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
