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NCT04104893PHASE2ACTIVE_NOT_RECRUITING

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

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Key Facts

Study type
INTERVENTIONAL
Conditions
Metastatic Castration Resistant Prostate Cancer
Interventions
Pembrolizumab
Enrollment
40 participants
Primary completion
Feb 2026
Study completion
Dec 2026
First posted
Sep 2019
Last updated
Feb 2026

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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Source

Open on ClinicalTrials.gov