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NCT04191096 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)
A Phase 3 study of Metastatic Hormone-sensitive Prostate Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,251
- Enrollment target
- 20
- Study locations
NCT04191096 is a Phase 3 study of Metastatic Hormone-sensitive Prostate Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,251 participants, above the 454-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (176% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT04191096, a Phase 3 study of Metastatic Hormone-sensitive Prostate Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,251 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Placebo
- DRUG Enzalutamide
- DRUG Androgen Deprivation Therapy (ADT)
Study Locations (20)
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270) - New York
- Weill Cornell Medical College ( Site 0263) - New York
- Associated Medical Professionals of NY ( Site 0251) - Syracuse
Alaska
- Alaska Clinical Research Center ( Site 0274) - Anchorage
- Providence Alaska Medical Center ( Site 0276) - Anchorage
California
- City of Hope Medical Center ( Site 0217) - Duarte
- UCLA Hematology/Oncology - Santa Monica ( Site 0241) - Los Angeles
Connecticut
- Hartford HealthCare Medical Group ( Site 0212) - Manchester
- Smilow Cancer Center at Yale-New Haven ( Site 0250) - New Haven
Illinois
- The University of Chicago ( Site 0264) - Chicago
- Springfield Clinic [Springfield, IL] ( Site 0240) - Springfield
Colorado
- University of Colorado, Anschutz Cancer Pavilion ( Site 0236) - Aurora
District of Columbia
- Sibley Memorial Hospital ( Site 0275) - Washington D.C.
Georgia
- Winship Cancer Institute of Emory University ( Site 0209) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,251 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2026-03-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04191096
The ClinicalTrials.gov registry entry for NCT04191096 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,251 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 454-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (176% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Hormone-sensitive Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04191096 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Alaska, California.
Frequently Asked Questions
What is clinical trial NCT04191096 about?
NCT04191096 is a clinical study titled "Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)". This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamid...
What is the current status of trial NCT04191096?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,251 participants. The study started on 2020-02-12. Estimated completion is 2026-03-27.
What conditions does trial NCT04191096 study?
This clinical trial studies the following conditions: Metastatic Hormone-sensitive Prostate Cancer.
What interventions are being tested in trial NCT04191096?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (OTHER), Enzalutamide (DRUG), Androgen Deprivation Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT04191096?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04191096 being conducted?
This trial has 20 study locations across Alaska, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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