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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Pfizer
Study ID
NCT04657991
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Encorafenib — DRUG
    Encorafenib
  • Binimetinib — DRUG
    Binimetinib
  • Pembrolizumab — DRUG
    Pembrolizumab

Study Details

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.

Key Dates

Start date
Jan 15, 2021
Status verified
Apr 2026
Primary completion
Jan 12, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
257 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Triplet Arm
    Encorafenib and Binimetinib in combination with Pembrolizumab
  • Active Comparator: Control Arm
    Pembrolizumab

Primary Outcome Measure

Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: First 2 Cycles of Treatment (cycles are 21 days) ]

Locations (17)

FacilityCityStateZIPSite coordinators
AdventHealth Hematology and OncologyOrlandoFlorida32804-
AdventHealth Orlando Infusion CenterOrlandoFlorida32804-
AdventHealth Orlando, Investigational Drug ServicesOrlandoFlorida32804-
Adventist Health System/Sunbelt, Inc.OrlandoFlorida32803-
The University of Kansas Clinical Research CenterFairwayKansas66205-
The University of Kansas Cancer Center - Overland ParkOverland ParkKansas66210-
KU Eye CenterPrairie VillageKansas66208-
The University of Kansas Cancer CenterWestwoodKansas66205-
The University of Kansas Cancer Center - Investigational Drug ServicesWestwoodKansas66205-
Massachusetts General HospitalBostonMassachusetts02114-
Ophthalmic Consultants of Boston Inc (OCB)BostonMassachusetts02114-
University of Cincinnati Medical CenterCincinnatiOhio45219-
University of Cincinnati Medical CenterWest ChesterOhio45069-
West Chester HospitalWest ChesterOhio45069-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Tennessee Oncology, PLLCNashvilleTennessee37203-

Related coverage on Hipa.ai

Find similar trials in Orlando, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
AdventHealth Hematology and Oncology· Orlando, FLAdventHealth Orlando Infusion Center· Orlando, FLAdventHealth Orlando, Investigational Drug Services· Orlando, FLAdventist Health System/Sunbelt, Inc.· Orlando, FLThe University of Kansas Clinical Research Center· Fairway, KSThe University of Kansas Cancer Center - Overland Park· Overland Park, KS

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