Study of Pembrolizumab (MK-3475) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Chemotherapy (MK-3475-199/KEYNOTE-199)

Official Title

Phase II Trial of Pembrolizumab (MK-3475) in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Chemotherapy (KEYNOTE-199)

Summary:

This is a study of pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel-based chemotherapy. Participants will be enrolled into one of three cohorts: Cohort 1 (participants with programmed cell death ligand 1 [PD-L1]-positive, measurable disease), Cohort 2 (participants with PD-L1 negative, measurable disease), or Cohort 3 (participants with bone-metastases and non-measurable disease)

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 assessed by central imaging vendor (Cohorts 1 and 2 only)

• Disease Control Rate (DCR) (All Cohorts)
• Prostate-specific Antigen (PSA) response rate (All Cohorts)
• Percentage of participants who experience an adverse event (AE)
• Percentage of participants who discontinue study drug due to an AE

View this trial on ClinicalTrials.gov