[WCGIRB - IAA] Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

Principal Investigator

Julie Graff

Study Purpose

The purpose of this study is to evaluate the safety and tolerability of the study drug, called pembrolizumab (MK-3475), in combination with other drugs to see if certain combinations are better, the same, or worse than the usual approach in treating metastatic castration-resistant prostate cancer (mCRPC).

Medical Condition(s)

Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Pembrolizumab (MK-3475)

Eligibility Criteria

- Must have metastatic castration-resistant prostate cancer (mCRPC)
- Must have prostate cancer progression within 6 months of screening
- Must provide newly biopsied tumor tissue, or have provided archived biopsied tumor tissue from a tumor which was not treated with radiation
- Must have adequate organ function

- Must not have received anticancer monoclonal antibody drugs (mAb) within 4 weeks prior to joining
- Must not have an active immune disease that required systemic treatment in the past 2 years
- Must not be receiving any form of immunosuppressive therapy within 7 days prior to joining
- Must not have received prior radium treatment for prostate cancer
- Must not have previously participated in any other pembrolizumab trial (or received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs)
- Must not have received chemotherapy, targeted small molecule therapy, abiraterone acetate, enzalutamide, or radiation therapy within 2 weeks prior to joining
- Must not have had prior solid organ, bone, or bone marrow transplant

- Other criteria may apply depending on cohort (drug combination), including diagnosis of adenocarcinoma of the prostate, diagnosis of t-NE prostate cancer, previous cancer treatments, and other factors

Age Range

18 - NA

Healthy Volunteers Needed


Duration of Participation

Duration of participation, including follow-up time, may exceed 24 months.

Minors Included



Clinical Trials Information Line: Phone 503-494-1080 or


Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.

Recruitment End


Compensation Provided


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