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Dabrafenib, trametinib, and Ipilimumab are each indicated for treatment of patients (pts) with metastatic melanoma (Dabrafenib+trametinib in BRAF V600 mutation–positive metastatic melanoma). Dabrafenib and trametinib can be safely combined and prolong progression-free survival compared with monotherapy. Combining Dabrafenib+trametinib with the CTLA-4 antibody Ipi has the potential to improve treatment outcomes, but the safety profile is unknown. A recent report suggested caution in combining the BRAF inhibitor vemurafenib (V) with Ipilimumab; V+Ipilimumab resulted in G3 elevations of ALT in 6/10 pts leading to study discontinuation (NEJM2013 368; 14). The present study was designed to characterize the safety of Dabrafenib±trametinib+Ipilimumab, select recommended phase 2 doses (RP2Ds), and report efficacy.

journal of translational medicine

Combining targeted and immunotherapy: BRAF inhibitor dabrafenib (D) ± the MEK inhibitor trametinib (T) in combination with ipilimumab (Ipi) for V600E/K mutation-positive unresectable or metastatic melanoma (MM)