TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma

Sponsor
Universitair Ziekenhuis Brussel
Study ID
NCT04059224
Phase
PHASE2
Status
Completed

Conditions

  • Stage III Melanoma
  • Stage IV Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trametinib — DRUG
    Trametinib 2 mg once a day by mouth.
  • Dabrafenib — DRUG
    Dabrafenib 50 mg twice a day by mouth. Dabrafenib can be uptitrated to 150 mg twice a day in case of dose-limiting trametinib-associated skin toxicity.

Study Details

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.

Key Dates

Start date
Jan 28, 2019
Status verified
Sep 2023
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: advanced BRAF V600 wild-type/NRAS-mutant melanoma
    Patients will be treated with trametinib 2 mg once a day and dabrafenib 50 mg twice a day until disease progression, unacceptable treatment related toxicity or patient's refusal to continue study treatment.
  • Experimental: Arm B: advanced BRAF V600 wild-type/NRAS wild-type melanoma
    Patients will be treated with trametinib 2 mg once a day and dabrafenib 50 mg twice a day until disease progression, unacceptable treatment related toxicity or patient's refusal to continue study treatment.

Primary Outcome Measure

Arm A: objective response rate on trametinib and dabrafenib [ Time Frame: 2 years ]

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