Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04104893
The ClinicalTrials.gov registry entry for NCT04104893 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (80% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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 reports 13 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
RECRUITING · Phase 2
-
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
RECRUITING · Phase 2
-
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
RECRUITING · Phase 2
-
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
RECRUITING · Phase 2
-
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
RECRUITING · Phase 2
-
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.