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# Keytruda Melanoma Combination Trial Met Endpoints
- URL: https://www.fdaweb.com/keytruda-melanoma-combination-trial-met-endpoints/
- Published: 2026-08-19T12:00:00.000Z
- Updated: 2026-09-14T12:06:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161648

Merck and Moderna say the Phase 3 INTerpath-001 trial of Keytruda (pembrolizumab) plus intismeran autogene (intismeran; V940 or mRNA-4157) met the endpoints of recurrence-free survival and distant metastasis-free survival in patients with completely resected stage IIB-IV melanoma. A Merck [statement](https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/?ref=fdaweb.com) says the results are the first positive Phase 3 readout for an individualized neoantigen therapy and for an mRNA-based cancer therapy, as well as the first Phase 3 study to demonstrate a clinically meaningful improvement over Keytruda alone, a standard-of-care immunotherapy, in the adjuvant setting for patients with resected melanoma.