TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
This phase 2 trial will investigate the efficacy and safety of trametinib and dabrafenib in
patients with advanced BRAF V600 (v-Raf murine sarcoma viral oncogene homolog B) wild-type
melanoma (stratified according to BRAF V600 wild-type/NRAS (neuroblastoma Ras viral oncogene
homolog) mutant and BRAF V600 wild-type/NRAS wild-type melanoma patients) that have been
pretreated and progressed following treatment with PD-1- (programmed cell death-1) and
CTLA-4-blocking (cytotoxic T-lymphocyte-associated antigen 4) immune checkpoint inhibitors.
The investigators hypothesize that treatment with trametinib will result in objective
antitumor activity. In order to improve the tolerability and optimize the dose intensity of
trametinib, a minimal dose of dabrafenib will be added to prevent and manage
trametinib-related skin toxicity.