This phase 2 trial aims to evaluate the benefit of addingtremelimumabtodurvalumab, two new types of immunotherapy, for metastatic castration-resistant prostate cancer. The main outcome to be investigated is treatment response. The trial is recruiting in several locations in Canada.
The details
Metastatic castration-resistant prostate cancer is prostate cancer that continues to spread despite standard hormone therapy. Early results have shown that durvalumab may be effective in treating this type of prostate cancer. It works by allowing the immune system to detect cancer and stimulates an immune response. This may help to slow down the growth of cancer and may cause cancer cells to die. Tremelimumab is a new type of drug for various types of cancers. It works in a similar way to durvalumab and may improve the effect of durvalumab.
This study will examine the benefit of adding tremelimumab to durvalumab for metastatic castration-resistant prostate cancer. The effectiveness and safety of this treatment combination will be monitored for up to 2 years. Treatment response will be measured using blood tests and improvements will be compared to a standardized set of rules of cancer progression.
Who are they looking for?
This study will recruit about 74 men with metastatic prostate cancer, who are no longer responding to standard hormone therapy. Participants must have very low testosterone levels (near castrate levels). Any ongoing standard hormone therapy must be discontinued at least 4 weeks before taking part. Previous chemotherapy withdocetaxel (Taxotere) is permitted. Any previous secondary hormone therapy with abiraterone acetate (Zytiga)and/orenzalutamide (Xtandi)must have been unsuccessful. Previous radiation therapy (external beam radiation therapy orradium-223) or prostate surgery is permitted provided it was completed more than 4 weeks before the study. Full blood counts will be examined before participation.
Patients cannot take part in the trial if the cancer has spread to the brain. Having another type of cancer than requires treatment will also prevent patients from taking part. Patients should not have hepatitis, HIV, an active infection, an autoimmune disease (for example Crohn’s disease, lupus, or celiac disease), an immunodeficiency condition, a history or increased risk for heart disease, or present with any significant or uncontrolled medical illnesses.
How will it work
Participants will be randomly assigned to either undergo treatment with durvalumab alone or durvalumab in combination withtremelimumab. Durvalumab will be administered by infusion into the vein (lasting 60 minutes) on Day 1 of every treatment cycle (that lasts 4 weeks). Tremelimumab will also be administered by infusion into the vein (lasting 60 minutes) on Day 1 of every treatment cycle.
The effectiveness and safety of this treatment combination will be monitored for up to 2 years. Treatment response will be measured using blood tests and improvements will be compared to a standardized set of rules of cancer progression.
