The STARBOARD Study
Research type
Research Study
Full 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
IRAS ID
301490
Contact name
Jemma Capuozzo
Contact email
Sponsor organisation
Pfizer
Eudract number
2020-004850-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
113850, US IND Number
Duration of Study in the UK
3 years, 4 months, 16 days
Research summary
Melanoma is the most lethal form of skin cancer, due to its tendency to metastasize to vital organs, including the brain, lungs, liver and other visceral sites. The number of melanoma cases worldwide as of 2018 was estimated to be 287,723, with 60,712 deaths and is the 19th most commonly occurring cancer in men and women.
The purpose of the study is to compare the efficacy of encorafenib (a BRAF inhibitor) and binimetinib (a MEK inhibitor) plus pembrolizumab (anti-PD-1 antibody) versus placebo plus pembrolizumab in participants with metastatic or unresectable locally advanced BRAF V600E/K-mutant melanoma. Current standard-of-care therapies include immunotherapies with an anti-PD-1 antibody, either alone or in combination with anti-CTLA-4 therapy and the option of targeted therapies with various BRAFi + MEKi combinations. These therapeutic approaches, however, have limitations, including a limited duration of benefit in subsets of BRAF-mutant melanoma patients and a lower overall response rate.
Since targeted therapy and checkpoint inhibitors have separate mechanisms of action and different response patterns, the combined BRAFi + MEKi + anti-PD-1/-L1 has demonstrated enhanced durability of anti-tumour responses induced by BRAF/MEK inhibition and superiority of Progression Free Survival over BRAFi + MEKi alone in patients with BRAF V600 mutation–positive advanced melanoma. This supports the investigation of the triplet combination of encorafenib and binimetinib plus pembrolizumab.
This study has an open-label safety lead-in phase to determine the recommended phase 3 dose of encorafenib and binimetinib when given in combination with pembrolizumab. A minimum of 12 participants will be enrolled per dose level. During the double-blind randomised Phase 3 part of the study, approximately 600 participants will be randomised in a 1:1 ratio to the Triplet Arm or Control Arm (placebo plus pembrolizumab). The primary objective of the Phase 3 part of the study is to compare the efficacy of Triplet arm vs the Control arm with respect to Progression Free Survival. Encorafenib and binimetinib will be administered orally by a tablet or capsule once or twice daily and pembrolizumab via IV solution once every 3 weeks.
The study is sponsored by Pfizer, Inc. and will take place in 27 countries.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
21/SC/0291
Date of REC Opinion
2 Nov 2021
REC opinion
Further Information Favourable Opinion