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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 medicines
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
* Enrolment status updated as of 18Sep2023
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NATIONAL TRIAL REFERENCE NUMBER | NCT02861573 |
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Conditions | Metastatic Castration-Resistant Prostate Cancer |
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Age Range | 18+ |
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Sex | Male |
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Current trial phase | 2 |
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Trial start and end dates | [11-17-2016] [10-22-2027] |
About the trial
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.
Conditions
Metastatic Castration-Resistant Prostate Cancer
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.
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 locations (1)
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.