Active — Not RecruitingPhase 3

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

United States257 participantsStarted 2021-01-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female participants ≥ 18 years at the time of informed consent. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition. * Presence of at least 1 measurable lesion as detected by radiological and/or photographic methods according to RECIST v1.1. * ECOG performance status 0 or 1. * Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay (eg, US FDA-approved test, CE-marked \[European conformity\] in vitro diagnostic in EU countries, or equivalent), obtained during the course of normal clinical care, in a CLIA- or similarly certified laboratory. * Submission of adequate tumor tissue (archival or newly obtained; block or slides to the sponsor central laboratory(ies) during the screening period and prior to enrollment (SLI)/randomization (Phase 3). * Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma. * Adequate bone marrow function, hepatic and renal function. * Capable of giving signed informed consent. Exclusion Criteria * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or …

What they're measuring

Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs)

Timeframe: First 2 Cycles of Treatment (cycles are 21 days)

Phase 3: Objective Response (OR) by Blinded Independent Central Review (BICR)

Timeframe: Time from the date of randomization until documented PD, start of subsequent anticancer therapy, or death due to any cause (approximately every 9 weeks).

Trial details

NCT IDNCT04657991

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-12

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