GlaxoSmithKline Launches Combination Trials for Metastatic Melanoma
Phase 3/4 Trials
GlaxoSmithKline has begun a Phase III program evaluating the combination of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib in patients with BRAF mutation-positive metastatic cutaneous melanoma. The COMBI-d (Combination of MEK and BRAF Inhibitors versus dabrafenib) trial is a Phase III trial of the combination in patients with BRAF V600E or V600K mutation-positive metastatic cutaneous melanoma. This global trial will evaluate the efficacy of the two investigational agents versus dabrafenib single-agent therapy in stopping or slowing the progression of metastatic melanoma (Progression Free Survival). COMBI-v (Combination of MEK and BRAF Inhibitors versus vemurafenib), a Phase III trial of the combination in patients with BRAF V600E or V600K mutation-positive metastatic cutaneous melanoma, will evaluate whether combining the two investigational agents is better than single-agent therapy with vemurafenib in improving the overall survival of patients with metastatic melanoma (Overall survival). Both studies will evaluate the safety profile of the dabrafenib-trametinib combination.