CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 388 enrolled
Drug / intervention
Pembrolizumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02787005
NCT02787005Phase 2Completed
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Phase II Trial of Pembrolizumab (MK-3475) in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-199)

Merck Sharp & Dohme LLC·interventional·Posted Jun 1, 2016·Updated Nov 21, 2024

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab for Metastatic Castration-resistant Prostate Cancer. Completed, enrolled 388 participants.

Detailed Summary

This is a study of pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer (mCRPC). Participants will be enrolled into one of five cohorts: Cohort 1 (participants with programmed cell death ligand 1 \[PD-L1\]-positive, measurable disease), Cohort 2 (participants with PD-L1 negative, measurable disease), Cohort 3 (participants with bone-metastases and non-measurable disease) post-chemotherapy, Cohort 4 (participants with Response Evaluation Criteria in Solid Tumors version 1.1- \[RECIST 1.1\]-measureable disease) and Cohort 5 (participants with bone metastases only or bone-predominant disease) pre-chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-resistant Prostate Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 1, 2016
Enrollment StartJul 1, 2016
Primary CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.1 years ago

Interventions

Pembrolizumabbiological

Intravenous infusion