A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma

Sponsor
Pfizer
Study ID
NCT05926960
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • encorafenib — DRUG
    encorafenib
  • binimetinib — DRUG
    binimetinib
  • pembrolizumab — DRUG
    pembrolizumab
  • ipilimumab — DRUG
    ipilimumab
  • nivolumab — DRUG
    nivolumab

Study Details

The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment of melanoma. Melanoma is a type of cancer that starts in the cells that give color to your skin. The study is seeking participants who: * have advanced or metastatic melanoma (has spread to other parts of the body); * have a certain abnormal gene called "BRAF". * have taken nivolumab or pembrolizumab treatment before this study. Participants will either receive: * pembrolizumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic. Participants will also receive encorafenib and binimetinib by mouth every day at home, * or will receive ipilimumab and nivolumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic 4 times. This will be followed by nivolumab given by intravenous infusion every 4 weeks at the study clinic. Both pembrolizumab and nivolumab will be given for a maximum of around 2 years. However, there is no time limit for encorafenib and binimetinib treatment. The study team will see how each participant is doing after receiving the study treatments during regular visits to the study clinic.

Key Dates

Start date
Jun 13, 2023
Status verified
Mar 2026
Primary completion
Feb 2, 2026
Completion
Feb 2, 2026

Study Design

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

Arms

  • Experimental: Triplet
    encorafenib and binimetinib in combination with pembrolizumab
  • Active Comparator: Doublet
    ipilimumab and nivolumab

Primary Outcome Measure

Objective Response Rate (ORR) is defined as the proportion of participants in each treatment arm with a confirmed best overall response of either Complete Response (CR) or Partial Response (PR), as determined by investigator assessment per RECIST v1.1 [ Time Frame: Time from the date of randomization to the earliest date disease progression, or start of subsequent anticancer therapy, or death due to any cause (assessed up to approximately 48 months). ]

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