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Association details:
| Biomarker: | BRAF mutation |
|---|---|
| Cancer: | Melanoma |
| Drug: | Mekinist (trametinib) (MEK inhibitor) + Tafinlar (dabrafenib) (BRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
03/31/2020
Excerpt:
Recommendation 2.5….Patients with resected stage IV melanoma may be offered…(in the case of BRAF-mutant disease) dabrafenib plus trametinib…
DOI:
10.1200/JCO.20.00198
Source:
Title:
"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"
Excerpt:
...Tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to anti PD-1 therapy; 4....
Trial ID:
Source:
Title:
LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations
Excerpt:
...to participate in this study: Age ≥18 years Signed written informed consent Histologically confirmed V600E or V600K BRAF mutant melanoma Unresectable Stage III/IV melanoma ECOG PS 0-2...
Trial ID:
More C2 evidence
Source:
Title:
A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib
Excerpt:
...- Participants with prior therapy with targeted therapies specific for mutated BRAF including BRAF and/or MEK inhibitors are eligible provided that there was clinical benefit to prior therapy with these agents as judged by the treating physician....
Trial ID:
Source:
Title:
Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma
Excerpt:
...- Histologically confirmed AJCC Stage IIIB or IIIC (Tx, T1-4, N1b, N2b, N2c, N3, Mo) cutaneous melanoma or unknown primary determined to be BRAF V600 mutation positive, with sufficient nodal or in-transit disease to enable biopsies prior to surgery.Patients must have disease that is measurable per RECIST version 1.1...
Trial ID:
Less C2 evidence
Source:
Title:
1099P - Long-term survival follow-up from the REDUCTOR trial: Neoadjuvant cytoreductive treatment with BRAF/MEK inhibition of prior unresectable regionally advanced melanoma to allow complete surgical resection
Published date:
10/16/2023
Excerpt:
In this single-arm phase II trial, 21 patients with unresectable, BRAF-mutated, locally advanced stage IIIC or oligometastatic stage IV melanoma were treated with neoadjuvant D+T for 8 weeks….The median PFS in all patients was 12.4 months (95% CI 8.68-not reached)....These data confirm favorable long-term survival rates after neoadjuvant D+T and surgical resection without adjuvant therapy in prior unresectable locally advanced BRAF-mutated melanoma patients.
Trial ID:
Source:
Title:
A phase 2 clinical trial on trametinib and low-dose dabrafenib in advanced pretreated BRAFV600/NRASQ61R/K/L wild-type melanoma (TraMel-WT): Interim efficacy and safety results.
Published date:
05/19/2021
Excerpt:
Four out of 6 OR are observed in pts with MAPK-pathway activating mutations (3 class II BRAF and 1 GNAQ mutation)....In this two-stage phase 2 trial, T plus LD-D was found to have promising antitumor activity and acceptable toxicity in pts with advanced pretreated BRAFV600/NRASQ61R/K/L wt melanoma, especially in the presence of identifiable somatic MAPK-pathway activating mutations.
DOI:
10.1200/JCO.2021.39.15_suppl.9529
Trial ID:
Source:
Title:
Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery
Published date:
06/29/2020
Excerpt:
Novartis announced today updated results from the landmark COMBI-AD clinical trial, demonstrating that treatment with Tafinlar® (dabrafenib) and Mekinist® (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma.
