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A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

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NCT04657991

Sponsored by Pfizer (industry) · PFE — their whole pipeline →. With Merck Sharp & Dohme LLC.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
257actual
Sites
143
Countries
Argentina, Austria, Belgium +24

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-01-15actualWhen the study began enrolling
Primary completion2026-01-12actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-08-31estimatedThe whole study's end, after follow-up
First posted2020-12-08actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-04-07actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Melanoma

Interventions

  • Drug: Encorafenib — also filed as BRAFTOVI
  • Drug: Binimetinib — also filed as MEKTOVI
  • Drug: Pembrolizumab — also filed as KEYTRUDA

Primary outcomes

what the primary-completion date above is the date OF
Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs)
measured First 2 Cycles of Treatment (cycles are 21 days)
Phase 3: Objective Response (OR) by Blinded Independent Central Review (BICR)
measured Time from the date of randomization until documented PD, start of subsequent anticancer therapy, or death due to any cause (approximately every 9 weeks).

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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