Prof. Dr. med. Dirk Schadendorf, Universitätsklinikum Essen speaks about the ESMO 2021 Abstract – 1091TiP – STARBOARD: Randomized phase III study of encorafenib (enco) + binimetinib (bini) + pembrolizumab (pembro) for first-line treatment of metastatic or unresectable locally advanced BRAF V600-mutant melanoma.
1091TiP –
Context:
BRAF V600 mutations are found in around half of all individuals with metastatic melanoma, and they accelerate melanoma progression by activating the MAPK pathway in a constant state. BRAF inhibitors (BRAFi) + MEK inhibitors (MEKi) (eg, enco + bini) and immune checkpoint inhibitors are now recommended treatments for metastatic or unresectable BRAF V600-mutant melanoma (CPIs; eg, pembro). BRAF V600-mutant tumors may be more sensitive to CPIs if BRAFi and MEKi are present. The goal of STARBOARD is to compare the effectiveness, safety, and tolerability of enco + bini + pembro vs pembro alone in the treatment of metastatic or unresectable locally advanced BRAF V600-mutant melanoma.
Design of the experiment:
STARBOARD is a phase III study with a safety lead-in that is randomized, double-blind, and placebo-controlled (SLI). In the SLI and phase III studies, about 24 and 600 patients will be included, respectively; phase III randomization will be stratified by past systemic adjuvant treatment and disease stage. Patients must have histologically proven metastatic or unresectable cutaneous melanoma with BRAF V600E/K mutation (by local laboratory assay); detectable disease (RECIST v1.1); ECOG performance level 0 or 1; and sufficient bone marrow, hepatic, and renal function. Patients must not have had first-line systemic therapy in the past. Prior adjuvant treatment with BRAFi and/or MEKi, as well as anti"“PD-1 or anti"“CTLA-4 antibodies, is allowed. Except for individuals with three brain lesions (either previously treated, asymptomatic, and stable for 28 days prior to inclusion; or untreated, asymptomatic, and each 5 mm), those with prior or present symptomatic brain metastases will be excluded. The table below lists the study’s treatments and outcomes. Enrollment started on February 11, 2021.
Clinical trial identification
NCT04657991.