Conditions
Metastatic Castration-Resistant Prostate Cancer
Trial Purpose
Keynote 365 is a phase 1B/2 study to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). Currently enrolling cohorts are*:
Treatment emergent neuroendocrine carcinoma (t-NE) cohorts
- Cohort I
- Arm 1 pembrolizumab+carboplatin+etoposide
- Arm 2 carboplatin+etoposide.
Entrance criteria for Cohort I:
- Prior androgen deprivation therapy (ADT) for metastatic prostate cancer
- < 2 chemotherapies for mCRPC
- < 2 second generation hormonal therapies for mCRPC
- No prior treatment for prostate cancer with platinum-containing drugs
Adenocarcinoma cohort:
- Cohort J
- Arm J1 belzutifan
- Arm J2 pembrolizumab + belzutifan (Arm J2 is not currently enrolling)
Entrance criteria for Cohort J:
- Prior docetaxel for metastatic castrate resistant prostate cancer (mCRPC)
- < 1 other chemotherapy for mCRPC
- < 2 second generation hormonal therapies
Additional criteria apply and only an HCP can determine if you are eligible.
Primary objectives :
- Safety and tolerability of pembrolizumab combination therapies to estimate the PSA response rate for each combination cohort
- Evaluate the Objective Response Rate (ORR) for each cohort based on RECIST 1.1 by Blinded Independent Review
* Enrollment status updated as of 18Sep2023
CLINICALTRIALS.GOV IDENTIFIER
NCT02861573
EudraCT Number
2016-002312-41
EU CT Number
2023-506987-15
When you talk with your doctor or clinical trial team member, please have the trial identifier 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 trial
Current 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 participants – 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
- Trial start date November 17, 2016
- Estimated primary completion date October 22, 2027
- Estimated trial 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 risks and possible benefits are for participants
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