Recruitment nearing completion for world first trial for bladder cancer

ASSOCIATE PROFESSOR ANDREW WEICKHARDT PRESENTING THE PCR-MIB CLINICAL TRIAL POSTER.

In 2016 ANZUP launched a world first bladder cancer trial where cancer has spread into the wall of the bladder. The current standard treatment for bladder cancer is chemotherapy and radiation but this study will investigate if it is safe and effective to add an additional new drug called ‘pembrolizumab’ to this standard therapy regimen.

Pembrolizumab is a new treatment that “takes the brakes off” the immune system, allowing it to attack cancers more effectively. Pembrolizumab belongs to a class of drugs called PD1 inhibitors, and at present is approved for use in Australia for the treatment of advanced melanoma in adults.

In some patients bladder cancer may spread deeper within the bladder but not more widely. Chemotherapy given at the same time as radiation to the bladder may be an attempted cure for these patients. Yet one in three treated this way will still have a relapse. Potentially giving a PD1 inhibitor at the same time may activate the body’s immune system to fight the cancer. This trial will recruit 30 patients at six different hospitals within Australia. Recruitment is almost complete with 23 patients now enrolled. In addition, a pre-planned safety and efficacy analysis was undertaken after the first 10 patients were enrolled and completed treatment. The results from this interim analysis demonstrated acceptable safety, and promising efficacy. There were no unexpected safety concerns. Follow up of these patients and additional patients will better determine the efficacy and safety of combining pembrolizumab with standard therapy.

Everyone involved in this trial are now eager to see the trial completed and undertake the follow up of patients.

If you or a member of your family would like to know more about the ANZUP led PCR MIB clinical trial, please discuss with your GP or specialist or refer to our website: https://www.anzup.org.au/content. aspx?page=bladdercancertrialdetails.