Conditions
Metastatic Castration-Resistant Prostate Cancer
Trial Purpose
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.
Effective with Protocol Amendment 08, enrollment into Cohorts A, B, C, and D was closed.
Effective with Protocol Amendment 14, enrollment into Cohorts E, F, G, and H was closed (not due to any safety issues). No further efficacy and survival follow-up assessments will be collected in Cohorts A through H.
Effective with Protocol Amendment 16, enrollment into Cohort J was closed (not due to any safety issues).
NATIONAL TRIAL REFERENCE NUMBER
NCT02861573
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
Male
About The Study
Trial Phase
Trial Phase 1
Investigational medication is tested for safety on a relatively small group of 20 to 100 volunteers who are usually healthy, but not always. Phase 1 trials may happen in a doctor’s office or a hospital.
Trial Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Actual study start date November 17, 2016
- Estimated primary completion date October 22, 2027
- Estimated study completion date October 22, 2027
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risksRiskChance (likelihood) for an event, reaction or health problem to happen and possible benefits are for participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant.
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about