A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
Public ClinicalTrials.gov record NCT04657991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE METASTATIC OR UNRESECTABLE LOCALLY ADVANCED MELANOMA
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04657991
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 257 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 15, 2021 (Actual)
- Primary completion
- Oct 30, 2026 (Estimated)
- Completion
- Oct 30, 2026 (Estimated)
- Last update posted
- Sep 3, 2026
2021 – 2026
United States locations
- U.S. sites
- 27
- U.S. states
- 5
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AdventHealth Hematology and Oncology | Orlando | Florida | 32804 | — |
| AdventHealth Orlando Infusion Center | Orlando | Florida | 32804 | — |
| AdventHealth Orlando, Investigational Drug Services | Orlando | Florida | 32804 | — |
| The University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | — |
| The University of Kansas Cancer Center - Overland Park | Overland Park | Kansas | 66210 | — |
| KU Eye Center | Prairie Village | Kansas | 66208 | — |
| The University of Kansas Cancer Center - Investigational Drug Services | Westwood | Kansas | 66205 | — |
| The University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Ophthalmic Consultants of Boston Inc (OCB) | Boston | Massachusetts | 02114 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| West Chester Hospital | West Chester | Ohio | 45069 | — |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | — |
| Tennessee Oncology PLLC | Franklin | Tennessee | 37067 | — |
| Tennessee Oncology PLLC | Gallatin | Tennessee | 37066 | — |
| Tenessee Oncology, PLLC | Hendersonville | Tennessee | 37075 | — |
| Tennessee Oncology PLLC | Hermitage | Tennessee | 37076 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Tennessee Oncology PLLC | Lebanon | Tennessee | 37090 | — |
| Tennessee Oncology PLLC | Murfreesboro | Tennessee | 37129 | — |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37205 | — |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37207 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | — |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | — |
| Tennessee Oncology PLLC | Smyrna | Tennessee | 37167 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 124 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04657991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04657991 live on ClinicalTrials.gov.