Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
Sponsor: Weill Medical College of Cornell University + United States Department of Defense, Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Proportion of patients with dose-limiting toxicity (DLT) following treatment with pembrolizumab and 225Ac-J591
Time frame: From visit 1 through 12 weeks on study
Determination of optimal dose of 225Ac-J591 for phase II
Time frame: From visit 1 through 12 weeks on study
Change in composite response rate of pembrolizumab and ARPI with or without 225Ac-J591
Time frame: Will be collected at the time of visit 1 and up to 100 months
Secondary Endpoints
Change in overall survival following treatment
Change in biochemical progression-free survival
Change in radiographic progression-free survival
Eligibility Criteria
Inclusion Criteria: * Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate adenocarcinoma. * A male participant must agree to use a contraception during the treatment period and for at least 4 months after the last dose of study treatment and refrain from donating sperm during this period. * Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions * Evaluable for response with at least one of the following: * Measurable disease by RECIST 1.1 * Detectable (\>0) CTC by CellSearch * PSA of at least 2 ng/dL * ECOG performance status of 0-1 * Have serum testosterone ≤ 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy. * …
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