When John talks about exceptional healthcare, he always asks how we can better serve those in our care. His dedication to people, quality and excellence exemplifies everything we value at Icon. Personally, I can’t begin to thank John enough for his wise counsel and stead hand, particularly as we faced down the pandemic. Cometh the hour, cometh the man and this was one of John’s finest hours as a clinician and a leader.”

- Icon Group CEO, Mark Middleton OAM

In my 25 years working in oncology clinical trials, I have had the privilege of working with some of the best doctors in Australia and the UK, but working for Dr John Bashford was without a doubt, one of the finest. As Group Director of Research, he led our team clinically with dedication, commitment, vision, and passion. His door was always open to any of us. He leaves an incredible legacy that will remain within the research team for many years, and he will be missed immensely. Thank you, John for your unwavering commitment to our patients.”

- Icon Group Executive Manager – Research, Sophie

Mepham

“John will be greatly missed both at an organisational level but also for many clinicians at Icon on a personal level. The outstanding quality about John was that at the end of the day his decision would always be of benefit not only as a clinician personally, but to the organisation and the people he represented. Rationality and doing what was right and proper for John would always win over passion and emotion. This attribute for me defines leadership. Over these last 35 years I have developed enormous respect for John, but I believe we have also become good friends. Friends are the relatives one chooses themselves, and I have chosen well. All I can do is thank John from the bottom of my heart for everything he had done and achieved for us and to wish him and his family a long, happy, and healthy retirement.”

- Dr Paul Eliadis AM

Dr John Bashford receiving the Senior VMP award from Dr Luis Prado

Celebrating International Clinical Trials Day

NEW DIRECTIONS IN MEDICAL ONCOLOGY AND HAEMATOLOGY

In 2022 Icon’s research portfolio formally extended its scope with global expansion, increase in uptake of Investigator Initiated Trials (IITs) and a resource commitment to Real-World Evidence (RWE) projects. This investment in dedicated IIT and RWE teams has the potential to augment Icon Group’s trial capability and attract new opportunities in our longstanding medical oncology and haematology portfolio. The following showcases some of the notable achievements in 2022 and how Icon is keeping abreast of industry trends through strategic partnerships.

NEW MEDICAL ONCOLOGY AND HAEMATOLOGY TRIAL STRATEGIES

Calcium and Vitamin D Study

Last year saw a significant uplift in Real World Evidence activities rising from the 2021 level of 2% of recruitment to 31% of total recruitment in 2022. This increase was due to Icon’s participation in an observational project assessing the compliance with Calcium and Vitamin D supplementations in patients receiving bone resorptive agents.

This project was led by A/Prof Jermaine (Jim) Coward as Principal Investigator with operational research leadership from Ashleigh Smith as Associate Investigator and Pharmacist. The study recruited 112 patients, and using pharmacist and patient conducted surveys, the project assessed:

• Rates of compliance to recommendations outlined by eviQ best practice

Patient adherence to prescribed Calcium and Vitamin D therapy

• Barriers to patient adherence

• Patient understanding of the rationale behind therapy

• Demographic factors for patients prescribed bone resorptive agents

Standout trials

The addition of research at Icon Cancer Centre locations at Adelaide (in 2020) and Hobart (in 2021) has allowed for wider clinical trial opportunities across multiple regions and efficient capability to conduct multisite sponsored clinical trials. Standout examples in 2022 include:

• ANZUP’s DASL-HiCaP study was the single highest recruiting externally sponsored clinical trial. This trial is significant as it recruited across both medical oncology and radiation oncology modalities and increased our research capacity across three locations – Adelaide, Gold Coast and Hobart.

• Roche’s GO42784 liDERA trial was Icon’s second highest recruiting externally sponsored clinical trial. LiDERA evaluates the efficacy and safety of an adjuvant selective estrogen receptor degrader / down regulator in participants with estrogen receptor-positive, HER2negative early breast cancer. This trial experienced high recruitment numbers at Adelaide, Hobart, and Wesley (Auchenflower) locations.

Gilead’s IMMU-132-13 TROPICS-04 trial evaluating patients with a diagnosis of metastatic or locally advanced unresectable urothelial cancer saw steady recruitment and was the first trial Icon has participated in across international borders with recruitment at Farrer Park (Singapore), Hobart and Wesley (Auchenflower).

Phase I opportunities

Across the industry globally, recruitment and patient activity in early phase oncology clinical trials decreased in 2021 with a follow-on effect in 2022. The cause of this anticipated decrease relates to significant improvements in the knowledge of how patients can be treated more effectively and with reduced toxicity, by offering more targeted therapies related to genomic profiling indicators.

The number of early phase clinical trials for patients where eligibility requires no specific genomic characteristics have unfortunately reduced in number. Icon’s experience in 2022 was indicative of this overall global trend across industry with the new much more difficult focus on treatment for very specific diagnoses or rare tumour types.

To maintain our strong Phase I capabilities and align with industry trends, Icon Group partnered with the Australian Genomic Cancer Medicine Centre (Omico) to participate in the Precision Oncology Screening Platform Enabling Clinical Trials (PrOSPeCT) This platform study will sequence the genomes of more than 20,000 cancer patients, many with rare and challenging tumours, to identify the best possible treatment and potential trial opportunity.

This collaboration between the private and public sector will allow Icon patients to have greater access to clinical trial opportunities and bring more externally sponsored trials for very specific indications to Icon cancer centres in 2023 and beyond.

Calcium and Vitamin D study reached 95% of its target accrual

Joined the Genomic Cancer Medicine Centre (Omico)

International trial recruitment to IMMU132-13 TROPiCS-04

increase in clinical trials

HOBART HIGHLIGHTS

In its first full calendar year of delivering clinical trials, Icon Cancer Centre Hobart continues to increase access to clinical trials for more Tasmanians.

patients recruited

clinical trial visits completed

Medical Oncologist, A/Prof Louise Nott and State Clinical Research Coordinator Lead for Tasmania and Victoria, Rossa King, have been instrumental in the consistent activation of new trials and formalisation of research partnerships to grow the portfolio.

Under their leadership, the research team tripled and activated 20 trials and completed over 200 clinical trial visits.

The centre now has the capability to deliver trials across medical oncology and radiation medicine in breast, prostate, skin, genitourinary and lung cancers, specialising across Phase II and III trials.

Phase II and III trials

Specialising in Capability across

• Medical oncology

• Radiation medicine

As Australia’s second highest recruiters to the CANVACCS trial (examining patient perspectives on COVID-19 vaccine), the team co-authored a publication in September 2022 by A/Prof Nott further examining vaccine hesitancy among Australian patients with breast cancer.

Looking ahead, Icon Hobart will continue to build local partnerships and work alongside the public sector to bring more new and emerging treatments to Tasmania.

A/Prof Louise Nott, State Clinical Research Coordinator Manager (TAS/VIC), Rossa King, Dr Cristina Moldovan and A/Prof Michael Jones

KICKING GOALS ON THE GOLD COAST

Icon Cancer Centre Gold Coast University Hospital (GCUH) and Icon Cancer Centre

Gold Coast Private have had a milestone year of delivering radiation oncology clinical trials.

Gold Coast based Principal Investigators, Dr Eric Khoo and Dr Andrew Oar alongside Senior Clinical Research Coordinator, Hayley Brennan have delivered impressive growth with several highest State recruitments and the activation of Investigator Initiated Trials and projects.

The 2022 calendar year continued the recruitment to the DASL HiCAP trial, with the team screening over 40 patients and recruiting 12. DASL HiCAP is a randomised Phase III double-blinded trial assessing the addition of a new oral hormone drug, darolutamide to the standard of care treatment for very high-risk prostate cancer patients.

Icon Gold Coast was the highest recruiting site in Queensland, third highest in Australia and sixth globally. Gold Coast was also the state’s highest recruiter and second nationally for the MASTERPLAN trial - a randomised phase II study of MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer with High Risk and Locally Advanced Disease.

In 2023 and beyond, the team is expected to activate the CONSOLE trial – an Investigator Initiated Phase III trial looking at conventional or stereotactic radiation therapy for the palliation of non-spine bone metastases. The sites are targeting to recruit 10 – 20 patients, setting a goal for high recruitment within Queensland participating sites.

The team is focused on activating new trials that will meet KPIs for Icon and Queensland Health, with a particular interest in breast and gastrointestinal cancer trials. In the latter half of 2023, Icon Cancer Centre GCUH will have an additional Varian linac equipped with HyperArc which will increase contribution to the HyperArc registry and continue to provide opportunities for further in-house research, including cross site collaboration and radiation therapist, nursing and medical physics led trials.

Highest Queensland recruiter for

Australia’s 2nd highest recruitment to the MASTERPLAN trial

2nd Australia site activated for the Varian HyperArc registry

1st 2023

CONSOLE trial activation set for

Dr Andrew Oar, Dr Matthew Neve, Senior Clinical Research Coordinator, Hayley Brennan, Dr Eric Khoo and Dr Preeti Bagga

STEPHEN’S CHANCE TO HELP FUTURE PROSTATE CANCER PATIENTS

The 55-year-old from Melbourne viewed it as an opportunity to make a difference for other men diagnosed with prostate cancer.

“The team at Icon were very helpful and supportive during my treatment, so I was happy to be part of the trial to give something back and to help with advancements in treatment to support men diagnosed in the future,” says Stephen.

“If (researchers) can gather all the facts, then hopefully they can beat this disease down the track.”

Prostate cancer is the most common cancer diagnosed in Victorian men, with the number of new cases increasing each year.

For many men, prostate cancer treatment involves significant side effects including urinary incontinence and sexual dysfunction, along with the emotional distress both a cancer diagnosis and the impact of treatment can cause.

Stephen was diagnosed with prostate cancer in 2020. “I had no symptoms or family history,” says Stephen.

“During a routine check-up, my doctor did a (Prostate-Specific Antigen) PSA test and the results showed a high reading.

“I was sent to a urologist, who ordered an MRI, which picked up something. I then had a biopsy, which determined it was cancer, but it was small and detected early, so they decided to monitor it.

“In September 2021 I received the treatment which was only one treatment, and it all went smoothly. I didn’t experience any side effects.”

Since then, Stephen has undergone an MRI, which showed the cancer has gone.

He now undergoes three-monthly PSA tests and is maintaining a positive attitude.

“When you’re told you have cancer, you naturally wonder what is ahead of you,” says Stephen.

“But I feel like one of the lucky ones. I’m very grateful to my GP, as my cancer was detected early, and my treatment was smooth sailing.

“The team (at Icon) explained everything clearly and they were very caring and professional.

“I’ve been reminding my family and friends to get checked and monitor for any symptoms.

“Cancer doesn’t discriminate. But it’s important to remember that if you detect and treat it early, you can overcome it.

“I encourage people to be vigilant and keep on top of their health checks. It could save your life.”

IF (RESEARCHERS) CAN GATHER ALL THE FACTS, THEN HOPEFULLY THEY CAN BEAT THIS DISEASE DOWN THE TRACK.”

When Stephen was offered the opportunity to take part in a clinical trial through Icon Cancer Centre, he jumped at the chance.

A FOCUS ON INVESTIGATOR INITIATED TRIALS

Varian HyperArc technology

Icon’s Investigator Initiated Trials (IIT) team was established early in 2021 and is responsible for the development and management of the IIT portfolio. The IIT team are experienced in all aspects of study development from concept initiation and protocol development through to publication. This work is supported and sponsored by Icon Cancer Foundation.

In 2022 Icon made significant leaps forward in the IIT portfolio and capacity. With the execution and publication of the Icon IIT Framework, two new trials opened to recruitment, and a focus on developing collaborative partnerships, the year saw record recruitment numbers and further interest in the development of IIT strategic growth.

2023 and beyond will see expansion of Icon’s IIT capacity to increase efficiencies of current IITs and support new initiatives. This will include expansion into all areas of cancerous and non-cancerous conditions as well as pharmacy studies, theranostics, medical oncology and haematology trials aimed at improving patient treatments and outcomes. In 2023 the team also aims to activate the first randomised control trial under the new Icon IIT Framework and expand trials into a multicentre model.

The following outlines our significant IIT achievements of last year including a milestone partnership, trial snapshots and a major publication.

VARIAN RESEARCH FRAMEWORK AGREEMENT

Varian and Icon Group have entered a global five-year strategic partnership, which includes the development of ongoing clinical and technical research programs to advance cancer care.

The collaboration allows for the development and execution of a number of radiation medicine studies supported by Varian which will meet the strategic direction of both organisations and improve radiation oncology technologies.

In 2023, the two organisations will continue the commencement of work on three new research projects under this agreement and focus on evolutions in radiation software, treatments and techniques.

TREMOR TRIAL HYPERARC REGISTRY

Icon became the first international participant in the Varian-initiated HyperArc® Registry. HyperArc is an end-to-end treatment workflow which allows patients to receive radiotherapy to multiple brain tumours in a safe and streamlined manner.

The HyperArc registry has been initially opened at three Icon Cancer Centre locations across Australia (Gold Coast, Maroochydore and Greenslopes) and is coordinated centrally by the IIT team, while being supported locally by radiation oncologists, radiation therapists and medical physicists.

Data collected in the registry will be used to gain a real-world understanding of outcomes following HyperArc treatment. The HyperArc registry will be opened at further Icon Cancer Centre locations across the Australian Icon network in 2023, with ambitions to also implement the registry at international locations.

LIBERATE REGISTRY

Dr Andrew See and A/Prof Jeremy Grummet are co-investigators of LIBERATE which is the only clinical registry monitoring patients who have undergone focal brachytherapy in Australia. As part of the LIBERATE clinical registry, focal brachytherapy treatment is now available at Icon Cancer Centre Geelong, Icon Cancer Centre Richmond and Icon Cancer Centre Freemasons.

Focal brachytherapy is a highly-targeted technique which involves the implantation of small radioactive seeds directly into the cancerous area of the prostate. Icon’s LIBERATE clinical registry, which was launched in 2019, monitors men who have undergone focal brachytherapy for low to intermediate risk prostate cancer at Icon Cancer Centre in collaboration with Epworth Healthcare. The registry will collect data for 5 years following treatment to determine the effects of treatment on long term quality of life and rates of cancer control.

Funding for the LIBERATE clinical registry was provided by the Epworth Medical Foundation, Icon Cancer Foundation and supported in kind by Icon Cancer Centre.

The TREMOR clinical trial represents strategic expansion of Icon’s radiation medicine IIT portfolio into benign (non-cancerous) conditions. TREMOR brings together a multidisciplinary team led by Principal Investigator, Radiation Oncologist, Dr Kevin So, involving external collaborators in the field of neurology and neurosurgery. Funding for the TREMOR clinical trial was provided by the Epworth Medical Foundation, Icon Cancer Foundation and supported in kind by Icon Cancer Centre. The trial aims to evaluate the effectiveness of advanced stereotactic radiosurgery (SRS) for the treatment of essential or Parkinson’s related tremor.

Conventional treatment for tremor within the clinical trial setting involves deep brain stimulation, an invasive surgical procedure that places electrodes or needles into the central part of the brain and a stimulator into the chest wall.

Stereotactic radiosurgery is non-invasive and involves a highly targeted form of radiation treatment that delivers high doses of radiation while sparing the surrounding tissue and organs and has been used for many decades to treat benign (non-cancerous) and cancerous brain conditions.

Dr Kevin So says the advanced treatment offers new hope for people afflicted with tremor who face limited treatment options.

TREMOR is a welcome and exciting clinical trial for the many Australians and people across the world impacted by essential tremor and Parkinson’s disease. These conditions can be devastating for patients who may no longer be able to perform the simple tasks we often take for granted, such as feeding ourselves and brushing our teeth, especially when they are unable to receive conventional treatment. Our hope is that this research will support the thousands of Australians who develop tremor to access advanced, non-invasive radiation treatment which improves their quality of life.”

- Dr Kevin So

PROSPER-82 PUBLICATION

The results of the ProSPER-82 trial, led by Radiation Oncologist Dr Andrew See, were published in 2022 in the journal Radiation Oncology. The ProSPER-82 trial, involving 70 men with localised prostate cancer, was the first to investigate the combination of very-high dose radiation therapy (up to 82 Gy) and the use of a protective gel spacer placed between the prostate and the rectum (back-passage).

Without the use of a gel spacer, up to one in five men may experience significant changes to their bowel function due to radiation therapy, such as bleeding or pain. In the ProSPER-82 study, no significant long-term side effects were observed up to three years following treatment and participants reported that their quality of life was maintained. In addition, cancer control was achieved in 90% of men, demonstrating that this approach is both safe and effective.

Funding for the ProSPER-82 clinical trial was provided by the Epworth Medical Foundation, Icon Cancer Foundation and supported in kind by Icon Cancer Centre.

Published on 25 July 2022 in the journal Radiation Oncology

Icon and Varian signed a

Highest recruitment to date

Activation of the TREMOR trial

TARGETING THERANOSTICS AND MOLECULAR ONCOLOGY

Under the confident leadership of Group Director Molecular Oncology, Julie Crouch, 2022 marked significant progress in the development of Icon’s global theranostics program. Icon Cancer Centre North Lakes in Brisbane’s northern suburbs will be the Group’s first centre to offer a comprehensive theranostics service set to be operational in 2023. The centre has the infrastructure and resources to support both a clinical service and provide patients with access to quality clinical trials that contribute to developments in hyper-personalised cancer treatments.

The oncology segment market for theranostics is expected to grow to an excess of $129 billion by 2025, providing a significant pipeline of industry funded clinical trials. There is extensive interest from pharmaceutical companies in the field of molecular oncology who are interested in partnering with Icon to deliver theranostics clinical trials. Over the next 18 months, Icon has a pipeline of locations that will provide theranostics services and continued conversation with industry partners to activate theranostics trials across Australia and Singapore.

Diagnostic imaging used in theranostics

First Icon Theranostics Program to begin operations in 2023

Adelaide, South Australia site selected for Telix solid tumour trial

Theranostics trials under review in Icon Singapore

MOLECULAR ONCOLOGY PRACTICE UNIT

The Molecular Oncology Practice Unit (MOPU) was formed in September 2022 to support the molecular oncology strategy to initially include theranostics, interventional oncology, and radiopharmacy. The membership of the MOPU includes representatives from quality and risk, research, nursing, pharmacy, medical physics, and nuclear medicine, providing a broad scope of expertise. Research and clinical trials are currently being discussed and assessed at the forum, setting the strategic agenda. A Theranostics Research Committee will commence in 2023.

TELIX SOLID TUMOURS TRIAL

Icon Cancer Centre Adelaide in South Australia has been selected as the lead private site for the Telix Solid Tumours study with CRO Novotech. This is a Phase 1b Dose Escalation/Expansion study of the combination of 177Lu-TLX250 and peposertib in patients with carbonic anhydrase IX (CAIX) expressing solid tumours. This trial is expected to commence in the second quarter of 2023 and executed in collaboration with Jones Radiology.

NOVARTIS THERANOSTICS TRIALS

Singapore has two potential theranostics trials under review; the Novartis phase 111 AAA603D1230 breast trial is a study of [177Lu]Lu-NeoB in combination with capecitabine versus capecitabine alone for the treatment of post-menopausal women with hormonal receptor-positive, human epidermal growth receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. Novartis phase 111 CAAA603E1230 glioblastoma trial, a study of [177Lu]Lu-NeoB versus Lomustine for the treatment of Recurrent Glioblastoma. Icon looks forward to further collaboration with Novartis in 2023 and beyond in this exciting new area of treatment and research.

CELEBRATING A/PROF DUSAN KOTASEK

In early 2023 we bid a bittersweet farewell to A/Prof Dusan Kotasek who announced his retirement. Dusan dedicated his life to the field of oncology and research and his over 30-year career leaves a lasting impact on those he has worked with and cared for.

Advocating for more research

Dusan alongside his colleague, Dr Francis Parnis founded the Adelaide Cancer Centre (ACC) and Ashford Cancer Centre Research (ACCR) in 1995. At that time cancer services were virtually all centralised in large public hospitals and Dusan and Francis saw a need to provide greater access to cancer care and clinical trials within the private setting.

For Dusan, clinical trials are an essential component of providing the best possible cancer care and his advocacy for clinical research saw no bounds.

In 1997 the team embarked on their first clinical trial involving the use of a novel antiemetic oral medication for the prevention of chemotherapy associated nausea and vomiting. Since that time, ACCR grew from strength to strength and by the early 2000s the group had six clinicians and four research professionals, and today has 23 clinicians and 18 research professionals.

Phase I trials became a major focus of the team which brought further partnerships and increased access to new and emerging treatments. Today, over 70% of the group’s Adelaide trials are Phase I.

In late 2020 ACC and ACCR became part of Icon Group. This was a natural next step in building capacity in South Australia and bringing together the two organisations shared values. For Dusan this evolution would bring a new level of growth and sustainability and ultimately provide greater opportunity for all patients through access to the latest research and clinical trials.

The addition of ACCR doubled Icon Group’s research capacity and it is thanks to Dusan’s vision and dedication that Icon’s South Australia cancer centres remain a leading and respected centre for research. South Australia is a growing hub for clinical trials and often leads the way in trial recruitment across national and international trials. Dusan has played a significant part in the region’s healthcare landscape and his counsel, knowledge and dedication to research and oncology will be missed.

A/Prof Dusan Kotasek with the Icon Adelaide team

A career in care

Throughout his career, he has been a pioneer in the development of new cancer treatments and has worked tirelessly to improve the quality of life for his patients. His compassion, empathy and understanding of the unique challenges faced by cancer patients has made him a trusted figure among his colleagues, patients, and their families.

After retiring from clinical practice, Dusan continued to play an active part in research and has been author of over 60 publications and 80 abstracts. His expertise in oncology has earned him several accolades and achievements and his contribution to the medical community will continue to make a lasting impact.

As he embarks on this new chapter, we extend our deepest gratitude and warm wishes to Dusan and thank him for his remarkable service.

DUSAN DEDICATED HIS LIFE TO THE FIELD OF ONCOLOGY AND RESEARCH AND HIS OVER 30-YEAR CAREER LEAVES A LASTING IMPACT ON THOSE HE HAS WORKED WITH AND CARED FOR.”

Dr Francis Parnis, Mark Middleton OAM, and A/Prof Dusan Kotasek

CANCER DIAGNOSIS PROVIDES VALUABLE LIFE LESSONS FOR ROBERT

Queensland cattle farmer, Robert has always led a busy lifestyle. The 64-year-old manages a large rural property spanning over 20,000 acres with close to 15,000 head of cattle.

He jokes that he “didn’t have time” for a cancer diagnosis in July 2021.

“I was urinating a lot, which was the first sign something wasn’t right. I thought if I cut down on the amount of water I was drinking, it might help. But it didn’t.

“I went to the doctor who ordered a (ProstateSpecific Antigen) PSA test and it came back with a high result of nine.

“I was sent to see a specialist and from there I was told I had an aggressive form of prostate cancer.”

The father of three says the diagnosis came as a huge shock to himself and his family, who help oversee the farm.

“We have 25 workers and a huge property to run. That doesn’t stop because of a cancer diagnosis,” says Robert.

“But I knew I had to put my health first.”

Robert underwent radiation therapy at Icon Cancer Centre Toowoomba from February to May 2022, which is over 200km away from his property. During his ten weeks of treatment, Robert would travel to and from treatment twice a week, staying in Toowoomba on Monday, Tuesday, and Thursday nights.

He says although it was hard to be away from his family, he was grateful for the support he received from the Icon Cancer Centre Toowoomba team.

“They are the nicest people I’ve ever met,” says Robert.

“They looked after me so well. I was actually overwhelmed by it.

“When they asked me to participate in the clinical trial, I wanted to do it. If it helps future prostate cancer patients, it’s worth it.”

Robert is now back on the farm working alongside his partner and children.

He says he has taken some valuable life lessons from his cancer journey.

“It’s definitely changed my outlook on life,” he says.

“I’ve always been someone who worked hard, but now I know when it’s time to take a break.

“I know I have to look after myself so I can keep going.”

WHEN THEY ASKED ME TO PARTICIPATE IN THE CLINICAL TRIAL, I WANTED TO DO IT. IF IT HELPS FUTURE PROSTATE CANCER PATIENTS, IT’S WORTH IT.”

PHARMACY POTENTIAL

Icon Group’s nation-wide pharmacy services allow the Group to deliver a true end-to-end research model. With long-standing relationships with hospital, pharmaceutical and manufacturing, Icon provides a collaborative and connected ecosystem conducive to quality management of clinical trials.

Pharmacy Practice Unit

The Group’s Pharmacy Practice Unit (PPU) Central Clinical Trial Support Team was established in 2022 with oversight on all Icon Group pharmacy clinical trial activities to ensure compliance with clinical trial regulations, guidelines, and procedures. The implementation of the team has allowed the expansion of clinical trial support services to include start up activities in most Icon Group pharmacies who conduct clinical trials and incorporates feasibility review, budget and contract negotiations, the establishment of billing processes, and provides training and support for all pharmacy team members.

Future direction will see a focus on the continued implementation of the Group’s PPU Central Clinical Trials Support Team with an aim to assist sites with specialised clinical trial tasks, particularly in relation to contracts and invoicing. The team will also create further awareness of trials involving Phase I products and other products that may require special handling to maintain a high level of quality control. This centralised support will allow pharmacy team members onsite to dedicate more time to patient care and other essential clinical trial tasks.

The key to the success of pharmacy support of clinical trials will involve the development of a road map and the establishment of a reporting,

governance and risk management tool, and new policies and procedures. In 2023, the team will roll out support to an additional 10 Icon pharmacies which run over 180 active trials. This support will include additional training and ensure appropriate Good Clinical Practice (GCP) training is completed.

Sponsored Clinical Trial Fee Schedule review

The sponsored clinical trial fee schedule was updated after a major review and adopted across all Icon Group pharmacies. This review addressed several emerging issues, in particular the increasing complexity and time required to compound certain trials. Other measures included - introducing a tiered pricing system to give clearer guidance to staff on budgeting accordingly and upskilling team members on addressing payment issues for complex compounding, in particular dose escalation studies requiring a high number of vials.

Trials transition of Grey Street and North Sydney pharmacies

The clinical trials team successfully transitioned the Grey Street and North Sydney new pharmacy sites along with their 16 established clinical trials from an alternative pharmacy provider. In addition to systems and process support, a range of communication and training activities took place to support team members to effectively navigate the transition.

COMPOUNDING CAPABILITIES

Icon Group’s compounding arm, Slade Health assists hospitals with clinical trials by providing compounding services from our TGA / Medsafe-licensed facilities. Currently supporting over 200 clinical trials, our experience covers Phase I-IV studies, primarily in oncology and haematology.

Quality clinical trials

Slade Health’s clinical trials service includes national clinical trial co-ordination among its TGA / Medsafe-licensed compounding facilities to ensure relevant criteria is met for the compounding of investigational products. Each compounding facility has dedicated clinical trials team members who have complete oversight over the management and segregated storage of clinical trial drugs in validated and monitored equipment.

Slade Health also supports the administrative work required in clinical trials by providing relevant manufacturing records and maintaining training documentation to always guarantee compliance to Good Clinical Practice (GCP) and Good Manufacturing Process (GMP).

With validated shippers, Slade can assure the safe and secure cold chain or ambient transport of clinical trial products to hospitals on time.

Slade Health’s South Australia compounding facility

Serviced 246 clinical trials in Australia, 70% of which are in Phase II / III

Stability laboratory

Since its opening in March 2022, the Drug Stability Testing and Research Laboratory has worked on the generation of scientific data to ensure the quality and stability of the products manufactured in Slade Health. The data generated in the lab has been used to support the extension of the shelf-life of products from 24 hours to 90 days. The extension of the shelf life provides great flexibility to patient treatment, enabling Slade to deliver these products to rural and remote locations across Australia, and allow patients to receive their treatment closer to home.

The Drug Stability Testing and Research Laboratory has a state-of-the-art facility that is used to develop and validate analytical and biological methods that are specific to each product. The laboratory also supports the testing of devices and containers used in the manufacturing process ensuring that each component of the final product is of the highest quality. In 2022 and beyond, the laboratory team will expand to facilitate more product testing and ultimately improve access to care.

90% oncology, 10% non-oncology

Compounded over 3697 clinical trial products

Established clinical trial presence in New Zealand with successful onboarding of 38 clinical trials from hospital partner, Te Toka Tumai

Stability laboratory

Increasing shelflife to 90 days for certain molecules

Slade Health’s Drug Stability Testing and Research Laboratory at Mt Kuring-gai, New South Wales

A SPOTLIGHT ON TRIALS IN SINGAPORE

The clinical trials department was established in early 2021 and has experienced significant growth in the last 12 months. The team is led by Director of Clinical Trials (ASEAN and Hong Kong), Joanne Chio and Singapore Research Lead and Committee Chair, Dr Hsieh Wen-Son.

In its first full calendar year of delivering a dedicated clinical trials program, the Singapore team signed a number of industry partnerships to attract a broad range of clinical trials and activated several new trials including Icon Group’s first involvement in a paediatric oncology trial.

The opening of the new integrated Icon Cancer Centre in Mount Alvernia will allow for continued growth of clinical trials. This centre will be the second headquarters for Icon Singapore’s clinical trials (First headquarters at Icon Cancer Centre Farrer Park) with the cutting-edge facilities able to attract milestone trials, including nuclear medicine/theranostics.

Icon Cancer Centre at Mount Alvernia has achieved regulatory approval from the National Environment Agency and Ministry of Health and the centre was officially launched on 11 January 2023. The centre will provide theranostics services in 2023 including clinical trials.

Oncoshot and Roche MOU

In October 2022, Icon Cancer Centre Singapore inked a partnership with Oncoshot, a collaborative platform for cancer patients and oncologists, and Swiss pharmaceutical firm Roche. This collaboration is the first in Southeast Asia to digitise the genomic data of cancer patients to better identify and match patients to suitable ongoing trials.

Healthcare professionals can make more informed decisions for their patients regarding potential treatment options and help accelerate the process of matching patients to the most suitable clinical trial. So far 250 patient databases have been digitised with ongoing work in 2023 and beyond.

General Manager - Roche Singapore, Yeoh Ying Ying, CEO - Icon ASEAN and Hong Kong, Serena Wee, CEO - Oncoshot, Dr Huren Sivaraj

MOU signing 27 October 2022

Training

As the number of clinical trials in Singapore and the focus on patient recruitment increases, there is a need to upskill and equip teams with resources and quality training to deliver high-quality care. In 2023 Icon will aim to start a research exchange program which will allow Singapore research teams to be trained within Icon sites across Queensland and New South Wales. This will include exposure to Phase I trials and extensive hands-on clinical trial training.

Clinical Trials WebApp Launch

In 2022 the team launched an Icon Clinical Trials WebApp for Principal Investigators and Co-investigators in Icon to provide greater collaboration and easy access to current clinical trial information, including protocols, informed consent, eligibility criteria, and study schema. This app allows doctors to access relevant information with ease and help improve patient recruitment.

Established a second clinical trials headquarters

Signed a milestone MOU with Oncoshot and Roche

Launched a clinical trials WebApp

GOVERNANCE AND QUALITY

Governance and quality for research at Icon continues to be a strength and focus. 2022 saw continued evolutions of a global governance framework and the implementation of the Investigator Initiated Trials Framework.

Research governance and quality is governed by the Icon Group Executive who set the strategic and operational plans for all research activities at Icon and has specific responsibilities to:

• Provide managerial leadership in delivering care and supporting the strategic direction and the culture set by the Board for the research division

• Approve the approach to planning, implementing, evaluating, and improving of research practice and quality

• Enable the provision of support, resources, training, information, and opportunities to the workforce to provide safe and quality care for research participants

Discuss clinical quality and safety data from research participants with the Global Research Committees and the Executive Leadership Team about matters including consumers feedback, audit results, accreditation reports, incidents, compliments, and complaints

• Monitor and evaluate implementation progress of research clinical governance and quality activities and take further action, as needed

Icon’s research and cancer division’s quality teams have established a working relationship to ensure all accreditation standards are met. The working group was established in 2022 to review and integrate the National Clinical Trials Governance Framework into Icon Group’s Clinical Governance Framework through the support of existing documentation and processes.

The National Clinical Trials Governance Framework

In 2022, the Australian Health Service Safety and Quality Accreditation (NSQHS) scheme implemented the National Clinical Trials Governance Framework. As a result, all health service organisations in Australia will be assessed concurrently for clinical, corporate services and clinical trial service provision.

To provide health service organisations time to implement the National Clinical Trials Governance Framework, for the first three-year accreditation cycle, the organisation will be assessed on a maturity scale. The maturity scale is assessed from having established systems, growing systems, or initial systems in place to meet the NSQHS standard for clinical trial service provision.

Beyond the first three-year accreditation cycle, health service organisations will transition fully to the assessment of clinical trial services under the AHSSQA (Australian Health Service Safety and Quality Accreditation) Scheme and be assessed as either having met or not met the actions within the NSQHS Standards Clinical Governance Standard and Partnering with Consumer Standards and receive 60 days to remediate.

IIT Framework

The IIT Framework outlines the process for development, management, and maintenance of the Icon IIT portfolio. The IIT Framework allows for Icon to provide a clear pathway for study concept development and provide an end-to-end service. This IIT Framework underwent a major revision to streamline processes and ensure studies were being managed with a high focus on quality. This framework also allows for Icon to partner with external organisations to develop and produce a high quality IIT program anywhere in the world.

FUTURE STRATEGY

A MESSAGE FROM CO-DIRECTOR RESEARCH (RADIATION MEDICINE), A/PROF JONATHAN RAMSAY

Icon Group will continue to invest in clinical trials and research and lead the way in providing access to new and emerging treatments to turn the dial on oncology treatment and beyond. Future direction will see a focus on new personalised treatments and precision medicine, the ongoing exploration of revolutionary Real World Data and the continued expansion of the Group’s international trials portfolio.

As Co-Director of Research I’m looking forward welcoming new leadership

and continuing to onboard more trials, investigators, and partnerships. I’m particularly excited for the next five years as we embark on an ambitious strategic plan which will drive forward our reach and capability to provide access to more trials and ultimately new and exciting treatments.

Together we’re committed to changing the face of cancer care and contributing to advancements in global healthcare so people can share in more memories and live their best possible lives.

A/PROF JONATHAN RAMSAY

TOGETHER WE’RE COMMITTED TO CHANGING THE FACE OF CANCER CARE AND CONTRIBUTING TO ADVANCEMENTS IN GLOBAL HEALTHCARE SO PEOPLE CAN SHARE IN MORE MEMORIES AND LIVE THEIR BEST POSSIBLE LIVES.”

MBCHB, MSC, MD, FRANZCR, FRCP

THERANOSTICS

There will be a continued focus of embedding Icon’s global Theranostics Program with a comprehensive clinical trial and registry program. Icon aims to be a provider of choice for theranostics research initiatives alongside the expansion of the group’s trial capabilities and offering.

REAL WORLD DATA

In 2022, Icon Group commenced an initiative researching how the organisation can use Real World Data (RWD) to provide better treatment opportunities for Icon patients. RWD provides evidence of the usage and potential benefits or risks of a medical product. Common sources include electronic health records (EHRs), hospital episode data, claims data (PBS and MBS) and patient registry data (product and disease), chart reviews, clinical audits, and observational cohorts. RWD is an evidence base made available from clinical trials and research projects to provide a more complete picture of treatment effectiveness and safety within a real-world patient population.

The advantages of RWD compared with normal clinical trials are that they are conducted often without the need for patient recruitment, allow safe research on high-risk groups and facilitate rapid access for data retrieval. Combined with clinical trial data, RWD can

NEW GEOGRAPHIES

There will be a continued focus on expanding Icon’s highly regarded clinical trials capabilities in more Icon Group locations. The Group’s mature research operations allow for efficient and effective growth opportunities in existing centres as well as new

Icon will seek further opportunities to establish clinical and technical experience in medical physics, dosimetry, radiochemistry, and operations to support theranostics services and set the agenda to deliver high quality theranostics trial operations globally.

be used to support claims of efficacy or safety in reimbursement applications, regulatory approvals or monitor outcome in the post-marketing setting. It is often used in situations where the data is scarce or where clinical trials are not feasible or ethical (e.g., rare diseases and paediatric populations).

A dedicated team has been created to identify the data that the organisation collects, provide an additional layer to ensure the accuracy and completeness and then report on these datasets to provide Icon with a greater understanding of the Icon Cancer Centre patient population in addition to participation in Phase IV studies, observational studies, and other Real World Evidence opportunities. The intent of this initiative is to ensure that Icon Group’s mission is more effectively delivered by further understanding the complete patient experience outside of the routine care pathway or clinical trial participation.

locations beyond Australian shores. This will see Icon focus on activating new trials and research projects in Singapore and the wider ASEAN region and grow alongside the Group’s services into new geographies.

THERANOSTICS REAL WORLD DATA NEW GEOGRAPHIES

Aims to be a provider of choice for theranostics research

Dedicated team assessing data to improve the patient experience

Exporting a proven research model to more locations

ACKNOWLEDGEMENTS

Icon would like to warmly thank all the doctors and research team members for their dedication to the promotion and delivery of clinical trials. Thank you to our sponsors and partners for continuing to work collaboratively to increase access to clinical trials and help reduce the growing global cancer burden. We also extend special thanks and best wishes to our patients, whose participation in clinical trials makes it possible to discover groundbreaking new treatments.

We warmly acknowledge the valued support of donors to Icon Cancer Foundation (ICF), an independent not-for-profit registered charity whose mission is to promote, initiate and support clinical trials and research, striving towards a brighter future for cancer patients and communities. ICF is committed to improving patient access to new and emerging treatments by raising awareness of and sponsoring Investigator Initiated Trials (IITs).

Community fundraising is crucial to the delivery of IITs as they are not sponsored by large pharmaceutical companies and involve ongoing costs and resources to deliver vital and often unique research to advance medicine. All funds raised for ICF support the delivery and execution of IITs including trial management, recruitment, data collection and publication, and ongoing trial patient support including access to transport, accommodation and clinical research coordinators and allied health professionals.

Together we will continue to provide hope and opportunity to patients today and tomorrow.

APPENDICES

RESEARCH PARTNERS

Abbisko Therapeutics Australia Pty Ltd

Abbvie

Accendatech

Acerta Pharma LLC

Adagene

Agenus Inc

Akeso BioPharma Co

Alexion Pharmaceuticals

Alkermes, Inc.

Alphamab Oncology

ALX Oncology Holdings

Amgen Inc

Antengene Corp

Arcus Biosciences

Astellas Pharma Inc

AstraZeneca

Atomic Oncology Pty Limited

Atridia Pty Ltd

Australasian Gastro-Intestinal Trials Group (AGITG)

Australasian Leukaemia & Lymphoma Group (ALLG)

Australasian Myeloma Research Consortium (AMaRC)

Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)

Australian Clinical Labs

Avance Clinical

AVEO Pharmaceuticals, Inc

Bayer AG

BeiGene

Bellberry Limited

BioAtla Inc

Boehringer Ingelheim

Boston Scientific

Breast Cancer Trials (BCT)

Bristol Myers Squibb (BMS)

Cancer Council

Cascadian Therapeutics, Inc

Celgene Corporation

Checkmate Pharmaceuticals, Inc.

Clinical Network Services (CNS) Pty. Ltd

Clinipace

ClinPath Pathology

Clintec

Concord Hospital

Constellation Pharmaceuticals

CSL Limited

CStone Pharmaceuticals

Daiichi Sankyo Company, Limited

Debiopharm Group

DocuSign

DrugDev, Inc.

Eisai Co., Ltd

Eli Lilly and Company

Epworth HealthCare

Eucure (Beijing) Biopharma Co., Ltd

Exelixis, Inc

F. Hoffmann-La Roche AG (Roche)

Five Prime Therapeutics, Inc.

Gallipoli Medical Research Foundation

Genentech, Inc

Genmab A/S

Genomics for Life

Genzyme

George Clinical

Ghent University

Gilead Sciences, Inc.

GlaxoSmithKline plc (GSK plc)

GreenLight Clinical

Hangzhou TigerMed

Hinova Pharmaceuticals Inc

Hobart Pathology

Hutchison MediPharma Limited

ICON plc

Idera Pharmaceuticals, Inc.

I-MED Radiology Network

ImmunoGen, Inc

Immunomedics

INC Research

Incyte Corporation

INmune Bio Inc

IQVIA

Janssen Pharmaceuticals

Jiangsu Hengrui Medicine

Johnson & Johnson

Jones Radiology

Kartos Therapeutics

Karyopharm Therapeutics Inc.

Kazia Therapeutics Limited

Labcorp

Icon is proud to work with over 200 collaborators including Clinical Research Organisations (CROs), commercial and non-commercial organisations (including the pharmaceutical industry, hospitals, and universities), industry vendors and service providers. We understand that making a difference in reducing the global cancer burden is a collaborative effort and we continue to partner with leading organisations to contribute to the future of cancer care.

Laboratoires Servier (Servier)

LaNova Australia Pty Ltd

London Regional Cancer Program

Loxo Oncology, Inc.

Lucence

Lumus Imaging

MacroGenics, Inc

Mater Health

Mater Research

MaxiNovel Pharmaceuticals Co.,Ltd

Medicenna Therapeutics Corp

MedImmune, LLC

Medivation, Inc.

Medpace Holdings, Inc.

Melanoma and Skin Cancer Trials (MASC Trials)

Melbourne Pathology

Merck KGaA

Merck Sharp & Dohme (Australia)

Pty. Ltd (MSD)

Mersana Therapeutics, Inc

Metagone Biotech Inc.

Microba Life Sciences

Millenium Pharmaceuticals

Mirati Therapeutics Inc

Molecule2Market

Monash University

MorphoSys AG

Morphotek, Inc.

Myeloid Therapeutics

Myovant Sciences

Nektar Therapeutics

North Eye Specialists

Novartis AG

Novogen Research Pty Ltd

Novotech (Australia) Pty Limited

Nucleus Network

Olema Oncology Australia Pty Ltd

OncoC4, Inc.

Onconova Therapeutics Inc.

Outlook Eye Centre

Parexel International

Peter MacCallum Cancer Institute

Pfizer, Inc.

Pharmaceutical Product Development, Inc. (PPD)

Pharmaceutical Solutions Limited (PharmaSols)

Pharmacyclics LLC

Pharm-Olam LLC

Pharos I&BT Co., LTD.

PRA Health Sciences

PSI CRO AG

QIMR Berghofer Medical Research Institute

Qscan

Queensland Cardiovascular Group

Queensland Eye Institute

Queensland University of Technology

Queensland X-Ray

RealTime Software Solutions, LLC

Regeneron Pharmaceuticals

Sanofi S.A.

Seagen Inc.

Shanghai Henlius Biotech

Sierra Oncology, Inc.

Sonic HealthCare

South Coast Radiology

Sullivan Nicolaides Pathology

Supportive Therapeutics, LLC

Suzhou Sinovent Pharmaceuticals Co., Ltd. (Sinovent)

Symvivo Corporation

Syneos Health

Takeda Oncology

Telios Pharma, Inc.

Telix Pharmaceuticals

TG Therapeutics, Inc.

Translational Research In Oncology

Translational Research Institute

Trans-Tasman Radiation Oncology Group (TROG)

TrialDocs International Pty Ltd

TriNetX, LLC

Turning Point Therapeutics, Inc.

UnitingCare Health

University of Queensland

University of Sydney

Varian

Worldwide Clinical Trials

Y-mAbs Therapeutics Inc

Ziopharm Oncology, Inc.

PRINCIPAL INVESTIGATORS

MEDICAL ONCOLOGY

Principal Investigator Title

Dr Anas Alawawdeh

MBBS, FRACP

Dr Vladimir Andelkovic MD, FRACP

Dr LeLe Aung

Bsc (USA) MD (USA) MPH (Singapore) Board Certified, Paediatrics & Paediatric Haematology-Oncology (USA)

Dr Carolyn Bampton MBBS, FRACP

Dr Sarwan Bishnoi MBBS, MD, FRACP

Dr Daniel Chan Boon Yeow

MBBS (Hons), MRCP (UK), FAMS (Medical Oncology), FRCP (UK)

Dr Kerry Cheong MBBS (Hons), FRACP

A/Prof Jim Coward

BSc (Hons), MBBS, MRCP (UK), FRACP, PhD

Dr Chun Loo Gan MBBS, MCncrSc, FRACP

A/Prof Jeffrey Goh MBBS (Monash), FRACP

Dr David Grimes MBBS (Qld), FRACP

Dr Amy Hsieh MBBS, FRACP

Dr Hsieh Wen-Son

BSc (USA), MD (USA), Internal Medicine (USA), Medical Oncology (USA), Diplomate Internal Medicine and Medical Oncology ABIM (USA)

Dr Mohammed Islam MBBS, FRACP

Dr Abhishek Joshi MBBS, MD, DM, FRACP

Dr Patricia Kho Sunn Sunn MBBS (UK), FRACP (Australia), MPhil (Sydney)

A/Prof Dusan Kotasek MBBS (Hons), FRACP

Dr Lee Guek Eng BSc, MBBS, MRCP, MMed

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Principal Investigator Title

Dr Robert Lim

MChB, ABIM (Int Med), ABIM (Med Onc), ABIM (Heme), FRCP (Edin)

Dr Agnieszka Malczewski

MBBS, FRACP, MSc

A/Prof Nicole McCarthy

MBBS (Hons), MHSc, FRACP

Dr Anna Mislang

MBBS, FRACP

Dr Cristina Moldovan MBBS, FRACP

Dr Ng Wan Ying Alice

MB BS (HK), FRCR, FHKCR, FHKAM (Radiology)

A/Prof Louise Nott

BMedSci, MBBS (Hons), FRACP

Dr Meena Okera MBBS (Hons), FRACP

Dr Francis Parnis MBBS, FRACP

Dr Dainik Patel

MBBS, FRACP

Dr Nimit Singhal MBBS, FRACP

A/Prof Michael Slancar MD, FRACP

Dr Adam Stirling MBBS (Hons), FRACP

Dr Brian Stein MBBS (Hons), FRACP

Dr Hsiang Tan

MBBS, FRACP

Dr Tan Yew Oo

MBBS, FRCP (Canada), FACP (USA), FRACP (Aus), FRCP (UK), FRCP (Glasg), FAMS (Medical Oncology), Diplomate of American Board of Internal Medicine, Haematology and Medical Oncology

Dr Gonzalo Tapia Rico

MBBS, PhD, FRACP

A/Prof Paul Vasey

MBChB, MSc (Clin.Pharm), MD, MRCP (UK), FRACP

Dr Karmen Wong

MBBS (AUS), MRCP (UK), FRCP (Glasg), MMed (Int Med), FAM

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

Medical Oncologist

PRINCIPAL INVESTIGATORS

HAEMATOLOGY

Principal Investigator Title

Dr Raymond Banh

MBBS, FRACP, FRCPA

Dr Jason Butler

MBBS, M.MED Sci (CLIN EPID), FRACP, FRCPA

Dr Stanley Cheung

MBBS, PhD, MRCP, FRACP, FHKCP, FHKAM, FRCP (Glasg), AFRACMA

Dr Joseph Clarey

MBBS, MClinTRes, FRACP, FRCPA

A/Prof Simon Durrant

MBBS, MRCS, LRCP, FRACP, FRCPath

Dr Paul Eliadis AM

BSc, MBBS, Hon.DLitt (QLD), DUniv Griff., FRACP, FRCPA

Dr Stephen Fanning

MBBS, BSc (Med), FRACP, FRCPA

Dr Robert Hensen

MBBS, FRACP, FRCPA

Dr Matthew Hourigan

MBBS (Hons), FRACP, FRCPA

Dr Ian Irving

MBBS, FRACP, FRCPA, AFRACMA, GAICD

A/Prof James Morton AM

MBBS, BSci (Med), FRACP, FRCPA, GAICD

A/Prof Kerry Taylor

MBBS (Hons), FRACP, FRCPA

Dr Nick Wickham

MA, MRCP, FRCPath, FRACP, FRCPA, GAICD

Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

Medical Oncologist and Clinical Haematologist

Medical Oncologist and Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

Clinical Haematologist

PRINCIPAL INVESTIGATORS

RADIATION MEDICINE

Principal Investigator Title

Mr Trent Aland

BASc, MSc, MBA, PhD in Medical Physics

Dr Patrick Bowden MBBS, FRANZCR

Dr Joanne Castelli

FRANZCR, MBBS (Hons), BSc (Biomed)

Dr Vanessa Estall BHB, MBChB, FRANZCR, MD

Prof Gerald Fogarty BSc, MBBS, PhD, FRANZCR

A/Prof Matthew Foote

BSc, MBBS (Hons), FRANZCR

A/Prof Jim Jackson

MBBS, FRANZCR, PhD

A/Prof Michael Jones

BSc, BE (Hons), MBBS, MPHTM, PhD, FRANZCR

Dr Eric Khoo MBBS, FRANZCR

Dr Andrew Lee FRANZCR, MBBS, B Med Sci (Adv)

Dr Dominic Lunn BSc (Hons), MBBS (Hons), FRANZCR, DipPallMed (Clinical)

Dr Lekshmi Nair MBBS, FRANZCR

Dr Andrew Oar BSc, MBBS, MIPH, FRANZCR

A/Prof Mark Pinkham BM, BCh, MA (Hons)(Oxon), FRANZCR

Dr Andrew See MBBS, FRANZCR

Dr Kevin So MBBS, BMedSc (Hons), FRANZCR

Dr Amy Yuen Meei Teh

BSc (Med), MBBS (Hons), FRANZCR

Dr Vivien Tse

MBBS, MSc, MRCP (UK), FRCR (UK), FRANZCR

Group Director - Medical Physics

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

Radiation Oncologist

2022 PUBLICATIONS

1. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention Ridner SH, Dietrich MS, Boyages J, Koelmeyer L, Elder E, Hughes TM, French J, Ngui N, Hsu J, Abramson VG, Moore A, Shah C. Lymphat Res Biol. 2022 Dec;20(6):618-628. doi: 10.1089/lrb.2021.0084. Epub 2022 Jan 28.

Icon Author: Boyages J

2. A method for time-independent film dosimetry: Can we obtain accurate patient-specific QA results at any time postirradiation? Dunn L, Godwin G, Hellyer J, Xu X. J Appl Clin Med Phys. 2022 Mar;23(3):e13534. doi: 10.1002/acm2.13534. Epub 2022 Jan 20.

Icon Author: Godwin G

3. A new indocyanine green fluorescence lymphography protocol for diagnostic assessment of lower limb lymphoedema Suami H, Thompson B, Mackie H, Blackwell R, Heydon-White A, Blake FT, Boyages J, Koelmeyer L. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):3946-3955. doi: 10.1016/j. bjps.2022.08.017. Epub 2022 Aug 24.

Icon Author: Boyages J

4. A retrospective analysis of the investigative practices of acute limb ischaemia presenting with an unknown aetiology Nath K, Reyaldeen R, Mack K, Sistla L, Palamuthusingam D, Zahir SF, Dave R, Muller J, McCann A. ANZ J Surg. 2022 Mar;92(3):453-460. doi: 10.1111/ans.17265. Epub 2021 Oct 18.

Icon Author: Nath K

5. ACPSEM position paper on the clinical implementation of image registration Archibald-Heeren B. Phys Eng Sci Med. 2022 Jun;45(2):419-420. doi: 10.1007/ s13246-022-01133-3. Epub 2022 Jun 2.

Icon Author: Archibald-Heeren B

6. Acquired HbH disease diagnosed by HbA1c capillary electrophoresis McKeague S, Peake N, Lovelock D, Chow J, Benson R, Fanning S. Br J Haematol. 2022 Dec 14. doi: 10.1111/bjh.18587. Online ahead of print.

Icon Author: Fanning S

7. Activity and outcomes of autologous stem cell transplantation in the private sector in Australia Nath K, James Y, Taylor D, Gardner R, Rai N, Ware RS, Taylor K, Morton J, Durrant S, Irving I, Bashford J. Intern Med J. 2022 Mar 23. doi: 10.1111/imj.15754. Online ahead of print.

Icon Author: Nath K, James Y, Taylor D, Taylor K, Morton J, Durrant S, Irving I, Bashford J

8. An Overview of the Role of Radiotherapy in the Treatment of Small Cell Lung Cancer - A Mainstay of Treatment or a Modality in Decline? Merie R, Gee H, Hau E, Vinod S. Clin Oncol (R Coll Radiol). 2022 Nov;34(11):741-752. doi: 10.1016/j.clon.2022.08.024. Epub 2022 Sep 3.

Icon Author: Merie R

9. Assessment of Toxic Effects and Survival in Treatment Deescalation With Radiotherapy vs Transoral Surgery for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: The ORATOR2 Phase 2 Randomized Clinical Trial Palma DA, Prisman E, Berthelet E, Tran E, Hamilton S, Wu J, Eskander A, Higgins K, Karam I, Poon I, Husain Z, Enepekides D, Hier M, Sultanem K, Richardson K, Mlynarek A, Johnson-Obaseki S, Odell

M, Bayley A, Dowthwaite S, Jackson JE, Dzienis M, O’Neil J, Chandarana S, Banerjee R, Hart R, Chung

J, Tenenholtz T, Krishnan S, Le H, Yoo J, Mendez A, Winquist E, Kuruvilla S, Stewart P, Warner A, Mitchell S, Chen J, Parker C, Wehrli B, Kwan K, Theurer J, Sathya J, Hammond JA, Read N, Venkatesan V, MacNeil SD, Fung K, Nichols AC. JAMA Oncol. 2022 Jun 1;8(6):1-7. doi: 10.1001/jamaoncol.2022.0615.

Icon Author: Jackson JE

Barriers and enablers of weight management after breast cancer: a thematic analysis of free text survey responses using the COM-B model Ee C, MacMillan F, Boyages J, McBride K. BMC Public Health. 2022 Aug 20;22(1):1587. doi: 10.1186/s12889-022-13980-6.

Icon Author: Boyages J

10. Can We Compare the Health-Related Quality of Life of Childhood Cancer Survivors Following Photon and Proton Radiation Therapy? A Systematic Review Doig M, Bezak E, Parange N, Gorayski P, Bedford V, Short M. Cancers (Basel). 2022 Aug 15;14(16):3937. doi: 10.3390/cancers14163937.

Icon Author: Gorayski P

11. Characterisation of in-room leakage and scattered radiation for the Varian Halcyon linear accelerator Caravani K, Murry R, Healy B. Phys Eng Sci Med. 2022 Mar;45(1):73-81. doi: 10.1007/s13246-021-01084-1.

Epub 2021 Nov 19.

Icon Author: Healy B

12. Characterization of an advanced cone beam CT (CBCT) reconstruction algorithm used for dose calculation on Varian Halcyon linear accelerators Hu Y, Arnesen M, Aland T. Biomed Phys Eng Express. 2022 Feb 25;8(2). doi: 10.1088/2057-1976/ac536b.

Icon Author: Aland T

13. Clinical and molecular characteristics of ARIEL3 patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian carcinoma O’Malley DM, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Colombo N, Weberpals JI, Clamp AR, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, Swisher EM, Maloney L, Goble S, Lin KK, Kwan T, Ledermann JA, Coleman RL. Gynecol Oncol. 2022 Dec;167(3):404-413. doi: 10.1016/j. ygyno.2022.08.021. Epub 2022 Oct 20.

Icon Author: Goh JC

14. Clinical best practices in optimal monitoring, early diagnosis, and effective management of antibodydrug conjugate-induced interstitial lung disease or pneumonitis: a multidisciplinary team approach in

Singapore Yong WP, Teo FS, Teo LL, Ng MC, Tan TJ, Low SY, Wong K, Ang P, Choo SP, Lee KH, Lee SC. Expert Opin Drug Metab Toxicol. 2022 Dec;18(12):805-815. doi: 10.1080/17425255.2022.2162383. Epub 2023 Jan 12.

Icon Author: Wong K

15. Communication and collaboration skills training in Radiation Oncology in Australia and New Zealand: A qualitative study Levy DC, Naehrig D, Sullivan L, Chin YS. Asia Pac J Clin Oncol. 2022 Oct;18(5):e356-e362. doi: 10.1111/ajco.13736. Epub 2022 Jan 18.

Icon Author: Sullivan L

16. COVID-19 Vaccine Hesitancy in Australian Patients with Solid Organ Cancers Bain N, Nguyen M, Grech L, Day D, McCartney A, Webber K, Kwok A, Harris S, Chau H, Chan B, Nott L, Hamad N, Tognela A, Underhill C, Loe BS, Freeman D, Segelov E, On Behalf Of The Canvaccs Investigators. Vaccines (Basel). 2022 Aug 23;10(9):1373. doi: 10.3390/vaccines10091373.

Icon Author: Nott L, Bain N

17. Current status of intra-cranial stereotactic radiotherapy and stereotactic radiosurgery in Australia and New Zealand: key considerations from a workshop and surveys Pudsey L, Haworth A, White P, Moutrie Z, Jonker B, Foote M, Poder J. Phys Eng Sci Med. 2022 Mar;45(1):251-259. doi: 10.1007/s13246-022-011084. Epub 2022 Feb 3.

Icon Author: Foote M

18. Cutaneous squamous cell carcinoma metastatic to the axilla and groin: Outcomes and prognostic factors Bucknell NW, Gyorki DE, Bressel M, Estall V, Webb A, Henderson M, Chua MS, Rischin D, Tiong A. Australas J Dermatol. 2022 Feb;63(1):43-52. doi: 10.1111/ ajd.13739. Epub 2021 Nov 9.

Icon Author: Bucknell NW, Estall V

19. Disseminated enterovirus infection in a patient treated with obinutuzumab McNeil T, Hannah R, Hui CH, Qiao M. J Med Virol. 2022 Feb;94(2):439-441. doi: 10.1002/ jmv.27370. Epub 2021 Oct 6.

Icon Author: Hui CH

20. Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial See AW, Bowden P, Wells G, Appu S, Lawrentschuk N, Liodakis P, Pandeli C, Aarons Y, Smyth LML, McKenzie DP. Radiat Oncol. 2022 Jul 25;17(1):131. doi: 10.1186/s13014022-02103-5.

Icon Author: See AW, Bowden P, Pandeli C, Aarons Y, Smyth LML

21. Evaluation of HyperArc™ using film and portal dosimetry quality assurance Kamst O, Desai P. Phys Eng Sci Med. 2022 Dec 1. doi: 10.1007/s13246-02201197-1. Online ahead of print.

Icon Author: Kamst O, Desai P

22. From Postoperative to Preoperative: A Case Series of Hypofractionated and Single-Fraction Neoadjuvant Stereotactic Radiosurgery for Brain Metastases

Udovicich C, Ng SP, Tange D, Bailey N, Haghighi N. Oper Neurosurg (Hagerstown). 2022 Apr 1;22(4):208-214. doi: 10.1227/ONS.0000000000000101.

Icon Author: Haghighi N, Bailey N

23. Genomic Landscape of Non-Small Cell Lung Cancer (NSCLC) in East Asia Using Circulating Tumor DNA (ctDNA) in Clinical Practice Cho BC, Loong HHF, Tsai CM, Teo MLP, Kim HR, Lim SM, Jain S, Olsen S, Park K. Curr Oncol. 2022 Mar 21;29(3):2154-2164. doi: 10.3390/ curroncol29030174.

Icon Author: Teo MLP

24. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study Motzer R, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Bennett L, Wang J, Pan JJ, Saretsky TL, Perini RF, He CS, Mody K, Cella D. Lancet Oncol. 2022 Jun;23(6):768-780. doi: 10.1016/S14702045(22)00212-1. Epub 2022 Apr 27.

Icon Author: Goh JC

25. How Can Genomic Innovations in Pediatric Brain Tumors Transform Outcomes in Low- and Middle-Income Countries? Bailey S, Davidson A, Parkes J, Tabori U, Figaji A, Epari S, Chinnaswamy G, Dias-Coronado R, CasavilcaZambrano S, Amayiri N, Vassal G, Bouffet E, Clifford SC. JCO Glob Oncol. 2022 Oct;8:e2200156. doi: 10.1200/ GO.22.00156.

Icon Author: Parkes J

26. Immunotherapy for the treatment of perineural spread in cutaneous head and neck squamous cell carcinoma: Time to rethink treatment paradigms Nightingale J, Gandhi M, Helena J, Bowman J, McGrath M, Coward J, Ladwa R, Panizza B. Head Neck. 2022 May;44(5):1099-1105. doi: 10.1002/hed.27005. Epub 2022 Feb 13.

Icon Author: Coward J

27. Insensitivity of machine log files to MLC leaf backlash and effect of MLC backlash on clinical dynamic MLC motion: An experimental investigation Barnes M, Pomare D, Doebrich M, Standen TS, Wolf J, Greer P, Simpson J. J Appl Clin Med Phys. 2022 Sep;23(9):e13660. doi: 10.1002/acm2.13660. Epub 2022 Jun 9.

Icon Author: Wolf J

28. Investigation of dose profile across the junction of deep inspiration breath hold, breast with supra-clavicle fossa treatments Barr S, Mulherin D, Walsh A, Spalding M. Med Dosim. 2022 Autumn;47(3):227-235. doi: 10.1016/j. meddos.2022.03.004. Epub 2022 May 3.

Icon Author: Walsh A

29. Nivolumab plus rucaparib for metastatic castrationresistant prostate cancer: results from the phase 2 CheckMate 9KD trial Fizazi K, Retz M, Petrylak DP, Goh JC, Perez-Gracia J, Lacombe L, Zschäbitz S, Burotto M, Mahammedi H, Gravis G, Bastos DA, McCune SL, Vázquez Limón JC, Kwan EM, Castellano D, Fléchon A, Saad F, Grimm MO, Shaffer DR, Armstrong AJ, Bhagavatheeswaran P, Amin NP, Ünsal-Kaçmaz K, Wang X, Li J, Loehr A, Pachynski RK. J Immunother Cancer. 2022 Aug;10(8):e004761. doi: 10.1136/jitc-2022-004761.

Icon Author: Goh JC

30. Oncology During the COVID-19 Pandemic: a Lockdown Perspective Boniface D, Tapia-Rico G. Curr Oncol Rep. 2022 Oct;24(10):1219-1235. doi: 10.1007/s11912-02201301-4. Epub 2022 May 27.

Icon Author: Tapia-Rico G

2022 PUBLICATIONS

CONTINUED

31. Outcomes Following Hypofractionated Stereotactic Radiotherapy to the Cavity After Surgery for Melanoma

Brain Metastases Gallo J, Garimall S, Shanker M, Castelli J, Watkins T, Olson S, Huo M, Foote MC, Pinkham MB. Clin Oncol (R Coll Radiol). 2022 Mar;34(3):179-186. doi: 10.1016/j.clon.2021.09.015.

Epub 2021 Oct 9.

Icon Author: Castelli J, Huo M, Foote MC, Pinkham MB

32. Palbociclib plus letrozole as treatment for postmenopausal women with hormone receptorpositive/human epidermal growth factor receptor 2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate: An expanded access study in Australia and India Loi S, Karapetis CS, McCarthy N, Oakman C, Redfern A, White M, Khasraw M, Doval DC, Gore V, Alam M, Binko J, Lu DR, Kim S, Boyle F. Asia Pac J Clin Oncol. 2022 Dec;18(6):560-569. doi: 10.1111/ajco.13653. Epub 2021 Dec 14.

Icon Author: McCarthy N

33. Patient-derived xenograft models capture genomic heterogeneity in endometrial cancer Bonazzi VF, Kondrashova O, Smith D, Nones K, Sengal AT, Ju R, Packer LM, Koufariotis LT, Kazakoff SH, Davidson AL, Ramarao-Milne P, Lakis V, Newell F, Rogers R, Davies C, Nicklin J, Garrett A, Chetty N, Perrin L, Pearson JV, Patch AM, Waddell N, Pollock PM. Genome Med. 2022 Jan 10;14(1):3. doi: 10.1186/s13073-021-00990-z.

Icon Author: Nicklin J, Garrett A

34. Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1 Saad F, de Bono J, Barthélémy P, Dorff T, Mehra N, Scagliotti G, Stirling A, Machiels JP, Renard V, Maruzzo M, Higano CS, Gurney H, Healy C, Bhattacharyya H, Arondekar B, Niyazov A, Fizazi K. Eur Urol. 2022 Jun 21:S0302-2838(22)02407-1. doi: 10.1016/j.eururo.2022.05.030. Online ahead of print.

Icon Author: Stirling A

35. Patterns of curative treatment for non-small cell lung cancer in New South Wales, Australia Batumalai V, Descallar J, Gabriel G, Delaney GP, Oar A, Barton MB, Vinod SK. Asia Pac J Clin Oncol. 2022 Jul 17. doi: 10.1111/ajco.13811. Online ahead of print.

Icon Author: Oar A

36. Penpulimab, an anti-PD1 IgG1 antibody in the treatment of advanced or metastatic upper gastrointestinal cancers Zheng Y, Mislang ARA, Coward J, Cosman R, Cooper A, Underhill C, Zhu J, Xiong J, Jiang O, Wang H, Xie Y, Zhou Y, Jin X, Li B, Wang ZM, Kwek KY, Xia D, Xia Y, Xu N. Cancer Immunol Immunother. 2022 Oct;71(10):2371-2379. doi: 10.1007/s00262-02203160-1. Epub 2022 Feb 15.

Icon Author: Coward J, Mislang ARA

37. Planned withdrawal of dexamethasone after pomalidomide low-dose dexamethasone induction for lenalidomide-refractory multiple myeloma (ALLG MM14) Kalff A, Khong T, Ramachandran M, Ho PJ, Mollee P, D’Rozario J, Taylor K, Estell J, Norton S, Kemp R, Mitchell AJ, Reynolds J, Kennedy N, Quach H, Spencer A. Haematologica. 2022 Jan 1;107(1):321325. doi: 10.3324/haematol.2021.278655.

Icon Author: Taylor K

38. Practical management of chronic lymphocytic leukemia with acalabrutinib Kuss B, Nagarajan C, Hsieh WS, Cheah CY. Leuk Lymphoma. 2022 Dec;63(12):2785-2794. doi: 10.1080/10428194.2022.2098289. Epub 2022 Jul 19.

Icon Author: Hsieh WS

39. Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes Dietrich MS, Gaitatzis K, Koelmeyer L, Boyages J, Abramson VG, McLaughlin SA, Ngui N, Elder E, French J, Hsu J, Hughes TM, Stolldorf DP, Shah C, Ridner SH. Lymphat Res Biol. 2022 Sep 20. doi: 10.1089/lrb.2022.0020. Online ahead of print.

Icon Author: Boyages J

40. Radiotherapy prioritization in 143 national cancer control plans: Correlation with radiotherapy machine availability, geography and income level Wilson BE, Oar A, Rodin D, Bray F, Ferlay J, Polo A, Borras JM, Bourque JM, Malik M, Ynoe de Moraes F, Lievens Y, Stevens LM, Zubizarreta E, Yap ML. Radiother Oncol. 2022 Nov;176:83-91. doi: 10.1016/j.radonc.2022.09.001. Epub 2022 Sep 14.

Icon Author: Oar A

41. Real-world outcomes from use of CDK4/6 inhibitors in the management of advanced/ metastatic breast cancer in Asia Low JL, Lim E, Bharwani L, Wong A, Wong K, Ow S, Lim SE, Lee M, Choo J, Lim J, Chan G, Walsh RJ, Muthu V, Ngoi N, Chong W, Tan SH, Lee SC. Ther Adv Med Oncol. 2022 Dec 18;14:17588359221139678. doi: 10.1177/17588359221139678. eCollection 2022.

Icon Author: Wong K

42. Recommended testing algorithms for NTRK gene fusions in pediatric and selected adult cancers: Consensus of a Singapore Task Force Lim KHT, Kong HL, Chang KTE, Tan DSW, Tan IBH, Mohamad F, Soh SY, Pang BN, Soo RA, Choo SP, Hsieh WS, Aung L. Asia Pac J Clin Oncol. 2022 Aug;18(4):394-403. doi: 10.1111/ ajco.13727. Epub 2021 Nov 21.

Icon Author: Kong HL, Hsieh WS, Aung L

43. Results of PD-L1 Analysis of Women Treated with Durvalumab in Advanced Endometrial Carcinoma (PHAEDRA) Smith D, Robledo KP, Yip S, Cummins MM, Kok PS, Lee YC, Friedlander M, Baron-Hay S, Shannon

C, Coward J, Beale P, Goss G, Meniawy T, Lombard J, Spurdle AB, Andrews J, Stockler MR, Mileshkin L, Antill Y; Australia New Zealand Gynaecological Oncology Group (ANZGOG). Cancers (Basel). 2022 Dec 30;15(1):254. doi: 10.3390/cancers15010254.

Icon Author: Coward J

44. Risk factors for breast cancer-related lymphedema in patients undergoing 3 years of prospective surveillance with intervention Koelmeyer LA, Gaitatzis K, Dietrich MS, Shah CS, Boyages J, McLaughlin SA, Taback B, Stolldorf DP, Elder E, Hughes TM, French JR, Ngui N, Hsu JM, Moore A, Ridner SH. Cancer. 2022 Sep 15;128(18):3408-3415. doi: 10.1002/cncr.34377. Epub 2022 Jul 7.

Icon Author: Boyages J

45. Serious Underlying Medical Conditions and COVID-19 Vaccine Hesitancy: A Large Cross-Sectional Analysis from Australia Day D, Grech L, Nguyen M, Bain N, Kwok A, Harris S, Chau H, Chan B, Blennerhassett R, Nott L, Hamad N, Tognela A, Hoffman D, McCartney A, Webber K, Wong J, Underhill C, Sillars B, Winkel A, Savage M, Loe BS, Freeman D, Segelov E, On Behalf Of The Canvaccs Diabvaccs And Msvaccs Investigators. Vaccines (Basel). 2022 May 26;10(6):851. doi: 10.3390/ vaccines10060851.

Icon Author: Nott L, Bain N

46. Spontaneous tumour lysis syndrome complicated by recurrent hypoglycaemia in first presentation of advanced lymphoproliferative disease Head LV, Hancock M, Armitage MC. Emerg Med Australas. 2022 Aug;34(4):658-659. doi: 10.1111/1742-6723.14031.

Epub 2022 Jun 4.

Icon Author: Hancock M

47. Survey of germline variants in cancer-associated genes in young adults with colorectal cancer Mikaeel RR, Young JP, Li Y, Smith E, Horsnell M, Uylaki W, Tapia Rico G, Poplawski NK, Hardingham JE, Tomita Y, Townsend AR, Feng J, Zibat A, Kaulfuß S, Müller C, Yigit G, Wollnik B, Price TJ. Genes Chromosomes Cancer. 2022 Feb;61(2):105-113. doi: 10.1002/gcc.23011. Epub 2021 Nov 18.

Icon Author: Tapia Rico G

48. Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1

Safety Analyses Mehra N, Fizazi K, de Bono JS, Barthélémy P, Dorff T, Stirling A, Machiels JP, Bimbatti D, Kilari D, Dumez H, Buttigliero C, van Oort IM, Castro E, Chen HC, Di Santo N, DeAnnuntis L, Healy CG, Scagliotti GV. Oncologist. 2022 Oct 1;27(10):e783-e795. doi: 10.1093/oncolo/oyac172.

Icon Author: Stirling A

49. The optimal management of brain metastases from gestational trophoblastic neoplasia Tsai J, Vellayappan B, Venur V, McGranahan T, Gray H, Urban RR, Tseng YD, Palmer J, Foote M, Mayr NA, Combs SE, Sahgal A, Chang EL, Lo SS. Expert Rev Anticancer Ther. 2022 Mar;22(3):307-315. doi: 10.1080/14737140.2022.2038566. Epub 2022 Feb 13.

Icon Author: Foote M

50. The Utility of the Oncotype DX Test for Breast Cancer Patients in an Australian Multidisciplinary Setting Choi JDW, Hughes TMD, Marx G, Boyages J, Rutovitz J, Hasovits C, Parasyn A, Edirimanne S, Ngui NK. Breast J. 2022 Jan 31;2022:1199245. doi: 10.1155/2022/1199245. eCollection 2022.

Icon Author: Boyages J

51. Variability of gross tumour volume delineation: MRI and CT based tumour and lymph node delineation for lung radiotherapy Kumar S, Holloway L, Boxer M, Yap ML, Chlap P, Moses D, Vinod S. Radiother Oncol. 2022 Feb;167:292-299. doi: 10.1016/j.radonc.2021.11.036.

Epub 2021 Dec 8.

Icon Author: Boxer M

52. Varian ethos online adaptive radiotherapy for prostate cancer: Early results of contouring accuracy, treatment plan quality, and treatment time Byrne M, ArchibaldHeeren B, Hu Y, Teh A, Beserminji R, Cai E, Liu G, Yates A, Rijken J, Collett N, Aland T. J Appl Clin Med Phys. 2022 Jan;23(1):e13479. doi: 10.1002/acm2.13479. Epub 2021 Nov 29.

Icon Author: Byrne M, Archibald-Heeren B, Hu Y, Teh A, Beserminji R, Cai E, Liu G, Yates A, Rijken J, Collett N, Aland T

53. Weight Gain and Lymphedema After Breast Cancer Treatment: Avoiding the Catch-22? Boyages J, Cave AE, Naidoo D, Ee CCL. Lymphat Res Biol. 2022 Aug;20(4):409-416. doi: 10.1089/lrb.2020.0048. Epub 2021 Nov 8.

Icon Author: Boyages J

54. What Asian-Pacific Countries Could Build Upon the United States’ Oncology Care Model? Chen J, Wee S, Sally Ho SL. JCO Oncol Pract. 2022 Jan;18(1):1-3. doi: 10.1200/OP.21.00367. Epub 2021 Aug 2.

Icon Author: Wee S

TRIALS REGISTER 2022

MEDICAL ONCOLOGY

Abbrev. Title Protocol Title

1403-0008 Brightline-1

A Phase II/III, Randomized, Open-label, Multi-center Study of BI 907828 compared to Doxorubicin as First Line Treatment of Patients with Advanced Dedifferentiated Liposarcoma

20190135 CodeBreak 101 A Phase 1b/2, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination with Other Anti-cancer Therapies in Subjects with Advanced Solid Tumours with KRAS p.G12C Mutation (CodeBreak 101)

20-214-29 CA045-22

PIVOT-12

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

213410 COSTAR Lung

A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy

67652000PCR3002

AMPLITUDE

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

67652000PCR3002

AMPLITUDE

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

ABSK043-101

A Phase 1, Open-Label Study of ABSK043 to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced Solid Tumour

AD206-1001

A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects with Advanced/Metastatic Solid Tumors

ADG116-1003

A Phase 1b, Open-Label, Dose Escalation and Expansion Study of ADG116, ADG116 Combined with Toripalimab (Anti-PD-1 Antibody), ADG116 Combined with ADG106 (AntiCD137 Antibody) in Patients with Advanced/Metastatic Solid Tumours

OPEN TO RECRUITMENT — AUSTRALIA & NEW ZEALAND

MEDICAL ONCOLOGY

Abbrev. Title

AK112-101

Protocol Title

A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects with Advanced Solid Tumours

AK112-101

A Phase 1/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects with Select Advanced Solid Tumours

AK114-102

A Phase 1a, Multicentre, Open Label, Dose-escalating Study to Evaluate the Safety, Pharmacokinetics and Anti Tumour Activity of AK114 in Subjects with Advanced or Metastatic Solid Tumours

AK127-101

A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK127 in Combination with AK104 in Subjects with Advanced or Metastatic Solid Tumours

AL-DES-01 RINGSIDE A Phase 2/3, Randomised, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumours

ANZUP1801 DASL-HiCaP

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

ANZUP1801 DASL-HiCaP Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

ANZUP1802 UniCAB A Phase II Trial of Single Agent Cabozantinib in Patients with Locally Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma Post Immunotherapy or who are Unsuitable for Immunotherapy

AT148003 ASPEN-03 A Phase 2 Study of Evorpacept (ALX148) in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma

AT148004 ASPEN-04 A Phase 2 Study of Evorpacept (ALX148) in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma

MEDICAL ONCOLOGY

Abbrev. Title

Protocol Title

ATG-018-001 ATRIUM A Phase I, Open-Label, Multi-Center, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies

BAY 88-8223 20510 RADIANT

A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients with Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH

BAY 88-8223 20510 RADIANT

A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients with Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH

BCT 1901 CAPTURE A Phase 2 Randomised Study to Evaluate Apelisib plus Fulvestrant Versus Capecitabine in Oestrogen Receptor Positive, HER2-Negative Advanced Breast Cancer Patients with PIK3CA Mutant Circulating DNA

BGB-900-105

AdvanTIG-105

Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumours

BGB-900-105

AdvanTIG-105

Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

BGB-A317-15025-101 A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB 15025 alone and in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumours

BGB-A317-290-LTE1 An Open-Label, Multicenter, Long-term Extension Study of Tislelizumab-Containing Treatment and/or Pamiparib-Containing Treatment in Patients with Advanced Malignancies

BGB-A317-B167-101 A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

MEDICAL ONCOLOGY

OPEN

TO RECRUITMENT — AUSTRALIA

& NEW ZEALAND

Abbrev. Title

BGB-A317-LBL-007-201

Protocol Title

A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Therapy in Patients With Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer

BIG 16-05 AFT-27

WO39391 IMPassion030

Alexandra

A Phase 3, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination with Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients with Operable Triple Negative

Breast Cancer

BIG 16-05 AFT-27

WO39391 IMPassion030

Alexandra

TRIALS REGISTER MEDICAL ONCOLOGY TRIALSOPEN TO RECRUITMENT

BIG 19-02 BCT2002 DECRESCENDO

BIG 19-02 BCT2002 DECRESCENDO

BO29554 B.FAST

A Phase 3, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination with Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients with Operable Triple Negative

Breast Cancer

De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade

De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade

A Phase 2/3 Multicentre Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harbouring Actionable Somatic Mutations Detected in Blood

CA224-104 RELATIVITY A Phase 2 Randomized Double-Blind Study of Relatlimab plus Nivolumab in Combination with Chemotherapy Vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

CK-301-101 A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects with Advanced Cancers

CL001_559

A Phase 1 First In Human, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of CCX559 in Subjects with Solid Tumours

MEDICAL ONCOLOGY

OPEN TO RECRUITMENT — AUSTRALIA & NEW ZEALAND

Abbrev. Title

CS5001-101

Protocol Title

A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients with Advanced Solid Tumors and Lymphomas

CTC 0231 ALTG18 001 DREAM3R

Durvalumab (MEDI4736) with Chemotherapy as First Line Treatment in Advanced Pleural Mesothelioma - a Phase 3 Randomised Trial

CYH33-G102

Open Label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of CYH33, an Oral PI3K Inhibitor in Combination with Olaparib, an Oral PARP Inhibitor in Patients with Advanced Solid Tumours

D361EC00001 CAPItello-280

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer

D9670C00001 DESTINYBreast06

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease H as Progressed on Endocrine Therapy in the Metastatic Setting

D9673C00007 DESTINYBreast12

An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients with or Without Baseline Brain Metastasis with Previously Treated Advanced/ Metastatic HER2-Positive Breast Cancer

DB-1303-O-1001

A Phase 1/2a, Multicenter, Open-Label, Non-Randomized First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303 in Patients with Advanced/Metastatic Solid Tumours

ePAD Prostate Electronic CRPC Australian Database (ePAD): Analyzing Treatment Patterns and Outcomes from Real-World Patients with Castrate-Resistant Prostate Cancer (CRPC)

GO42784 TRIO045 lidERA A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

GO42784 TRIO045 lidERA A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

MEDICAL ONCOLOGY

OPEN TO RECRUITMENT — AUSTRALIA & NEW ZEALAND

Abbrev. Title

GO42784 TRIO045 lidERA

Protocol Title

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

GS-US-576-6220 EVOKE-02

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

GS-US-577-6153 EVOKE-01

Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan versus Docetaxel in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Progression On or After Platinum-Based Chemotherapy and Anti-PD-1 / PD-L1 Immunotherapy

GS-US-592-6173 ASCENT 04

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients with Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumours Express PD-L1

GS-US-592-6238 ASCENT 03 A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients with Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumours Do Not Express PD-L1 or in Patients Previously Treated with Anti-PD-(L)1 Agents in the Early Setting Whose Tumours Do Express PD-L1

HBI-8000-303

A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined with Nivolumab Versus Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors

I3Y-MC-JPEG CYCLONE 3 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone Plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer

I3Y-MC-JPEG CYCLONE 3 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone Plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer

I3Y-MC-JPEG CYCLONE 4 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone Plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer

MEDICAL ONCOLOGY

OPEN TO RECRUITMENT — AUSTRALIA & NEW ZEALAND

Abbrev. Title

Protocol Title

iTestis WEHI Bioinformatics for Testis Cancer Database

KRAB Kidney Cancer Australian Registry and Biobank

LM108-01-101

A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Anti-PD-1 Antibody in Subjects with Advanced Solid Tumours

MASC 03.18 I-MAT

A Randomised Placebo-Controlled Phase II Trial of Adjuvant Avelumab in Early Stage Merkel Cell Carcinoma

MAX-10181-001

A Phase I Study of MAX-10181 Given Orally to Patients with Advanced Solid Tumour

MER-XMT-1536-1 UP-LIFT A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumours Likely to Express NaPi2b

MER-XMT-1536-3 UPNEXT A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants with Recurrent, Platinum-Sensitive, Ovarian Cancer

MG010-001 SUCCEED A Phase II, Two-Arm, Open Label, Randomised, Multi-Centre Study to Assess the Safety, Tolerability and Efficacy of MG010 in Combination with Sorafenib in Subjects with Solid Tumours who Have Failed Existing Treatments

MK-3475-867

Keynote-867

MK-7684A-006

Keyvibe-006

A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer

Open Label Phase 3 Study MK7684A (Coformulation of MK-7684 200mg and Pembrolizumab 200 mg) in Combination with CCRT followed by MK7684A Vs CCRT followed by Durvalumab in Participants with Unresectable, Locally-Advanced, Stage III NSCLC (All-Comers Regardless of PD-L1 Status)

MEDICAL ONCOLOGY

OPEN TO RECRUITMENT — AUSTRALIA & NEW ZEALAND

Abbrev. Title

MS100070_0119 JAVELIN Bladder Medley

Protocol Title

A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination with Other Anti-Tumor Agents as a Maintenance Treatment in Participants with Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress with First Line Platinum-Containing Chemotherapy

OP-1250-001

A Phase 1/2 Open-label, First-in-Human, Multicenter, Dose Escalation and Dose Expansion Study of OP-1250 Monotherapy in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

OP-1250-002

A Phase 1/2 Open-label, First-in-Human, Multicenter, Dose Escalation and Dose Expansion Study of OP-1250 Monotherapy in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

OP-1250-002

A Phase 1/2 Open-label, First-in-Human, Multicenter, Dose Escalation and Dose Expansion Study of OP-1250 Monotherapy in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-Positive, HER2-negative Breast Cancer

R2810-ONC-1788 C-POST A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo After Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma

R2810-ONC-1788 C-POST A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo After Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma

R3767-ONC-2011 HARMONY

A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Real-PRO

Registry-Based Study of Enzalutamide Vs Abiraterone assessing Cognitive Function in Elderly Metastatic Castration-Resistant Prostate Cancer

RLY-4008-101 REFOCUS A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumours

SHR2002-102

A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection in Combination with SHR-1316 in Patients with Advanced Malignant Tumours

MEDICAL ONCOLOGY

OPEN TO RECRUITMENT — AUSTRALIA & NEW ZEALAND

Abbrev. Title

SHR3162-III-305 FUZOPRO

Protocol Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic CastrationResistant Prostate Cancer

TQB2928-I-01

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TQB2928 Injection in Patients with Advanced Solid Tumours or Hematological Malignancies

TRIO045 GO42784 ADE liDERA

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

TRIO045 GO42784 HOB liDERA

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

TRIO045 GO42784 WES liDERA

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

XL092-001 STELLAR-001

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors

XL184-315 CONTACT-02

A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab Vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer

ABCPro

Patient Reported Outcome Measures for Individualized Symptom Evaluation and Management in Advanced Breast Cancer

MEDICAL ONCOLOGY

Abbrev. Title

Protocol Title

849-010 KRYSTAL-10 Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation

849-012 KRYSTAL-12 A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation

CELC-G-301 VIKTORIA-1 A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy

D9670C00001 DESTINYBreast06 A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease H as Progressed on Endocrine Therapy in the Metastatic Setting

DS1602-A-U301 TROPION-LUNG01

Phase 3 Randomized Study of DS-1062A versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations

HERTHENA–Lung02 A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus PlatinumBased Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-Mutated (EGFRm) Non-Small Cell Lung Cancer (NSCLC) After Failure of EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

R1979-ONC-1625 ELM-2 An Open-Label Study to Assess the Anti-Tumour Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-cell NonHodgkin Lymphoma

XL092-303 STELLAR-303 A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

17-214-09 CA045002

PIVOT9

Protocol Title

A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined with Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients with Previously Untreated Advanced Renal Cell Carcinoma

17777 1841788 ARASENS A Randomized, Double–Blind, Placebo–Controlled Phase III Study of Darolutamide (ODM–201) versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients with Metastatic Hormone–Sensitive Prostate Cancer

18-214-10 CA045-012

PIVOT-10

A Phase 2, Randomized, Non-Comparative, Open-Label Study of NKTR-214 in Combination with Nivolumab and of Chemotherapy in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients with Low PD-L1 Expression

2019-013-GLOB1

FRESCO-2

A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial to Compare the Efficacy and Safety of Fruquintinib plus Best Supportive Care to Placebo plus Best Supportive Care in Patients with Refractory Metastatic Colorectal Cancer

20321 Darolutamide ROS An Open-Label, Single Arm, Roll-Over Study to Provide Continued Treatment with Darolutamide in Participants who Were Enrolled in Previous Bayer-Sponsored Studies

2125-MEL-301 Illuminate-301

213410 COSTAR Lung

A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with PD 1 Refractory Melanoma

A Randomized, Open-Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants with Advanced Nonsmall Cell Lung Cancer who Have Progressed On Prior Anti-Pd-(L)1 Therapy and Chemotherapy

42756493CAN2002 Ragnar A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumours and FGFR Gene Alterations

56021927PCR3001 ACIS A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

64091742PCR0002 PREVALENCE

Biomarker Study to Determine Frequency of DNA-repair Defects in Men with Metastatic Prostate Cancer

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

9785-CL-0123

Protocol Title

A Phase 2 Open-Label Extension Study for Subjects with Prostate Cancer who Previously Participated in An Enzalutamide Clinical Study

A5481008 TRIO22

A Randomized, Multicenter, Double-Blind Phase 3 Study of PD-0332991 (Oral CDK 4/6 Inhibitor) plus Letrozole versus Placebo plus Letrozole for the Treatment of Postmenopausal Women with ER (+), HER2 (-) Breast Cancer who Have Not Received Any Prior Systemic Anti-Cancer Treatment for Advanced Disease

A5481023 PALOMA3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (Faslodex(R)) With or Without PD-0332991 (Palbociclib) Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy

AB154CSP0001

A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants with Advanced Malignancies

ACT001-AU-004

A Phase 2, Open Label, Multicentre Study Assessing the Safety and Efficacy of ACT001 in Combination with Whole Brain Radiation Therapy (WBRT) for Brain Metastases from Solid Tumours

AK104-101

A Phase 1A/1B Multicenter, Open-Label, Dose-Escalation, and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK104 in Subjects with Advanced Solid Tumours

AK104-201-AU

A Single-Arm, Open-Label, Global, Multicenter, Phase 2 Study to Evaluate the Efficacy of AK104 in Patients with Recurrent or Metastatic Cervical Cancer

AK104-201-AU

A Phase 2, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of AK104 in Subjects with Recurrent or Metastatic Cervical Cancer

AK105-101

A Phase 1A/1B Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects with Advanced Solid Tumours

AK105-101

A Phase 1A/1B Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects with Advanced Solid Tumours

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

AK117-101

Protocol Title

A Phase 1 Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination with AK104 in Subjects with Relapsed/Refractory Advanced or Metastatic Solid Tumours or Lymphomas

AK117-101

A Phase 1 Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination with AK104 in Subjects with Relapsed/Refractory Advanced or Metastatic Solid Tumours or Lymphomas

AK119-102 A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 in Combination with AK104 in Subjects with Advanced or Metastatic Solid Tumours

AK119-102 A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 in Combination with AK104 in Subjects with Advanced or Metastatic Solid Tumours

ANZ1701 AFT-38 PATINA A Randomized, Open Label, Phase 3 Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

ANZGOG1601 PHAEDRA A Phase II Trial of Durvalumab (MEDI4736) in Advanced Endometrial Cancer

ANZUP1303 ENZARAD Randomised Phase 3 Trial of Enzalutamide in Androgen Deprivation Therapy with Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

ANZUP1304 ENZAMET Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

ANZUP1601 KEYPAD A Phase 2 Trial of Pembrolizumab and Denosumab in Advanced Clear-Cell Renal Cell Carcinoma (CCRCC) Progressing After a VEGF-TKI

ANZUP1602 UNISoN Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

ANZUP1907

Protocol Title

RetrospectivePSMA: a Retrospective Study to Identify Clinical Predictors of Early Metastatic Disease Using PSMA PET Imaging

B9991001 JAVELIN100 A Phase 3, Multicenter, Multinational, Randomized, Open-Label, Parallel-Arm Study, of Avelumab (MSB0010718C) plus Best Supportive Care versus Best Supportive Care Alone as a Maintenance Treatment in Patients with Locally Advanced or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion of Frist-Line PlatinumContaining Chemotherapy

B9991001 JAVELIN100 A Phase 3, Multicenter, Multinational, Randomized, Open-Label, Parallel-Arm Study, of Avelumab (MSB0010718C) plus Best Supportive Care versus Best Supportive Care Alone as a Maintenance Treatment in Patients with Locally Advanced or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion of Frist-Line PlatinumContaining Chemotherapy

B9991009 JAVELIN200 A Study of Avelumab Alone or in Combination with Pegylated Liposomal Doxorubicin versus Pegylated Liposomal Doxorubicin Alone in Patients with Platinum Resistant/ Refractory Ovarian Cancer

BCRC122 RAPPER Review of Australian Prescribing Practices of Eribulin

BGB-290-103 Phase 1b Study to Assess the Safety, Tolerability, and Clinical Activity of BGB-290 in Combination with Temozolomide (TMZ) in Subjects with Locally Advanced or Metastatic Solid Tumours

BGB-900-103 A Phase 1B Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Sitravatinib in Combination with Tislelizumab in Patients with Advanced Solid Tumours

BO25126 APHINITY A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy plus Trastuzumab plus Placebo versus Chemotherapy plus Trastuzumab plus Pertuzumab as Adjuvant Therapy in Patients with Operable HER2-Positive Primary Breast Cancer

BO28407 KAITLIN A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines As Adjuvant Therapy In Patients With Operable HER2-Positive Primary Breast Cancer

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

C3441021 TALAPRO-2

Protocol Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Talazoparib in Combination with Physician's Choice of Enzalutamide or Abiraterone Acetate/Prednisone in Metastatic Castration-Resistant Prostate Cancer with DNA Damage Repair Deficiencies

C-550-01

A Phase 1/2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with AGEN2034 in Subjects with Metastatic or Locally Advanced Solid Tumours, and Expansion Into Select Solid Tumours

CA209-7DX Checkmate7DX

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-resistant Prostate Cancer

CA209-901 Checkmate-901

A Phase 3, Open-Label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

CA209-914 Checkmate-914

A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination Vs Placebo in Participants with Localized Renal Cell Carcinoma who Underwent Radical or Partial Nephrectomy and who are at High Risk of Relapse

CA209-9KD Checkmate9KD

A Phase 2 Study of Nivolumab in Combination with Either Rucaparib, Docetaxel, or Enzalutamide in Men with Castration-Resistant Metastatic Prostate Cancer

CanStem111P

A Phase III Study of BBI-608 plus Nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma

CANVACCS

CANcer patients' perspectives on coronavirus VACCination Survey (CANVACCS) research project

CBT-501

APOLLO-1

CLEE011A2301

MONALEESA-2

A Phase 1/2 Open Label, Multi-Center Dose Escalation and Expansion Study of Combination Immunotherapy APL-501 (Anti-PD-1) or Nivolumab with APL-101 (C-MET Inhibitor) in Locally Advanced or Metastatic Hepatocellular Carcinoma and Renal Cell Carcinoma

A Randomized Double-Blind, Placebo-Controlled Study of LEE011 in Combination with Letrozole for the Treatment of Postmenopausal Women with Hormone Receptor Positive, HER2-Negative, Advanced Breast Cancer who Received No Prior Therapy for Advanced Disease

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

Protocol Title

CL-SBP-101-03 CLSBP-101-03 A Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination with Nab-Paclitaxel and Gemcitabine in Subjects with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

CN1-101 A Phase I, Open Label, Multi-Center, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN1 in Patients with Advanced Solid Tumours or B-cell Lymphoma

CO39303 IPATential150 A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

CO41101 IPATunity170 A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Ipatasertib in Combination with Atezolizumab and Paclitaxel as a Treatment for Patients with Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

COGNO 16 01 NUTMEG A Randomized Phase II Study of Nivolumab and Temozolomide Vs Temozolomide in Newly Diagnosed Elderly Glioblastoma

CPI 0610-04 MANIFEST-2 A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

CP-MGA271-06 NORTH A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination with Retifanlimab or Tebotelimab in the First-Line Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

CS1002-101 A Phase Ia/Ib, Open-Label, Dose-Escalation and Dose-Expansion Study of the Anti-CTLA4 Monoclonal Antibody as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody in Subjects with Advanced Solid Tumours

CS1003-101 A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects with Advanced Solid Tumours

CTC0160 EMBRACE Phase 2 Clinical Trial of the PARP Inhibitor, Olaparib, in HR-deficient Metastatic Breast and Relapsed Ovarian Cancer in Patients without Germline Mutations in BRCA1 and BRCA2

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

D081CC00006 OLYMPIA

Protocol Title

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

D081SC00001 PROpel A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase III Study of Olaparib plus Abiraterone Relative to Placebo plus Abiraterone as First-Line Therapy in Men with Metastatic Castration- Resistant Prostate Cancer

D3615C00001

CAPItello-291

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

D3615C00001

CAPItello-291

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasrtib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer

D419JC00001 POTOMAC

A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG-Naive Non-Muscle-Invasive Bladder Cancer Patients

D5164C00001 ADAURA

A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

D967VC00001 DESTINYPanTumour02

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumours

DCC-2618-03-002

INTRIGUE

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 Vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumours After Treatment with Imatinib

Debio1143-SCCHN-301

TrilynX

A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation IntensityModulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

E7080-G000-218

Protocol Title

A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment

E7080-G000-307 CLEAR A Multicenter, Open-Label, Randomised, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab versus Sunitinib Alone in First-Line Treatment of Advanced Renal Cell Carcinoma

EARLI-001-CT01

A Phase 1, Open Label, Single Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EARLI-001 In Subjects with Locally Advanced or Metastatic Lung Cancer or Subjects with Metastases in the Lung or Liver of a Primary Cancer Origin Other Than Lung Cancer

FPT155-001

A Phase 1 Safety and Tolerability Study of FPT155 in Patients with Advanced Solid Tumours

GBG78_BIG1-13

PENELOPE B

Phase III Study Evaluating Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients With Hormone-receptor-positive, HER2-normal Primary Breast Cancer With High Relapse Risk After Neoadjuvant Chemotherapy

HC1119-CS-03 PROCADE A Multinational, Phase 3, Randomized, Double-Blind, Non-Inferiority, Efficacy and Safety Study of Oral HC 1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

HC1119-CS-03 PROCADE A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

I3Y-MC-JPBL MONARCH2

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant with or without Abemaciclib, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

I3Y-MC-JPBL MONARCH2

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant with or without Abemaciclib, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

I3Y-MC-JPCF MONARCH-E

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

I3Y-MC-JPCP

Protocol Title

An Open-Label, Randomized Phase 2 Study of the Impact of Food On Tolerability When Receiving Abemaciclib for Patients with Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

IBCSG 24-02 BIG 2-02 SOFT

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Post Menopausal Women with Endocrine Responsive Breast Cancer

ICON9

An International Phase III Randomised Trial of Cediranib & Olaparib Maintenance in Patients with Relapse Platinum Sensitive Ovarian Cancer

IMGN853-0417 SORAYA

A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

IMMU-132-13 Tropics-04

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan versus Treatment of Physician’S Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer

IMMU-132-13 Tropics-04

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer

IMMU-132-13 Tropics-04

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan versus Treatment of Physician’S Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer

INMB-001

Phase 1 Open-Label, Dose Escalation Study of INB03 in Patients with Metastatic Cancer with Increased Inflammatory Biomarkers in Peripheral Blood

IRFMN-EN-7556 ATTEND Phase 3 Double-blind Randomized Placebo Controlled Trial of Atezolizumab in Combination with Paclitaxel and Carboplatin in Women with Advanced/Recurrent Endometrial Cancer

J2J-MC-JZLA EMBER A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

Protocol Title

M13-694 VELIA A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel with or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subject with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

M19-037 A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 with ABBV368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects with Locally Advanced or Metastatic Solid Tumours

M19-345 A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination with ABBV-181 in Subjects with Locally Advanced or Metastatic Solid Tumours

MDNA11-01 ABILITY A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination with Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumours

MDV3100-10 PLATO A Phase 4, Randomized, Double Blind, Placebo Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients with Chemotherapy Naive Metastatic Castration Resistant Prostate Cancer

MDV3100-13 EMBARK A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide plus Leuprolide, Enzalutamide Monotherapy, and Placebo plus Leuprolide in Men with High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

MDV3100-13 EMBARK A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide plus Leuprolide, Enzalutamide Monotherapy, and Placebo plus Leuprolide in Men with High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy

MDV3100-14 PROSPER A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients with Non-metastatic Castration-Resistant Prostate Cancer

MDV3100-14 PROSPER Prosper: a Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safet Study of Enzalutamide in Patients with Non-metastatic CastrationResistant Prostate Cancer

MDV3100-14 PROSPER A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

MDV3800-06 TALAPRO-1

Protocol Title

A Phase 2, Open-Label, 2-Arm, Response Rate Study of Talazoparib in Men with DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer who Previously Received Taxane-Based Chemotherapy and Progressed On at Least 1 Novel Hormonal Agent (Enzalutamide And/Or Abiraterone Acetate/Prednisone)

MK-1308-001

A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumours

MK-3475-119

Keynote-119

MK-3475-564

Keynote-564

MK-3475-716

Keynote-716

MK-3475-B61

Keynote-B61

MK-7684-001

Keyvibe-001

MO28047 PERUSE

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy Per Physician'S Choice for Metastatic Triple Negative Breast Cancer (MTNBC)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy

Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-Risk Stage II Melanoma: a Randomized, Double-Blind Phase 3 Study

A Phase 2, Single-Arm, Open-Label Clinical Trial of Pembrolizumab plus Lenvatinib in Participants with First-Line Advanced/Metastatic Non-Clear Cell Renal Cell Carcinoma (NCCRCC) (Keynote-B61)

A Phase 1 Trial of MK-7684 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumours

A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination with Trastuzumab and a Taxane in First Line Treatment of Patients with HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer

MO29983 SAUL

An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

MS200647-0055 INTR@

PID BTC-055

A Phase II, Multicenter, Randomized, Placebo-Controlled Study of Gemcitabine plus Cisplatin with and Without M7824 as a First-Line Treatment of Biliary Tract Cancer

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

MX39795 CUPISCO

Protocol Title

A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who Have Received Three Cycles of Platinum Doublet Chemotherapy

ONT 380-206 HER2CLIMB Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 Vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

ORBIT-M

Optimized Response Biome for Immunotherapy Treatment

R2810-ONC-1540

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

R2810-ONC-1540

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death–1 (PD-1), in Patients with Advanced Cutaneous Squamous Cell Carcinoma

R2810-ONC-1540

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death–1 (PD-1), in Patients with Advanced Cutaneous Squamous Cell Carcinoma

SHR-1701-001 AUS

A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects with Advanced Solid Tumours

SHR3680-002

A Phase 1 Trial of SHR3680 with or Without SHR3162 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Statins-Lipidomics

Statins in Metastatic Castration-Resistant Prostate Cancer: Multi-Centre, Open Label Trial of Simvastatin in Addition to Docetaxel Chemotherapy for Metastatic CastrationResistant Prostate Cancer

TRIO033

NATALEE

A Phase 3 Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib with Endocrine Therapy as an Adjuvant Treatment in Patients with Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl with Ribociclib

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

Protocol Title

TROG 17.02 OUTRUN A Randomised Phase II Trial of Osimertinib with or Without Stereotactic Radiosurgery for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) with Brain Metastases

WO29637 IMmotion151 A Phase III, Open-Label, Randomiozed Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Bevacizumab versus Sunitinib in Patients with Untreated Advanced Renal Cell Carcinoma

WO30070 IMvigor130 A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (AntiPD-L1 Antibody) as Monotherapy and in Combination with Platinum-Based Chemotherapy in Patients with Untreated Locally Advanced or Metastatic Urothelial Carcinoma

WO39210 IMmotion010 A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients with Renal Cell Carcinoma at High Risk of Developing Metastasis following Nephrectomy

WO40242 IMvoke010 A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients with High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

WO41994 IMmotion250 A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab in Combination with Cabozantinib in Patients with Renal Cell Carcinoma who Experienced Disease Progression During or After Check Point Inhibitor Treatment

XL184-312 COSMIC 312 A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma who Have Not Received Previous Systemic Anticancer Therapy

XL184-313 COSMIC-313 A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

XL184-401 COSMIC-401 A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/day compared to 140 mg/day in Progressive, Metastatic Medullary Thyroid Cancer Patients

XNW7201-1-02 A Phase I, Open-Label, Multi-Center, Non-Randomized, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects with Advanced Solid Tumours

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

YH003002

Protocol Title

A Multicenter, Open-Label, Phase 1/2 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of YH003 in Combination with Toripalimab (Anti-PD-1 mAb) in Subjects with Advanced Solid Tumours

YH003004

A Study to Assess YH003 in Combination with Toripalimab(Anti-PD-1 Mab) Injection in Patients with Cancers

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — SINGAPORE

Abbrev. Title

CA209-74W Checkmate74W

Protocol Title

A Randomized, Multi-Center, Double-Blinded, Placebo-Controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination with Trans-Arterial Chemoembolization (TACE) in Patients with Intermediate-Stage Hepatocellular Carcinoma (HCC)

CLEE011A3201C RIGHT Choice

A Phase II Randomized Study of the Combination of Ribociclib plus Goserelin Acetate with Hormonal Therapy versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients with Hormone Receptor-Positive/ HER2-Negative Inoperable Locally Advanced or Metastatic Breast Cancer

D3614C00001 CAPItello-290

A Phase III Double-Blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel Vs Placebo+Paclitaxel as First-Line Treatment for Patients with Locally Advanced (Inoperable) or Metastatic TNBC

D9673R00005 HER2Real

A Multicountry, Multicentre, Non-interventional Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients with HER2-positive Unresectable or Metastatic Breast Cancer

IMMU-132-13 Tropics-04

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan versus Treatment of Physician’s Choice in Subjects with Metastatic or Locally Advanced Unresectable Urothelial Cancer

MS200095-0031

INSIGHT-2

A Phase II, Two Arm Study to Investigate Tepotinib Combined with Osimertinib in MET Amplified, Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy

PXL 252853 LIQUIK-01 Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

SKYSCRAPER-08 YO42138

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab plus Tiragolumab in Combination with Paclitaxel and Cisplatin compared with Paclitaxel and Cisplatin as First-Line Treatment in Patients with Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Y-mAbs 202

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients with High-Risk Neuroblastoma in First Remission. An International, Open-Label, Uncontrolled, Single-Arm, Multicenter, Phase 2 Trial CLINICAL TRIALS

MEDICAL ONCOLOGY

CLOSED TO RECRUITMENT — SINGAPORE

Abbrev. Title

Y-mAbs 203

Protocol Title

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor in Combination with Irinotecan and Temozolomide in Patients with High-Risk Neuroblastoma with Primary Refractory Disease or in First Relapse. An International, Single-Arm, Multicenter Phase 2 Trial

YO42138

SKYSCRAPER-08

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination with Paclitaxel and Cisplatin compared with Paclitaxel and Cisplatin as First-Line Treatment in Patients with Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

HAEMATOLOGY

Abbrev. Title

ALLG AML M22

Protocol Title

A randomized, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid Leukaemia in first complete remission

Aplastic Anaemia Registry Monash University - Aplastic Anaemia Registry

D8227C00001 ESCALADE ACE-LY-312

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤ 70 Years with Previously Untreated Non-GCB DLBCL

GS-US-352-4365 SRAMMB-352-4365

Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Postpolycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

KRT-232-101 BOREAS

A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT 232 in Subjects with Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (Post-PV-MF), Or Post Essential Thrombocythemia MF (Post-ET-MF) Who Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment

LOXO-BTK-20019 BRUINMCL-321

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma

M07-001 PNH Registry Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry

MDS Database

A retrospective/prospective study of patients with Myelodysplasia in South Australia–diagnostic phenotype, outcome and the risk of iron overload

MRDR Database Myeloma and Related Disease Registry

OPEN TO RECRUITMENT — AUSTRALIA

HAEMATOLOGY

OPEN TO RECRUITMENT — AUSTRALIA

Abbrev. Title

Myeloma 1000

Protocol Title

Myeloma 1000 Project

NEOD001-301 AFFIRM-AL

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis

PHI-101-001

A Prospective, Phase la/b, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the FLT3 Inhibitor, PHI-101, Alone in Subjects with Relapsed or Refractory Acute Myeloid Leukaemia (AML)

PXS5505-MF-101

A Phase 1/2a Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients with Primary, Postpolycythemia Vera or Post-essential Thrombocythemia Myelofibrosis

ZN-d5-001

Phase 1 First in Human Dose-Escalation Study of ZN-d5 as a Single Agent in Subjects with Non-Hodgkin Lymphoma or Acute Myeloid Leukaemia

HAEMATOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

Protocol Title

207499 DREAMM8 A Phase 3, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8)

207503 DREAMM7 A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma

3674-0013 ENHANCE A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome

54767414MMY3003 POLLUX

Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed or Refractory Multiple Myeloma

54767414MMY3008 MAIA A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy

80-6946 17833

CHRONOS 4

A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination with Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)

ACE-536-MDS-002

COMMANDS

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anaemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

ACE-CL-309 ASCEND

A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with R/R Chronic Lymphocytic Leukaemia

ALLG CML7

A Phase 2 study of efficacy and safety of Pegasys in patients with Chronic Myeloid Leukaemia in PCR +ve complete or near complete cytogenetic remission on Glivec at 600mg daily or maximum tolerated dose

Indication Sponsor

Principal Investigator Location

Myelodysplastic

HAEMATOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

ALLG CML8 TWISTER

Protocol Title

A Phase 2 study of withdrawal of imatinib therapy in adult patients with chronic phase chronic myeloid leukaemia in stable complete molecular remission

ALLG M13

High Dose Cytarabine and Fludarabine Without Anthracycline for Patients with Core Binding Factor Acute Myeloid Leukaemia

ALLG MDS4

A Randomised Phase 2 Study Comparing the Efficacy of 5-Azacitidine Alone versus Combination Therapy with Lenalidomide and 5-Azacitidine in Patients with Higher Risk Myelodysplastic Syndromes (Mds) and Low Marrow Blast Count Acute Myeloid Leukaemia (Aml)

ALLG MM14

A Prospective Randomised Phase 2 Study of Single Agent Pomalidomide Maintenance versus Combination Pomalidomide and Low Dose Dexamethasone Maintenance following Induction with the Combination of Pomalidomide and Low Dose Dexamethasone in Patients with Relapsed and Refractory Myeloma Previously Treated with Lenalidomide

ALLG MM17

A Multicentre Single Arm Study of Carfilzomib-Thalidomide-Dexamethasone (CarTD) for Newly Diagnosed Transplant-Eligible Multiple Myeloma (TE NDMM) Patients Refractory to Initial Bortezomib-Based Induction Therapy

ALLG NHL16 PRIMA A Multicentre, Phase 3, Open-Label, Randomized Study in Patients with Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy with Rituximab (MabThera(R)) After Induction Of Response with Chemotherapy Plus Rituximab In Comparison with No Maintenance Therapy

ALLG NHL33 WAMM

An ALLG Window Study of Acalabrutinib plus Rituximab followed by R-DHAOx+ASCT in fit Mantle Cell Lymphoma

AMARC_03-16

A Randomized Phase 2 Study of Bortezomib, Cyclophosphamide and Dexamethasone Induction (VCD) compared with VCD and Daratumumab Induction followed by Daratumumab Maintenance (VCDD) for the Initial Treatment of Transplant Ineligible Patients with Multiple Myeloma

BGB-3111-212

Rosewood An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab compared with Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

BGB-3111-212

Rosewood An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab compared with Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

HAEMATOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

Protocol Title

BGB-3111-304 Sequoia An International, Phase 3, Open-Label, Randomized Study of BGB-3111 compared with Bendamustine Plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma (CLL/SLL)

BGB-3111-305 Alpine A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) compared with Ibrutinib in Patients with Relapsed / Refractory Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma

BGB-3111-306 Mangrove A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Study Drug plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

BGB-3111-LTE1

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B-cell Malignancies

BO25323 CLL14

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients with CLL and Coexisting Medical Conditions

C16019

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients with Multiple Myeloma following Autologous Stem Cell Transplant

C25003

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients with Advanced Classical Hodgkin Lymphoma

D8220C00008 ASSURE

A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukaemia

EFC12522 IMROZ

A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination with Bortezomib (Velcade®), Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

GCT3013-05

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

HAEMATOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

GO29365

Protocol Title

A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumour Activity of Polatuzumab Vedotin in Combination with Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

GO29781

An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined with Atezolizumab in Patients with Relapsed or Refractory B-Cell NonHodgkin's Lymphoma and Chronic Lymphocytic Leukaemia

GO39942 POLARIX A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination with Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients with Diffuse Large B-Cell Lymphoma

GS-US-352-0101

SIMPLIFY1

A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects with Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

M13-494 CANOVA A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

MDS 04-30 INSPIRE A Phase 3, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients with Myelodysplastic Syndrome After Failure of a Hypomethylating Agent

MOR208C204 B-MIND A Phase 2/3, Randomised, Multicentre Study of Tafasitamab with Bendamustine Versus Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)

P-3001 PANTHER A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukaemia, or LowBlast Acute Myelogenous Leukaemia

PCI-32765FLR3001 SELENE A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

HAEMATOLOGY

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

PCI-32765MCL3002 SHINE

Protocol Title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects with Newly Diagnosed Mantle Cell Lymphoma

PCYC-1143-CA SYMPATICO

SGN35-014 ECHELON-2

Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients with CD30-positive Mature T-cell Lymphomas

TG1701-101

A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients with B-Cell Malignancies

TL-895-201

A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

RADIATION MEDICINE

Abbrev. Title

Protocol Title

AG0115R CTC0138 SPAR A Randomized, Placebo-Controlled Phase II Trial of Simvastatin in Addition to Standard Chemotherapy and Radiation in Preoperative Treatment for Rectal Cancer

ANZ 1601 BIG 16-02 EXPERT Examining personalised radiation therapy for low risk early breast cancer

ANZUP1801 DASL-HiCaP Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

ERUPT External Beam Radiotherapy and Urethral Strictures in Prostate Cancer Treatment

HyperArc Registry HyperArc Registry Study

LIBERATE Clinical Registry of Focal Low Dose Rate Brachytherapy in Men with Biopsy Confirmed Low-Intermediate Risk Prostate Cancer

Liver SBRT Multi-Institutional Experience of Liver SBRT in Australia - Patterns of Practice, Treatment Outcomes and Toxicities

COGNO 19/03 MAGMA The Multi-Arm GlioblastoMa Australasia (MAGMA) Trial

COGNO 19/03 MAGMA The Multi-Arm GlioblastoMa Australasia (MAGMA) Trial

AG0118PS MASTERPLAN A Randomized Phase II Study of MFOLFIRINOX and Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer with High Risk and Locally Advanced Disease

SNUC

Genomic Characterisation of Sinonasal Undifferentiated Carcinomas

TREMOR Safety and Effectiveness of Frameless Linac-Based Stereotactic Radiosurgery On Tremor in Patients with Essential Tremor or Parkinson's Disease

TROG 19.06 DECREASE Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

RADIATION MEDICINE

CLOSED TO RECRUITMENT — AUSTRALIA

Abbrev. Title

ALTG 13 008 PEARL

Protocol Title

A Randomised Phase 3 Trial of Palliative Care Early in Advanced Lung Cancers

ANZUP1303 ENZARAD Randomised Phase 3 Trial of Enzalutamide in Androgen Deprivation Therapy with Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

ANZUP1303 ENZARAD Randomised Phase 3 Trial of Enzalutamide in Androgen Deprivation Therapy with Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

AVATAR Stereotactic Radiotherapy for Oligoprogressive ER-positive Breast Cancer

AVATAR Stereotactic Radiotherapy for Oligoprogressive ER-positive Breast Cancer

CROSSPET

A prospective, single arm, multi-centre study of post neoadjuvant chemoradiation PET as predictor of pathological response in patients with localised oesophageal cancer

ORATOR II

A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery

SHRINC

A Phase II Prospective Trial of Stereotactic Hypofractionated Radiation for Multiple (3-10) Cerebral Metastases Including Neurological and Cognitive Assessment

TROG 12.01

A Randomised Trial of Weekly Cetuximab and Radiation versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma

TROG 14.04 HART

Deep Inhalation Breath Hold for Reduction of Cardiac Toxicity in Patients with Left Sided Breast Cancer Undergong Radiotherapy