A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma (NCT04657991)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Adventist Health System/Sunbelt, Inc. — Orlando, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (143 Sites)
Showing the first 25 of 143 sites.
- Adventist Health System/Sunbelt, Inc. — Orlando, Florida
- AdventHealth Hematology and Oncology — Orlando, Florida
- AdventHealth Orlando Infusion Center — Orlando, Florida
- AdventHealth Orlando, Investigational Drug Services — Orlando, Florida
- The University of Kansas Clinical Research Center — Fairway, Kansas
- The University of Kansas Cancer Center - Overland Park — Overland Park, Kansas
- KU Eye Center — Prairie Village, Kansas
- The University of Kansas Cancer Center - Investigational Drug Services — Westwood, Kansas
- The University of Kansas Cancer Center — Westwood, Kansas
- Massachusetts General Hospital — Boston, Massachusetts
- Ophthalmic Consultants of Boston Inc (OCB) — Boston, Massachusetts
- University of Cincinnati Medical Center — Cincinnati, Ohio
- University of Cincinnati Medical Center — West Chester, Ohio
- West Chester Hospital — West Chester, Ohio
- University of Tennessee Medical Center — Knoxville, Tennessee
- Sarah Cannon Research Institute — Nashville, Tennessee
- Tennessee Oncology, PLLC — Nashville, Tennessee
- Instituto Alexander Fleming — CABA, Buenos Aires
- Clinica Viedma S. A — Viedma, Río Negro Province
- Medizinische Universität Graz — Graz,
- Cliniques universitaires Saint-Luc — Brussels,
- Instituto de Oncologia do Paraná - IOP Matriz Mateus Leme — Curitiba, Paraná
- Instituto de Oncologia do Paraná - IOP Oncoville — Curitiba, Paraná
- Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA — Rio de Janeiro, Rio de Janeiro
- Hospital de Clínicas de Passo Fundo — Passo Fundo, Rio Grande do Sul
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma
- Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
- An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) — Tucson, Arizona
- Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. — CABA, Buenos Aires
- Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients — Santa Monica, California
- NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma — Boston, Massachusetts
Explore by condition: All Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.