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DISEASE & TREATMENT SETTING

Opdivo: unresectable metastatic Melanoma with BRAF V600, BRAF stated without a specific alteration after prior therapy

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

Exact scope

Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor

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
    V600
    status
    present
  2. gene
    BRAF
    alteration
    stated without a specific alteration
    status
    present
prior therapy
  1. class
    following ipilimumab and
    status
    required
derivation status
source-attested
derivation note
Scoped from the FDA approved indication for Opdivo (nivolumab) (accelerated-approval table). Only dimensions stated in that wording are part of this definition.
source wording
Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor

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

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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

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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