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NCT04104893 · ClinicalTrials.gov registry record · Phase 2

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 Metastatic Castration-Resistant Prostate Cancer, sponsored by VA Office of Research and Development.

Active
Registry status
Phase 2
Development phase
40
Enrollment target
13
Study locations

NCT04104893: Active Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by VA Office of Research and Development.

NCT04104893 is a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 40 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (80% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04104893, a Phase 2 study of Metastatic Castration-Resistant Prostate Cancer, is active but no longer recruiting, sponsored by VA Office of Research and Development.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
13
Study locations

Study Summary

The primary objective is to assess the activity and efficacy of pembrolizumab, a checkpoint inhibitor, in Veterans with metastatic castration-resistant prostate cancer (mCRPC) characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12 (CDK12-/-). The secondary objectives involve determining the frequency with which dMMR and CDK12-/- occur in this patient population, as well as the effects of pembrolizumab on various clinical endpoints (time to PSA progression, maximal PSA response, time to initiation of alternative anti-neoplastic therapy, time to radiographic progression, overall survival, and safety and tolerability). Lastly, the study will compare the pre-treatment and at-progression metastatic tumor biopsies to investigate the molecular correlates of resistance and sensitivity to pembrolizumab via RNA-sequencing, exome-sequencing, selected protein analyses, and multiplexed immunofluorescence.

Primary Outcome

Decline in PSA of 50% or more (PSA50) 12 weeks of therapy (ng/mL)

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

Interventions

  • DRUG Pembrolizumab

Study Locations (13)

California

  • San Francisco VA Medical Center, San Francisco, CA - San Francisco
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles

New York

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY - New York
  • James J. Peters VA Medical Center, Bronx, NY - The Bronx

District of Columbia

  • Washington DC VA Medical Center, Washington, DC - Washington D.C.

Florida

  • Bay Pines VA Healthcare System, Pay Pines, FL - Bay Pines

Illinois

  • Jesse Brown VA Medical Center, Chicago, IL - Chicago

Michigan

  • VA Ann Arbor Healthcare System, Ann Arbor, MI - Ann Arbor

North Carolina

  • Durham VA Medical Center, Durham, NC - Durham

Oregon

  • VA Portland Health Care System, Portland, OR - Portland

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-02-20
Est. Completion 2026-12-31
Phase Phase 2
VA Office of Research and Development

1,668 total trials

What the registry record for NCT04104893 still lists

NCT04104893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.

NCT04104893 lists 13 locations in 11 states (California, New York, District of Columbia).

Frequently Asked Questions

What is clinical trial NCT04104893 about?

NCT04104893 is a clinical study titled "A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation". The primary objective is to assess the activity and efficacy of pembrolizumab, a checkpoint inhibitor, in Veterans with metastatic castration-resistant prostate cancer (mCRPC) characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12 (CDK12-/-). The secondary objec...

What is the current status of trial NCT04104893?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-02-20. Estimated completion is 2026-12-31.

What conditions does trial NCT04104893 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.

What interventions are being tested in trial NCT04104893?

The interventions under investigation include: Pembrolizumab (DRUG).

Who is sponsoring clinical trial NCT04104893?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04104893 being conducted?

This trial has 13 study locations across California, District of Columbia, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04104893's enrollment target sits among peer trials

40 48th of 69 higher than 20 of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04104893, the US trial registry maintained by the National Library of Medicine. NCT04104893 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.