In the single-arm, open-label C-144-01 trial, a one-time infusion of a patient's own expanded tumor-infiltrating lymphocytes (lifileucel) produced an objective response in 31.5% of patients with advanced melanoma who had…
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…
In the single-arm, open-label C-144-01 trial, a one-time infusion of a patient's own expanded tumor-infiltrating lymphocytes (lifileucel) produced an objective response in 31.5% of patients with advanced melanoma who had…
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…
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Last reviewed
Clinical Trials
Important: Eligibility and enrollment are not guaranteed, and listing here is not a treatment recommendation. Talk to your care team.
Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study (The Lancet). DOI 10.1016/S0140-6736(23)02268-7.
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.
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.
Efficacy and safety of lifileucel, a one-time autologous TIL cell therapy, in patients with advanced melanoma: pooled analysis of consecutive cohorts of the C-144-01 study (Journal for ImmunoTherapy of Cancer). DOI 10.1136/jitc-2022-005755, PMID 36600653.
CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.