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NCT04657991 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
A Phase 3 study of Melanoma, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 257
- Enrollment target
- 20
- Study locations
NCT04657991: Active Phase 3 study of Melanoma, sponsored by Pfizer.
NCT04657991 is a Phase 3 study of Melanoma that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 257 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04657991, a Phase 3 study of Melanoma, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 257 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Primary Outcome
A DLT is defined as any adverse event or laboratory value that is assessed as unrelated to disease, disease progression, intercurrent illness or concomitant medications/therapies occurring within the first 2 cycles of treatment.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Binimetinib
- DRUG Encorafenib
Study Locations (20)
Kansas
- The University of Kansas Clinical Research Center - Fairway
- University of Kansas Medical Center Research Institute - Kansas City
- The University of Kansas Cancer Center - Overland Park - Overland Park
- KU Eye Center - Prairie Village
- The University of Kansas Cancer Center - Investigational Drug Services - Westwood
- The University of Kansas Cancer Center - Westwood
Florida
- AdventHealth Hematology and Oncology - Orlando
- AdventHealth Orlando Infusion Center - Orlando
- AdventHealth Orlando, Investigational Drug Services - Orlando
- AdventHealth Orlando - Orlando
Tennessee
- University of Tennessee Medical Center - Knoxville
- Sarah Cannon Research Institute - Nashville
- Tennessee Oncology, PLLC - Nashville
Massachusetts
- Massachusetts General Hospital - Boston
- Ophthalmic Consultants of Boston Inc (OCB) - Boston
Ohio
- University of Cincinnati Medical Center - Cincinnati
- University of Cincinnati Medical Center - West Chester
Buenos Aires
- Instituto Alexander Fleming - CABA
Río Negro Province
- Clinica Viedma S. A - Viedma
Other
- Medizinische Universität Graz - Graz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 3 |
What the registry record for NCT04657991 still lists
NCT04657991 is an interventional study that assigns participants to a tested intervention. The registered 257 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04657991 names 20 study sites across 8 states, led by Kansas, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04657991 about?
NCT04657991 is a clinical study titled "A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma". The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called "BRAF"; and...
What is the current status of trial NCT04657991?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 257 participants. The study started on 2021-01-15. Estimated completion is 2026-08-31.
What conditions does trial NCT04657991 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04657991?
The interventions under investigation include: Pembrolizumab (DRUG), Binimetinib (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04657991?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04657991 being conducted?
This trial has 20 study locations across Florida, Kansas, Massachusetts, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT04657991's enrollment target sits among peer trials
257 59th of 266 higher than 208 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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
-
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
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Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
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A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
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