A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation
A Phase 2 Study of a Checkpoint Inhibitor in Men With Progressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation
Sponsor: VA Office of Research and Development + Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
PSA Decline
Time frame: 12 weeks of therapy
Objective Response Rate
Time frame: First day of Pembrolizumab administration to 6 months after
Secondary Endpoints
Time to Progression of Disease
Overall Survival
Maximum PSA Response
Eligibility Criteria
Inclusion Criteria: * Subject must be 18 years of age or older at the time the Informed Consent is signed. * The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial. * Pathologic diagnosis of prostate cancer of adenocarcinoma or small cell histology. * Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of FDG-PET/CT or scan may be used for eligibility. NaF PET-CT is an alternative to 99mTc bone scan. If lymph node metastasis is the only evidence of metastatic disease, it must be 1.5 cm in short axis and above the level of the iliac bifurcation. Imaging studies for the purpose of determining eligibility must be completed within 60 days of Day 1. * Progressive castration resistant prostate cancer as defined by serum testosterone \< 50 ng/mL and one of the following: * PSA…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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