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Association details:
| Biomarker: | BRAF V600 |
|---|---|
| Cancer: | Melanoma |
| Drug: | Tafinlar (dabrafenib) (BRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
08/26/2013
Excerpt:
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Source:
Title:
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Excerpt:
...- Has advanced (unresectable Stage III) or metastatic (Stage IV) melanoma that is BRAF mutation positive (V600E)...
Trial ID:
Source:
Title:
A Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects with BRAF Mutation-Positive Metastatic Melanoma to the Brain
Excerpt:
...5.Histologically confirmed metastatic melanoma (Stage IV), carrying BRAF V600E- or V600K-mutation as determined by central testing. ...
Trial ID:
More C2 evidence
Source:
Title:
[18F]Dabrafenib Molecular Imaging in Melanoma Brain Metastasis
Excerpt:
...BRAF mutation-positive (V600 E/K) melanoma as determined by standardized genetic testing....
Trial ID:
Source:
Title:
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
Excerpt:
...- Histologically confirmed metastatic melanoma (Stage IV), carrying BRAF V600E- or V600K-mutation....
Trial ID:
Source:
Title:
A study comparing Dacarbazine (DTIC) to GSK2118436 in BRAF mutant advanced or metastatic melanoma
Excerpt:
...Histologically confirmed advanced (unresectable Stage III) or metastatic melanoma (Stage IV) and BRAF mutation-positive (V600 E) melanoma as determined via central testing with a BRAF mutation assay.3. ...
Trial ID:
Source:
Title:
A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors
Excerpt:
...Must have BRAF positive melanoma with the V600E mutation....
Trial ID:
Source:
Title:
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
Excerpt:
...- Must have histologically confirmed cutaneous metastatic melanoma (Stage IV) that is BRAF mutation-positive (V600 E/K) as determined via central testing with a BRAF mutation assay....
Trial ID:
Less C2 evidence
Source:
Title:
1118P - Retrospective analysis of safety in elderly BRAF V600 mutation-positive advanced melanoma patients treated with dabrafenib (D) and trametinib (T) and correlation with non-elderly patients
Published date:
09/14/2020
Excerpt:
We performed a retrospective descriptive analysis of elderly (≥75 years old, y.o.) and non-elderly (<75y.o.) BRAFV600+ advanced melanoma patients treated with D+T or D monotherapy in 10 Spanish academic centers...159 patients were included, 130 <75y.o. and 29 ≥75y.o. Clinical features were similar between groups, except in number of comorbidities, number of metastatic sites, ECOG-PS, and BRAFV600 mutation type. 5 patients per group received D monotherapy (p=0.019) and this decision was only influenced by age...D+T is safe and effective in ≥75 y.o. patients with advanced BRAF600+ melanoma.
Source:
Title:
RAF Inhibitor Dabrafenib (GSK2118436) is Active in Melanoma Brain Metastases, Multiple BRAF Genotypes and Diverse Cancers
Excerpt:
At the RP2D in patients with V600 BRAF-mutant melanoma, a response rate of 69% (a confirmed response rate of 50%) was observed overall and a 78% response rate (a confirmed response rate of 56%) in V600E BRAF-mutant melanoma.
DOI:
10.1016/S0140-6736(12)60398-5
Trial ID:
