DISEASE & TREATMENT SETTING

Melanoma

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

Exact scope

Melanoma

Source population: Not part of this definition
Disease extent: Not part of this definition
Treatment line: Not part of this definition
Stage: Not part of this definition
Resectability: Not part of this definition

Biomarkers, prior therapy and derivation

molecular
prior therapy
derivation status: source-attested
derivation note: Derived from NCI topic(s): Melanoma. Strongest NCIt resolution: exact. Entity-level scope; stage, biomarker and treatment line are not yet part of this definition.
source wording: Source null

34 more-specific settings

Study evidence for this setting

Find a linked studyHow it was found

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

NCT00091572 · Source cited / selected · Scope: narrower

Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

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

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NCT00094653 · Source cited / selected · Scope: narrower

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

6 outcome links · 3 safety-group records · 1 quality-of-life measures

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NCT00441337 · Registry condition search · Scope: narrower

A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies

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

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NCT00587964 · Registry condition search · Scope: narrower

Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases

1 outcome links · 1 safety-group records · 0 quality-of-life measures

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NCT00623831 · Registry condition search · Scope: narrower

A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen

4 outcome links · 2 safety-group records · 1 quality-of-life measures

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NCT00753415 · Registry condition search · Scope: narrower

A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

3 outcome links · 10 safety-group records · 0 quality-of-life measures

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NCT00769704 · Source cited / selected · Scope: narrower

Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

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

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NCT01006980 · Source cited / selected · Scope: narrower

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

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NCT01037790 · Registry condition search · Scope: narrower

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer

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

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NCT01213472 · Registry condition search · Scope: narrower

Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma

6 outcome links · 1 safety-group records · 0 quality-of-life measures

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NCT01245062 · Source cited / selected · Scope: narrower

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

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NCT01274338 · Source cited / selected · Scope: narrower

Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery

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

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NCT01390818 · Registry condition search · Scope: narrower

Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors

6 outcome links · 15 safety-group records · 0 quality-of-life measures

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NCT01557881 · Registry condition search · Scope: narrower

Positron Emission Tomography/Magnetic Resonance Imaging in Patients

3 outcome links · 1 safety-group records · 0 quality-of-life measures

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NCT01584648 · Source cited / selected · Scope: narrower

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

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NCT01597908 · Source cited / selected · Scope: narrower

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

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NCT01667419 · Source cited / selected · Scope: narrower

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: narrower

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

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NCT01704287 · Source cited / selected · Scope: narrower

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

6 outcome links · 7 safety-group records · 0 quality-of-life measures

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NCT01721746 · Source cited / selected · Scope: narrower

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4

6 outcome links · 2 safety-group records · 1 quality-of-life measures

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Indication-specific source history

Dated source events, not confirmation of current approval for every use of a drug.

2014-01-08 · Mekinist (trametinib) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-bfacc7b857c1c66c
event date: 2014-01-08
event kind: accelerated-approval
drug or regimen: Mekinist (trametinib)
source indication text: In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-00371e8bedd8f3ef5f08
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2014-01-09 · Tafinlar (dabrafenib) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-6118aed20083e46b
event date: 2014-01-09
event kind: accelerated-approval
drug or regimen: Tafinlar (dabrafenib)
source indication text: In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-194abfede1dcff6ca398
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2014-09-04 · Keytruda (pembrolizumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-456974ed3f271215
event date: 2014-09-04
event kind: accelerated-approval
drug or regimen: Keytruda (pembrolizumab)
source indication text: Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-b829a289084cdb79957f
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2014-12-22 · Opdivo (nivolumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-e3d32a1a35aa27c8
event date: 2014-12-22
event kind: accelerated-approval
drug or regimen: Opdivo (nivolumab)
source indication text: Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-057ff655a8c7ee90a918
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2015-09-30 · Opdivo (nivolumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-7c47085520899e58
event date: 2015-09-30
event kind: accelerated-approval
drug or regimen: Opdivo (nivolumab)
source indication text: In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-1657d1070bff60a00a58
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2015-11-20 · Mekinist (trametinib) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-6b45b6d316d8502a
event date: 2015-11-20
event kind: traditional-approval
drug or regimen: Mekinist (trametinib)
source indication text: In combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-00371e8bedd8f3ef5f08
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2015-11-20 · Tafinlar (dabrafenib) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-aa0c800cddd9cc6b
event date: 2015-11-20
event kind: traditional-approval
drug or regimen: Tafinlar (dabrafenib)
source indication text: In combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-194abfede1dcff6ca398
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2015-12-18 · Keytruda (pembrolizumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-d361ebf745173e6a
event date: 2015-12-18
event kind: traditional-approval
drug or regimen: Keytruda (pembrolizumab)
source indication text: Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-b829a289084cdb79957f
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2016-01-23 · Opdivo (nivolumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-0f32eea45216f1fe
event date: 2016-01-23
event kind: accelerated-approval
drug or regimen: Opdivo (nivolumab)
source indication text: 1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-19478e760c876366fa03
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2019-03-07 · Opdivo (nivolumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-6b0015b92afd5960
event date: 2019-03-07
event kind: traditional-approval
drug or regimen: Opdivo (nivolumab)
source indication text: In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-1657d1070bff60a00a58
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2019-03-07 · Opdivo (nivolumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-be7d45aa292d57ff
event date: 2019-03-07
event kind: traditional-approval
drug or regimen: Opdivo (nivolumab)
source indication text: Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-057ff655a8c7ee90a918
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2019-03-07 · Opdivo (nivolumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-f504b6cf0e59df41
event date: 2019-03-07
event kind: traditional-approval
drug or regimen: Opdivo (nivolumab)
source indication text: 1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor
match phrase: melanoma
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-19478e760c876366fa03
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2024-02-16 · Amtagvi (lifileucel) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-b572f2c9bdab2b05
event date: 2024-02-16
event kind: accelerated-approval
drug or regimen: Amtagvi (lifileucel)
source indication text: Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
match phrase: melanoma
match status: candidate
status category: ongoing
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-b7401160be177b705904
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2026-08-06 · Tudriqev (vusolimogene oderparepvec-wtpg) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: fda-94ff455c7e61347b
event date: 2026-08-06
event kind: accelerated-approval
drug or regimen: Tudriqev (vusolimogene oderparepvec-wtpg)
source indication text: In combination with nivolumab for treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen
match phrase: melanoma
match status: candidate
status category: ongoing
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-2fe2c9fa98788955f5f6
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2026-08-06 · vusolimogene oderparepvec-wtpg in combination with nivolumab · approval notification

release id: clinical-indications-draft-1
disease state id: ds-melanoma
event id: notice-347413b3c5e3abc9
event date: 2026-08-06
event kind: approval-notification
drug or regimen: vusolimogene oderparepvec-wtpg in combination with nivolumab
source indication text: FDA approved vusolimogene oderparepvec-wtpg, a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 -blocking antibody-based regimen.
match phrase: melanoma
match status: candidate
status category: accelerated
has date discrepancy: 0
source collection: fda-approval-notice
source key: fda-f02afa7b64e90adf
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

Source relationships and population-mapping limitations

bindings

release id
clinical-indications-draft-1
disease state id
ds-melanoma
binding id
ncit-C3224
source collection
ncit-concept
source key
C3224
source excerpt
Source null
match status
exact
match note
Source null
recorded at
2026-09-10T00:00:00Z

mappings

Download this complete draft source relationship record →

Preserved source evidence · Not medical advice