drugset / Trial / NCT05926960

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

NCT05926960

Phase 2 Terminated 38 enrolled Pfizer Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-06-13
Primary completion
2026-02-02
Completion
2026-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Binimetinib Small molecule Oral
Subject Encorafenib Small molecule
Comparator Ipilimumab Monoclonal antibody Intravenous
Comparator Nivolumab Monoclonal antibody Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous

Indications