🏛️ Verified NIH Record • Updated 2026-07-01

A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012) (NCT06961006)

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

Researchers want to learn if intismeran autogene with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Intismeran autogene is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.

Who can join: Review the eligibility criteria below.

Location: Highlands Oncology Group ( Site 4042) — Springdale, Arkansas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • Highlands Oncology Group ( Site 4042) — Springdale, Arkansas
  • UCSF Medical Center at Mission Bay ( Site 4044) — San Francisco, California
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047) — Hackensack, New Jersey
  • Inova Schar Cancer Institute ( Site 4046) — Fairfax, Virginia
  • Fred Hutchinson Cancer Center ( Site 4041) — Seattle, Washington
  • Blacktown Hospital ( Site 2001) — Blacktown, New South Wales
  • Melanoma Institute Australia ( Site 2000) — Wollstonecraft, New South Wales
  • One Clinical Research ( Site 2002) — Nedlands, Western Australia
  • William Osler Health System (Brampton Civic Hospital) ( Site 2023) — Brampton, Ontario
  • Sunnybrook Research Institute ( Site 2022) — Toronto, Ontario
  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2042) — Nice, Alpes-Maritimes
  • Hôpital Saint-Louis ( Site 2041) — Paris, Île-de-France Region
  • Gustave Roussy ( Site 2040) — Villejuif, Île-de-France Region
  • NCT ( Site 2065) — Heidelberg, Baden-Wurttemberg
  • Universitätsklinikum Frankfurt Goethe-Universität ( Site 2063) — Frankfurt am Main, Hesse
  • Universitaetsklinikum Koeln ( Site 2064) — Cologne, North Rhine-Westphalia
  • Universitaetsklinikum Essen ( Site 2061) — Essen, North Rhine-Westphalia
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 2060) — Hamburg,
  • General Hospital of Athens "Laiko" ( Site 2080) — Athens, Attica
  • Metropolitan Hospital ( Site 2082) — Athens, Attica
  • European Interbalkan Medical Center ( Site 2081) — Thessaloniki,
  • HaEmek Medical Center ( Site 3003) — Afula,
  • Hadassah Medical Center ( Site 3001) — Jerusalem,
  • Rabin Medical Center ( Site 3002) — Petah Tikva,
  • Sheba Medical Center ( Site 3000) — Ramat Gan,

📞 Contact the Study Coordinator

Phone: (888) 577-8839

Email: Trialsites@msd.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 Malignant Melanoma

Explore by condition: All Malignant Melanoma clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗