Trial of Pembrolizumab in Metastatic Castration Resistant Prostate Cancer
NCT03506997 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-07-22
Summary
PERSEUS1 is an open-label, single arm, phase II trial evaluating the efficacy of Pembrolizumab in metastatic castration resistant prostate cancer (mCRPC) patients (Part A) with a biomarker enrichment stage (Part B) if efficacy is shown in part A.
Conditions
- Castration-resistant Prostate Cancer
Interventions
- DRUG
-
Pembrolizumab 200mg given as a 30 minute intravenous (IV) infusion, on day 1 of each 3 week cycle. Patients may continue with pembrolizumab treatment as long as they remain free from intolerable toxicity for a maximum of two years, if in the Investigator's opinion they are receiving clinical benefit, and/or they do not meet any discontinuation criteria.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Institute of Cancer Research, United Kingdom
lead OTHER
Principal Investigators
-
Johann de Bono · The Institute of Cancer Research/The Royal Marsden NHSFT
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-27
- Primary Completion
- 2023-09-01
- Completion
- 2025-09-01
Countries
- United Kingdom
Study Locations
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