NCT04059224: TraMel-WT

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

Completed Phase 2 Last updated 26 September 2023

What this trial tests

Phase 2 trial testing Trametinib in Stage IV Melanoma in 45 participants. Completed in 30 June 2023.

Timeline

28 January 2019

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Universitair Ziekenhuis Brussel
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	28 January 2019
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across Belgium

Drugs / interventions tested

• Trametinib (trametinib) — full drug profile →
• Dabrafenib (dabrafenib) — full drug profile →

Conditions studied

• Stage IV Melanoma — all drugs for Stage IV Melanoma →
• Stage III Melanoma — all drugs for Stage III Melanoma →

Sponsor

Universitair Ziekenhuis Brussel — full company profile →

Who can join

18 and older, any sex, with Stage IV Melanoma or Stage III Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-BRAF Mutant Melanoma: Molecular Features and Therapeutical Implications.
   Vanni I, Tanda ET, Dalmasso B, Pastorino L, et al · · 2020 · cited 29× · PMID 32850962 · DOI 10.3389/fmolb.2020.00172
2. A Phase 2 Clinical Trial of Trametinib and Low-Dose Dabrafenib in Patients with Advanced Pretreated <i>NRAS^Q61R/K/L</i> Mutant Melanoma (TraMel-WT).
   Awada G, Schwarze JK, Tijtgat J, Fasolino G, et al · · 2021 · cited 14× · PMID 33921947 · DOI 10.3390/cancers13092010
3. Durable Complete Response of a Recurrent Mesencephalic Glioblastoma Treated with Trametinib and Low-Dose Dabrafenib in a Patient with Neurofibromatosis Type 1.
   Awada G, Serruys D, Schwarze JK, Van De Voorde L, et al · · 2020 · cited 10× · PMID 33082744 · DOI 10.1159/000509773
4. Recent Developments in Targeting RAS Downstream Effectors for RAS-Driven Cancer Therapy.
   Tatli O, Dinler Doganay G. · · 2021 · cited 8× · PMID 34946644 · DOI 10.3390/molecules26247561
5. Novel insights into the pathogenesis and treatment of NRAS mutant melanoma.
   Zhao J, Galvez C, Beckermann KE, Johnson DB, et al · · 2021 · cited 8× · PMID 34485698 · DOI 10.1080/23808993.2021.1938545
6. Treatment-Related Adverse Events in Individuals with BRAF-Mutant Cutaneous Melanoma Treated with BRAF and MEK Inhibitors: A Systematic Review and Meta-Analysis.
   Belloni S, Virgili R, Caruso R, Arrigoni C, et al · · 2025 · cited 1× · PMID 41097682 · DOI 10.3390/cancers17193152
7. The Frontier of Melanoma Treatment: Defeating Immunotherapy Resistance-A Systematic Review.
   Mozga K, Synowiecka O, Rydzyk I, Marek A, et al · · 2026 · PMID 41613791 · DOI 10.32604/or.2025.070505
8. Melanoma: Pathogenesis and Targeted Therapy.
   Fu Y, Liu J, Mo Z, Wang B, et al · · 2026 · PMID 41492362 · DOI 10.1002/mco2.70566