The commonest kind of advanced kidney cancer is called clear cell kidney cancer. Immune therapies have been shown to be effective in about a quarter of patients with advanced clear cell kidney cancer after the standard tablet treatment has failed.
This study will test if a drug (denosumab) usually used to treat osteoporosis (thinning of the bones) or cancer that has spread to the bones, can be added to the immune therapy to increase the ability of the body’s immune system to attack kidney cancer cells. This study is designed to assess the effects and safety of the combination of two drugs; pembrolizumab and denosumab. All participants on the trial will receive both treatments. Blood and cancer samples will be collected from each patient to better understand who has benefited and who has been failed by the treatment combination.
This study aims to find how safe, tolerable and effective a new treatment called Cabozantinib is for non-clear cell kidney cancer. All patients will take cabozantinib orally every day, until the medication is no longer effective. There is no placebo (inactive treatment), which means that everyone who takes part in the trial will receive the active cabozantinib drug.
Cabozantinib is an anti-cancer drug that works by blocking cancer cell growth. Cabozantinib has previously been used in the treatment of many cancers, including clear cell kidney cancer and thyroid cancer. However, it has not been tested in people with non-clear cell kidney cancer.
About 48 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia.
FASTRACK II Trial
Surgery is the standard treatment for primary kidney cancer, however, in some cases surgery is either not possible or other health problems make surgery high risk. This study involves a relatively new, highly precise multidirectional radiotherapy technique called Stereotactic Ablative Body Radiotherapy (SABR) and all participants will receive this radiotherapy technique. The aim of the study is to test the ability of this technique to control the cancer within the kidney for those people where surgery is not an option, as well as to examine the side effects of the treatment, including how it may affect your kidney's function.
Interested in this trial? Print off the FASTRACK II details from the Australia New Zealand Clinical Trials Registry and take it to your GP.
In this clinical trial ANZUP will test whether new immune treatments can help people with rare kidney cancer (‘non-clear cell’ cancer). Non-clear cell represents approximately 25% of people with kidney cancer; and because it is rare there are no treatments currently reimbursed in Australia.
The UNISoN trial will test immune treatments in two different ways; firstly we will find out how well one immune treatment (nivolumab) works alone. If this is unhelpful by itself, then people can continue taking nivolumab but also add in a 2nd immune treatment (ipilimumab). We will discover how many people will benefit from one drug alone, and by doing detailed laboratory testing of people’s cancer samples, hope to also learn who will only benefit from taking both treatments together.
Nivolumab and ipilimumab have been used alone or together in many cancers, so the side-effects are well known and should be manageable. Immune treatments help some people with cancer, especially those with melanoma, common (clear cell) kidney cancer, lung and bladder cancer. Unfortunately they are much less effective in other cancers (like pancreas, prostate and brain cancers). Nivolumab and ipilimumab have not been tested in people with non-clear cell kidney cancers, so ANZUP is delighted to ask this question, and hope to help people with this rare disease.
This trial is now closed to recruitment and in follow up.