AURORA Study: Immunotherapy's Role in Treating Urinary Tract Squamous Cell Carcinoma
By the Aurora Trial Management Team, Southampton Clinical Trials Unit
Urinary tract squamous cell carcinoma (UTSCC) is a rare form of cancer, comprising approximately 5% of bladder and urinary tract cancers. As a result, research into the disease has been limited and patients are often excluded from participating in bladder cancer clinical trials. Survival rates for these patients are generally not as good as the more common types of urinary tract cancer and there are currently no treatments that are proven to extend survival.
Atezolizumab has already become an established treatment in a number of other cancers, such as some lung and breast cancers and even some other urinary tract cancers. It works by allowing the body’s own immune system to recognise and destroy cancer cells. Some cancer cells produce a protein that allows them to evade the body’s immune response to cancer - atezolizumab blocks that protein from doing so, and thereby allowing the immune system to work effectively.
The trial is aiming to recruit 33 patients with UTSCC who have not had immunotherapy before. All patients will have an infusion of atezolizumab every four weeks, along with blood tests and a review by their oncology team. They will also have a CT scan every 12 weeks and will stay on the trial treatment for up to one year.
The research team will analyse how patients respond to the treatment, including any side effects and whether the progression of the cancer is slowed. We will then hopefully be able to see whether atezolizumab could be effective for this patient group.
As part of the trial, a blood sample is also being collected from patients before starting treatment and at a couple of points whilst on treatment. These blood samples will be analysed to try to identify markers that can help predict which patients will respond to this treatment and which will not.
The AURORA trial is being run by Southampton Clinical Trials Unit (SCTU) in collaboration with the International Rare Cancers Initiative (IRCI) Genitourinary Cancer Working Group, which aims to prioritise research into rare cancers such as UTSCC. The atezolizumab for the trial is provided by Roche, however the Southampton Clinical Trials Unit is responsible for the design and implementation of the study. The trial is currently open to recruitment at 12 sites across the UK, including London (Royal Marsden & UCLH), Southampton, Cardiff, Glasgow, Edinburgh, Nottingham, Middlesborough, Manchester, Liverpool, and Preston. If AURORA shows evidence that the treatment is safe and effective, then the team plans to develop future larger trials which could be run internationally.
Professor Simon Crabb, Professor of Experimental Cancer Therapeutics at the University of Southampton and Chief Investigator of the AURORA trial, says:
“There is a real need for research into this rare cancer, to provide patients with better treatment options. We hope that this trial will give us the evidence to show whether immunotherapy could be effective for these patients and lead to more trials in the future.”
Explore AURORA with a 2 minute infographic video:
Insights from Professor Simon Crabb, AURORA’s Chief Investigator:
