CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200mgfrom 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/NCT03248570
NCT03248570Phase 2Completed
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Phase 2 Open Label Study of Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects

University of California, San Francisco·interventional·Posted Aug 14, 2017·Updated Nov 20, 2024

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Chemotherapy for Castration Resistant Prostatic Cancer and Metastatic Prostate Cancer. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCastration Resistant Prostatic Cancer, Metastatic Prostate Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 14, 2017
Enrollment StartFeb 20, 2018
Primary CompletionSep 28, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 8.9 years ago

Interventions

Pembrolizumabdrug

All subjects will receive pembrolizumab 200mg IV every 3 weeks until disease progression or unacceptable toxicity.

Chemotherapydrug

At time of progression, all subjects will also have the option of receiving taxane-based chemotherapy followed by repeat pembrolizumab for those who have a clinical response to chemotherapy. Chemotherapy regimen will be at the discretion of the treating physician, and may consist of docetaxel or cabazitaxel with or without a platinum agent (e.g. carboplatin). A minimum of 4 cycles and a maximum of 8 cycles of chemotherapy will be given.