Actively Recruiting
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Led by Merck Sharp & Dohme LLC · Updated on 2026-02-17
1200
Participants Needed
21
Research Sites
609 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male with histologically or cytologically confirmed prostate adenocarcinoma, with or without neuroendocrine features depending on cohort
- Able to provide tumor tissue biopsy or archival specimen as required by cohort
- Evidence of prostate cancer progression within 6 months prior to screening, except for de novo neuroendocrine prostate cancer participants
- Ongoing androgen deprivation therapy with serum testosterone below 50 ng/dL, started at least 4 weeks before first study dose and continuing during study (except for certain neuroendocrine participants)
- Stable bone resorptive therapy for at least 4 weeks before first study dose if applicable
- Agreement to use contraception or abstain from heterosexual intercourse during treatment and specified time after last dose depending on drug
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 as specified per cohort
- Prior treatments as required per cohort, such as docetaxel, abiraterone acetate, enzalutamide, or chemotherapy, with specified treatment durations and intervals
You will not qualify if you...
- Prior anticancer monoclonal antibody within 4 weeks before study therapy or unresolved side effects from prior antibody treatment
- Chemotherapy, targeted therapy, abiraterone, enzalutamide, or radiation therapy within 2 weeks before study therapy or unresolved side effects
- Participation in another investigational study within 4 weeks before randomization
- Immunodeficiency or systemic steroid or immunosuppressive therapy within 7 days before randomization
- Treatment with therapeutic radiopharmaceuticals for prostate cancer within 4 weeks prior to study
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Prior participation in pembrolizumab or related anti-PD-1/PD-L1 therapy trials
- Known HIV infection or active Hepatitis B or C
- Live vaccine within 30 days before first study dose
- Active central nervous system metastases or carcinomatous meningitis
- Superscan bone scan preventing evaluation of new metastases
- Prior solid organ or bone marrow transplant
- Specific cohort-related exclusions such as seizures, CYP3A4 inhibitor or inducer use, heart conditions, neuropathy, significant fluid accumulation, uncontrolled hypertension, liver disease, and others as detailed per cohort
- Prior treatment with platinum-containing compounds for Cohort I
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Call for Information (Investigational Site 2041)
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Call for Information (Investigational Site 2091)
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
Call for Information (Investigational Site 2094)
Portland, Oregon, United States, 97239
Actively Recruiting
4
Call for Information (Investigational Site 0008)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
Call for Information (Investigational Site 0019)
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
6
Call for Information (Investigational Site 2090)
Germantown, Tennessee, United States, 38138
Actively Recruiting
7
Call for Information (Investigational Site 0016)
Seattle, Washington, United States, 98109
Actively Recruiting
8
MSD Australia
North Ryde, Australia
Actively Recruiting
9
Merck Canada
Kirkland, Quebec, Canada, H9H 4M7
Actively Recruiting
10
MSD Denmark
Glostrup Municipality, Denmark
Actively Recruiting
11
MSD France
Paris, France
Actively Recruiting
12
MSD Ireland (Human Health) Ltd.
Dublin, Ireland
Actively Recruiting
13
MSD Italia S.r.l.
Rome, Italy
Actively Recruiting
14
MSD Comercializadora, S. de R.L. de C.V.
Mexico City, Mexico
Actively Recruiting
15
Merck Sharp & Dohme BV
Haarlem, Netherlands
Actively Recruiting
16
Merck Sharp & Dohme (New Zealand) Ltd.,
Auckland, New Zealand
Actively Recruiting
17
MSD Polska Sp. Z o.o.
Warsaw, Poland
Actively Recruiting
18
Merck Sharp and Dohme de Espana S.A.
Madrid, Spain
Actively Recruiting
19
MSD Sweden
Stockholm, Sweden
Actively Recruiting
20
Merck Sharp & Dohme Ilaclari Ltd. Sti
Istanbul, Turkey (Türkiye)
Actively Recruiting
21
Merck Sharp & Dohme Ltd.
London, United Kingdom
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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