Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

Official Title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND 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

Details

This study will compare the efficacy, safety, and tolerability of encorafenib and binimetinib plus pembrolizumab (Triplet Arm) versus placebo plus pembrolizumab (Control Arm) in participants with metastatic or unresectable locally advanced BRAF V600E/K mutation-positive melanoma. The study will have an open-label safety lead-in (SLI) phase to determine the safety recommend Phase 3 dose (RP3D) and pharmacokinetics (PK) of encorafenib and binimetinib plus pembrolizumab combination therapy prior to initiation of the randomized Phase 3 part of the study. Two dose levels of encorafenib in combination with binimetinib plus pembrolizumab will be explored in parallel. A minimum of 12 evaluable participants will be enrolled per dose level. During the double-blind randomized Phase 3 part of the study, approximately 216 eligible participants will be randomized in a 1:1 ratio to the Triplet Arm (at RP3D determined in the SLI) or Control Arm (approximately 108 participants per arm). Randomization will be stratified by prior systemic adjuvant therapy and stage of disease by AJCC (ED8).

Keywords

Melanoma, BRAF V600E/K Melanoma, BRAF, Advanced Melanoma, Metastatic Melanoma, Skin Cancer, Advanced Skin Cancer, Starboard, Stage 3 Melanoma, Stage 4 Melanoma, BRAF Melanoma, Pembrolizumab, Encorafenib, Binimetinib

Eligibility

Locations

  • UCLA - Hematology/Oncology - Administrative Office
    Los Angeles California 90024 United States
  • Ronald Reagan UCLA Medical Center Drug Information Center , Dept. of Pharmaceutical Services (Drug
    Los Angeles California 90095 United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center, Dept. of Pharmaceutical Services (Main O
    Los Angeles California 90095 United States
  • UCLA Hematology/Oncology - Westwood (Building 100)
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
STARBOARD STUDY C4221016
ID
NCT04657991
Phase
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
About 256 people participating
Last Updated