Melanoma - trametinib - BRAF mutation

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

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

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