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PERSEUS1: Pembrolizumab in mCRPC
NCT03506997Phase 2
Key facts
- Status
- Unknown
- Start
- Nov 2018
- Primary completion
- Sep 2023
- Countries
- 1
- Sponsor
- The Institute of Cancer Research
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
01
Overview
Phase 2, open-label trial of pembrolizumab in metastatic castration-resistant prostate cancer (mCRPC), sponsored by The Institute of Cancer Research. Primary endpoint: Tumour Response at 6 months. Status: unknown.
02
Design
- Study design
- Non-randomizedOpen-labelSingle group
03
Who it enrols
Male patients aged 18+ with metastatic castration-resistant prostate cancer who have progressed on prior therapies (e.g., Abiraterone, Enzalutamide, Docetaxel) and have high mutational load, MSI-high, or DNA repair defects. Patients must have adequate organ function and ECOG 0-2. Excludes patients with autoimmune disease, prior checkpoint inhibitor therapy, or active HIV/Hepatitis.
04
Endpoints
Primary
Tumour Response
Secondary
Radiological Progression-Free Survival
Time to Radiological Progression
Progression-Free Survival
Time to PSA Progression
Duration of PSA Response
Overall Survival
Safety and Tolerability
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