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DISEASE & TREATMENT SETTING

BRAFTOVI: unresectable metastatic Melanoma with BRAF V600E

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

• in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test.

Broader topic: Melanoma

Source population
Not part of this definition
Disease extent
metastatic
Treatment line
Not part of this definition
Stage
Not part of this definition
Resectability
unresectable
Biomarkers, prior therapy and derivation
molecular
  1. gene
    BRAF
    alteration
    V600E
    status
    present
prior therapy
    derivation status
    source-attested
    derivation note
    Scoped from the FDA approved indication for BRAFTOVI (product label). Only dimensions stated in that wording are part of this definition.
    source wording
    • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test.

    Study evidence for this setting

    8 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

    NCT01006980 · Source cited / selected · Scope: unclear

    A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)

    6 outcome links · 3 safety-group records · 0 quality-of-life measures

    →

    NCT01245062 · Source cited / selected · Scope: unclear

    GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

    6 outcome links · 3 safety-group records · 0 quality-of-life measures

    →

    NCT01584648 · Source cited / selected · Scope: unclear

    A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

    6 outcome links · 4 safety-group records · 0 quality-of-life measures

    →

    NCT01597908 · Source cited / selected · Scope: unclear

    Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

    5 outcome links · 4 safety-group records · 0 quality-of-life measures

    →

    NCT01667419 · Source cited / selected · Scope: unclear

    A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

    6 outcome links · 4 safety-group records · 1 quality-of-life measures

    →

    NCT01682083 · Source cited / selected · Scope: unclear

    Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

    6 outcome links · 4 safety-group records · 0 quality-of-life measures

    →

    NCT01909453 · Source cited / selected · Scope: unclear

    Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma

    6 outcome links · 5 safety-group records · 8 quality-of-life measures

    →

    NCT04985604 · Registry condition search · Scope: unclear

    Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors

    6 outcome links · 2 safety-group records · 0 quality-of-life measures

    →
    Source relationships and population-mapping limitations
    bindings
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice