Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Status:
Completed
Trial end date:
2020-11-30
Target enrollment:
Participant gender:
Summary
This study will investigate the influence of maintenance therapy on progression-free survival
(PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase)
inhibitors and PD-1 antibody pembrolizumab.
In the safety phase I part the optimal dose of pembrolizumab in combination with BRAF
inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be
determined.
In the randomized part 2 different maintenance therapies will be tested for toxicity and
efficacy. Patients with disease control after 6 months of triple therapy will be randomized
to receive 2 different maintenance therapies further on, either continuation of triple
therapy or administration of pembrolizumab alone.