This trial is aiming to assess the effectiveness of nivolumab (Opdivo) with or without ipilimumab (Yervoy) in treating metastatic prostate cancer according to the percentage of CD8 cells patients have. The main outcomes that are to be measured are the clinical benefit rate and the percentage of CD8 cells on biopsy during treatment. This trial is to be carried out in sites across the United States.
Metastatic cancer can be difficult to treat. Metastatic cancer can be resistant to treatment and patients can frequently relapse. Immunotherapy drugs such as nivolumab and ipilimumab have improved the outcomes of patients with metastatic cancer. CD8 cells are immune cells that can be increased in certain types of cancer. The use of CD8 cells as a predictive factor for the effectiveness of nivolumab with or without ipilimumab has not been evaluated.
This trial will evaluate the effectiveness of nivolumab with or without ipilimumab in patients with metastatic prostate cancer based on the quantity of CD8 cells. The main outcomes to be measured are the clinical benefit of the treatments and also the percentage of CD8 cells in tumor biopsies.
Who are they looking for?
This trial is looking to recruit 220 patients with metastatic prostate cancer. Patients must agree to use effective birth control or avoid becoming pregnant for the duration of this study. Patients will need to provide a tissue sample (biopsy) that has not been previously irradiated. Participants must have adequate liver, kidney, and blood cell counts.
Patients will be excluded if they are pregnant or breastfeeding, have significant gastrointestinal disease, lung disease, heart disease, or have received an organ transplant. Patients will also be excluded if they have received a live vaccine within 30 days of the first dose.
How will it work
There will be five arms in this trial. Patients will be divided into these groups based on their percentage of CD8 cells. They will receive nivolumab alone or nivolumab and ipilimumab at different doses.
Patients will be monitored for the clinical benefit for up to 2 years. The percentage CD8 cells in tumor biopsies and side effects will also be monitored.