Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Castration Resistant Prostatic Cancer
- Metastatic Prostate Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: After determination of DNA damage repair status, subjects will be assigned to one of two treatment groups: Group 1 (DNA damage repair proficient group): Twenty-five subjects Group 2 (DNA damage repair deficient group): Twenty-five subjects All subjects will receive pembrolizumab 200mg IV every 3 weeks until disease progression or unacceptable toxicity.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
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. All subjects will receive pembrolizumab 200mg intravenously (IV) every 3 weeks until disease progression or unacceptable t...
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. All subjects will receive pembrolizumab 200mg intravenously (IV) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint of the study is objective response rate (ORR) according to immune-mediated response criteria (irRC).
Tracking Information
- NCT #
- NCT03248570
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Principal Investigator: Lawrence Fong, MD University of California, San Francisco
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