Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
A Phase 2 Study of Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Metastatic Castration Resistant Prostate Cancer
Sponsor: University of California, San Francisco + Merck Sharp & Dohme LLC, Prostate Cancer Foundation
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Median radiographic progression-free survival (rPFS) at 12 months
Time frame: 12 months
Secondary Endpoints
Overall median radiographic rPFS
Objective response rate (ORR)
Median duration of objective response (DOR)
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed prostate adenocarcinoma that is progressive metastatic castration-resistant prostate cancer by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria at the time of study entry. 2. Male participants who are at least 18 years of age on the day of signing informed consent. 3. Castrate level of serum testosterone at study entry (\< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study. 4. Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide. 5. Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade \<= 1 (except for any grade alopecia and grade \<= 2 neuropathy). 6. Prior radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from s…
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