Grants and Awards

Infrastructure Grants

Funds provided by Cancer Australia to support ANZUP infrastructure are managed by the University of Sydney NHMRC Clinical Trials Centre and therefore not reported in the financial accounts of ANZUP unless transferred in support of specific expenses incurred by ANZUP . Grants contributing to ANZUP infrastructure costs during the 2020-21 period are outlined below .

Funding

Cancer Australia Infrastructure Grant: 1 July 2018 to 30 June 2021, AUD$1,500,000 awarded to ANZUP and our collaborator on the grant NHMRC CTC . During this reporting period AUD$270,750 was transferred to ANZUP and was reported in the Annual Accounts .

Research Grants

Funds provided by Cancer Australia, the National Health and Medical Research Council, philanthropic funding bodies and pharmaceutical companies in support of ANZUP trial coordination are managed by the University of Sydney acting through NHRMC Clinical Trials Centre, and therefore not reported in ANZUP’s financial accounts . Funds to support ANZUP sponsored trials and site payments, insurance and other trial related costs are transferred to ANZUP and are reflected in these accounts . ANZUP grant income and expenditure during this reporting period are included in the 2020/2021 financial accounts .

Grants awarded to ANZUP Cancer Trials Group during this reporting period are listed below:

BCGMM: A randomised phase III trial adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer . Funding by Cancer Australia AUD$457,143 (2013-2018) . AUD$70,000 was transferred to ANZUP and reported in the annual accounts .

BL.12: A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen . Funding by NCIC Clinical Trials Group AUD$1,384,662, Specialised Therapeutics AUD$250,000 (2015-2018) . During this reporting period no funds were transferred to ANZUP . DASL-HiCaP: A randomised phase III 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 . Funding by Bayer USD$33,777,579 . During this period USD$765,000 was transferred to ANZUP and reported in the annual accounts .

ENZAMET: A randomised phase III trial of Enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer . Funding by Astellas AUD$17,131,966 (2014-2020) . During this reporting period USD$15,400 was transferred to ANZUP and was reported in the annual accounts .

ENZA-p: A randomised phase II trial using PSMA as a therapeutic agent and prognostic indicator in men with metastatic castrationresistant prostate cancer treated with enzalutamide . Funding by

Prostate Cancer Foundation of Australia AUD$4,000,000,

Endocyte USD$320,000,

St Vincent’s Clinic Foundation

AUD$400,000, GenesisCare

AUD$300,000, and Roy Morgan

Research Ltd AUD$300,000 (2020-2024) . During this reporting period AUD$2,333,942 was transferred to ANZUP and was reported in the annual accounts .

ENZARAD: A randomised phase III trial of Enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised prostate cancer . Funding by Astellas AUD$11,946,080 (2014-2020) . During this reporting period no funds were transferred to ANZUP .

KEYPAD: A phase II trial using denosumab and pembrolizumab in clear cell renal carcinoma . Funding by Merck Sharpe Dohme and Amgen AUD$2,454,925 . During this reporting period no funds were transferred to ANZUP .

Pain Free TRUS B: A placebo-controlled, randomised trial of methoxyflurane to reduce the discomfort of prostate biopsy . Funding by Cancer Australia AUD$354,764, Prostate Cancer Foundation of Australia AUD$242,331 (2015-2018) . During this reporting period no funds were transferred to ANZUP .

PCR MIB: Pembrolizumab with ChemoRadiotherapy as treatment for Muscle Invasive Bladder Cancer . Grant funding support from Merck Sharp & Dohme (Australia), AUD$455,800 to conduct the study, anticipated to take up to 5 years . During this reporting period, no funds were transferred to ANZUP .

PET-MET: A retrospective, multi-centre study using scans and data obtained from patients enrolled onto the ENZAMET trial who underwent PSMA PET imaging within 3 months of enrolment . Funding Astellas AUD$550,000 (2020-2022) . During this reporting period, AUD$150,000 was received and reported in the annual accounts .

Phase III Accelerated BEP (Cancer Australia and Cancer Council Australia): A randomised trial of accelerated versus standard BEP chemotherapy for intermediate and poor risk advanced germ cell tumours . Funding by Cancer Australia AUD$363,583, Cancer Council Australia AUD$222,000 (2013-2018) . During this reporting period AUD$30,000 was transferred to ANZUP and is reported in the annual accounts .

RAMPART: An international investigator-led Phase III multi-arm multi-stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse . Funding by University College London USD$2,080,000 (2020-2030) . During this reporting period USD$295,200 was received and reported in the annual accounts .

RetroPSMA: A retrospective study to identify clinical predictors of early metastatic disease using PSMA PET imaging . Funding Astellas AUD$500,000 (2021-2023) . During this reporting period AUD$250,000 was received and reported in the annual accounts . TheraP: An open label, randomised, stratified, 2-arm, multicentre phase 2 trial of Lu-PSMA617 theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer . Funding received from PCFA and Endocyte AUD$2,525,000 . During this reporting period AUD$100,000 was received and reported in the annual accounts .

TIGER: A randomised Phase 3 trial comparing conventionaldose chemotherapy using paclitaxel, ifosfamide, citplasin (TIP) with high-dose chemotherapy using mobilizing paclitaxel plus ifosfamide followed by high-dose carboplatin and etoposide (TI-CE) as first salvage treatment in relapsed or refractory germ cell tumours (TIGER) . Funding Movember AUD$540,000 . During this reporting period, no funds were transferred to ANZUP .

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 Funding from IPSEN AUD$1,173,201 (2018-2023) . During this reporting period AUD$100,000 was received and reported in the annual accounts .

UNISoN: A phase II sequential cohort trial of single agent nivolumab, then combination ipilimumab + nivolumab in metastatic or unresectable non-clear cell renal cell carcinoma . Funding from Bristol Myers Squibb AUD$1,681,822 (2017-2022) . During this reporting period, no funds were received .

#UpFrontPSMA: A co-badged randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer . Funding by Peter McCallum AUD$115,579 (2019-2022) . During this reporting period AUD$38,434 was received and reported in the annual accounts .