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", andhas not received prior treatment.
Aim of the study
The aim of the 2nd part of the study (the part of the study you can take part in) is to see if the combination of encorafenib and binimetinib with pembrolizumab is more effective in treating your cancer than pembrolizumab alone (a standard of care for advanced melanoma). By administering encorafenib and binimetinib together with pembrolizumab, the researchers hope to find out whether the investigational drugs work better together as a combination.
Who can take part?
Patients with BRAF V600E/K mutation-positive metastatic or unresectable locally advanced melanoma
Procedure
This study consists of two parts: Part 1 (already completed): a preliminary safety study to determine the safest and most tolerable dose level of encorafenib and binimetinib in combination with pembrolizumab. Part 2 (in which you will be asked to participate): a randomized part in which you would be randomly assigned to one of two treatment groups. They would receive either encorafenib and binimetinib in combination with pembrolizumab at the dose selected in the preliminary safety study or a placebo (no drug) for encorafenib and binimetinib in combination with pembrolizumab.
Compensation
None
Original study name
A randomized, double-blind, phase 3 study of encorafenib and binimetinib plus pembrolizumab versus placebo plus pembrolizumab in participants with BRAF V600E/K mutation-positive metastatic or unresectable locally advanced melanoma
BASEC number
2021-00536
Financial support from
Pfizer