^
    Back
    Association details:
    Biomarker:BRAF mutation
    Cancer:Melanoma
    Drug:Mekinist (trametinib) (MEK inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    A trial to assess efficacy in patients with advanced pretreated BRAFV600 wild-type melanoma

    Excerpt:
    ...Absence of a BRAF V600 mutation as determined by a validated test 5. ...
    Trial ID:
    2018-004003-39
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...- Absence of a BRAF V600 mutation as determined by a validated test....
    Trial ID:
    TraMel-WT
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations

    Excerpt:
    ...- BRAF mutation in loci other than V600 (BRAF nonV600 MUT) or BRAF fusion detected by genetic testing of the primary tumor or regional/distant metastasis...
    Trial ID:
    NCT02296112
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

    Excerpt:
    ...BRAF mutation-positive and wild-type tumors are allowed....
    Trial ID:
    NCT02300935
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Phase 1B Clinical Trial of Trametinib Plus Digoxin in Patients With Unresectable or Metastatic BRAF Wild-type Melanoma

    Excerpt:
    ...BRAF wild-type confirmed, and NRAS mutation assessed....
    Trial ID:
    NCT02138292
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Open-label Study to Investigate the Safety, PK, and Pharmacodynamics of GSK1120212 in Subjects With Solid Tumors or Lymphoma

    Excerpt:
    ...- Histologically or cytologically confirmed diagnosis of melanoma, pancreatic, colorectal cancer (CRC), non-small cell lung cancer, or other tumor with BRAF mutation....
    Trial ID:
    NCT00687622
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    A randomised phase 2 study of paclitaxel with or without GSK1120212 in advanced wt BRAF melanoma

    Excerpt:
    ...Able to provide evidence from an accredited laboratory of wt BRAF status for their melanoma, or ascertainment of wt BRAF status from a sample of melanoma provided for mutational analysis in Oxford (phase 2 part only). ...
    Trial ID:
    2011-002545-35
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Lancet Oncol
    Title:

    Activity of the oral MEK inhibitor trametinib in patients with advanced melanoma: a phase 1 dose-escalation trial

    Excerpt:
    97 patients with melanoma were enrolled, including 81 with cutaneous or unknown primary melanoma (36 BRAF mutant, 39 BRAF wild-type, six BRAF status unknown), and 16 with uveal melanoma....Of 36 patients with BRAF mutations, 30 had not received a BRAF inhibitor before; two complete responses (both confirmed) and ten partial responses (eight confirmed) were noted in this subgroup (confirmed response rate, 33%).
    DOI:
    10.1016/S1470-2045(12)70269-3
    Trial ID:
    NCT00687622