Melanoma / Skin Cancer

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

Personalized mRNA cancer vaccine plus pembrolizumab reduces melanoma recurrence risk in randomized phase 2b trial

Evidence stage: Emerging ClinicalRegulatory status: Investigational
Cancer type
Melanoma / Skin Cancer
Published
August 13, 2026

In the randomized, phase 2b KEYNOTE-942 trial, adding a personalized mRNA cancer vaccine (manufactured for each patient's own tumor mutations) to pembrolizumab reduced the risk of melanoma recurrence or death…

Primary source cited

Last reviewed

Major Advances

Personalized mRNA cancer vaccine plus pembrolizumab reduces melanoma recurrence risk in randomized phase 2b trial

Evidence stage: Emerging ClinicalRegulatory status: Investigational
Cancer type
Melanoma / Skin Cancer
Published
August 13, 2026

In the randomized, phase 2b KEYNOTE-942 trial, adding a personalized mRNA cancer vaccine (manufactured for each patient's own tumor mutations) to pembrolizumab reduced the risk of melanoma recurrence or death…

Primary source cited

Last reviewed

Clinical Trials

Important: Eligibility and enrollment are not guaranteed, and listing here is not a treatment recommendation. Talk to your care team.

Personalized mRNA cancer vaccine plus pembrolizumab reduces melanoma recurrence risk in randomized phase 2b trial

Regulatory status: InvestigationalEvidence stage: Emerging Clinical
Cancer type
Melanoma / Skin Cancer
Trial identifier
10.1016/S0140-6736(23)02268-7
View trial details
Study design
Randomized controlled trial
Population
Adults with resected, high-risk (stage IIIB-IV) melanoma, randomized 2:1 to individualized neoantigen therapy mRNA-4157/V940 plus pembrolizumab (107 patients) or pembrolizumab alone (50 patients), in the randomized, open-label, phase 2b KEYNOTE-942 trial.
Last reviewed
2026-08-13

Regulatory status by jurisdiction

Unspecified jurisdiction

Status
Investigational
Last verified
2026-08-13

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Primary evidence supporting this story

Eligibility varies — review trial criteria.

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

FDA approves lifileucel, the first tumor-derived T-cell therapy, for advanced melanoma

Regulatory status: FDA ApprovedEvidence stage: Later-Stage Human
Cancer type
Melanoma / Skin Cancer
Population
Adults with unresectable or metastatic melanoma previously treated with a PD-1-blocking antibody and, if BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor, given a one-time infusion of lifileucel. The FDA's accelerated approval rested specifically on the 73-patient efficacy-evaluable subset of cohort 4 in the single-arm, open-label, multicohort C-144-01 trial; a separately published pooled analysis combining cohorts 2 and 4 (153 patients total) reported a consistent objective response rate.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with unresectable or metastatic melanoma previously treated with a PD-1-blocking antibody and, if BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor.
Decision date
2024-02-16
Access notes
Requires specialized, REMS-certified treatment centers due to the manufacturing and lymphodepleting-chemotherapy process involved.

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

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Related resources

Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.