This phase 2 trial will investigate the safety and effectiveness of nivolumab (Opdivo) in recurrent prostate cancer (PC). The main outcome will be disease control. This trial is recruiting at two locations in Boston, MA, US.
Prostate cancer (PC) is a highly treatable cancer in men. Patients are usually first treated with surgery or radiation. After this, many patients are monitored to see if PC returns. If blood tests reveal an increase in prostate-specific antigen (PSA), PC may have returned. Preventing recurrent PC (PC) is important in these patients.
Nivolumab is a new cancer drug. It is an immune checkpoint inhibitor (ICI). It targets a protein called PD-1. Nivolumab helps the immune system to detect and kill cancer cells. This trial is evaluating the effectiveness of nivolumab in patients with high-risk PC that has come back after surgery or radiotherapy.
Who are they looking for?
This study will recruit 34 male patients with a history of prostate adenocarcinoma that has been treated with surgery or radiotherapy. Patients must have evidence of recurrent PC based on PSA levels. Participants must have a normal blood and biochemistry result. Contraceptive measures must be used by men during the trial.
Participants cannot be on androgen deprivation therapy (ADT) during the trial. Recent (within 14 days) surgery or radiation therapy is excluded. Patients with immune conditions or active infections are excluded from the trial. Patients cannot have had prior treatment with ICIs.
How will it work
All patients will receive treatment with nivolumab. It will be administered every 4 weeks. Patients will be separated into groups depending on PD-L1 protein expression in the tumor. PDL-1 is the protein that binds to PD-1. The trial will last up to 2 years.
The main outcome will be disease control at 12 weeks.