🏛️ Verified NIH Record • Updated 2025-09-22
A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) (NCT05933577)
A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Highlands Oncology Group ( Site 1943) — Springdale, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (165 Sites)
Showing the first 25 of 165 sites.
- Highlands Oncology Group ( Site 1943) — Springdale, Arkansas
- UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) — Los Angeles, California
- UCSF Medical Center at Mission Bay ( Site 1929) — San Francisco, California
- Yale-New Haven Hospital-Yale Cancer Center ( Site 1933) — New Haven, Connecticut
- Orlando Health Cancer Institute ( Site 1937) — Orlando, Florida
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) — Tampa, Florida
- Winship Cancer Institute of Emory University ( Site 1940) — Atlanta, Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) — Marietta, Georgia
- University of Iowa-Holden Comprehensive Cancer Center ( Site 1935) — Iowa City, Iowa
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912) — Baltimore, Maryland
- Massachusetts General Hospital ( Site 1927) — Boston, Massachusetts
- Beth Israel Deaconess Medical Center ( Site 1957) — Boston, Massachusetts
- Dana-Farber Cancer Institute ( Site 1956) — Boston, Massachusetts
- University of Michigan ( Site 1915) — Ann Arbor, Michigan
- Cancer and Hematology Centers of Western Michigan ( Site 1932) — Grand Rapids, Michigan
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944) — Hackensack, New Jersey
- Atlantic Health System ( Site 1925) — Morristown, New Jersey
- Valley Health Systems - Ridgewood Campus ( Site 1947) — Ridgewood, New Jersey
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958) — Mineola, New York
- NYU Langone Health-Perlmutter Cancer Center ( Site 1917) — New York, New York
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 1908) — New York, New York
- Memorial Sloan Kettering Cancer Center ( Site 1914) — New York, New York
- University of North Carolina Medical Center-Lineberger Comprehensive Cancer Center ( Site 1949) — Chapel Hill, North Carolina
- Duke Cancer Institute ( Site 1911) — Durham, North Carolina
- Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905) — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma
- Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
- An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) — Tucson, Arizona
- Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. — CABA, Buenos Aires
- Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients — Santa Monica, California
- NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma — Boston, Massachusetts
- A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma — Orlando, Florida
Explore by condition: All Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.