An ongoing clinical trial sponsored by Merck Sharp & Dohme is evaluating if intismeran autogene combined with pembrolizumab prevents cancer from returning in patients with high-risk melanoma. Merck and Moderna recently announced that the Phase 3 clinical trial INTerpath-001 (NCT05933577) met endpoints of recurrence-free survival and distant metastasis-free survival in patients with completely resected stage IB-IV melanoma. This makes it the first and only combination regimen to demonstrate clinically and statistically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to Keytruda alone for patients in the adjuvant melanoma setting. 

Intismeran autogene is a novel, potential first-in-class investigational mRNA-based individualized neoantigen therapy being jointly developed by Merck and Moderna. It’s produced using a patient’s tumor sample to identify the “fingerprint” (the unique mutational signature) of their cancer to generate an anti-tumor immune response. With individualized neoantigen therapies, they’re designed to train and activate anti-tumor immune responses based on that unique mutational signature of the patient’s tumor.

INTerpath-001 is the first Phase 3 trial to showcase intismeran given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to Keytruda alone.

  • A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
    • Sponsor: Merck Sharp & Dohme
    • Description: The purpose of this study is to learn if intismeran autogene which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
    • Intervention(s): Intismeran autogene, pembrolizumab, placebo
    • Primary Outcome Measure; Time Frame: Recurrence-Free Survival; Up to approximately 74 months.
    • Anticipated Primary Completion: October 2029
    • Study Details
    • Source

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