RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06961006

Registry updated: 2026-09-28

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Intismeran autogene (Biological)
IM injection
Pembrolizumab (Biological)
IV infusion
Placebo (Other)
IM injection

Eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has unresectable and histologically confirmed Stage III or IV cutaneous melanoma per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines. * Has been untreated for melanoma except if participant received prior adjuvant or neoadjuvant therapy with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein \[CTLA-4\], anti-programmed cell death 1 protein \[PD-1\] therapy or interferon), and only if relapse did not occur within 12 months after treatment discontinuation. * Have documentation of serine/threonine-protein kinase B-raf (BRAF) V600-activating mutation status or had BRAF V600 mutation testing per local institutional standards during the screening period (participants with BRAF mutation positive melanoma as well as BRAF wild-type or unknown are eligible). * Have the presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment. * Provides tumor tissue (preferably from a metastatic site and, if not available, from the primary tumor) that is suitable for next generation sequencing and biomarker analysis as required for this study. * Participants with human immunodeficiency virus (HIV) must have well controlled HIV on antiretroviral therapy (ART). * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has clinically significant heart failure, defined as New York Heart Association class III or IV, within the past 6 months, unless the disease is well controlled in the opinion of the investigator. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has ocular or mucosal melanoma. * Received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the Screening blood sample (including the blood sample for V940 generation). * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, lymphocyte activation gene 3 \[LAG-3\], tumor necrosis factor receptors \[OX-40 or CD137\]), with some exceptions. * Received prior systemic anticancer therapy for melanoma before randomization, with some exceptions. * Received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation related toxicities. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Received prior treatment with another universal or personalized cancer vaccine.

Conditions

Malignant Melanoma

Locations

Highlands Oncology Group ( Site 4042) — Springdale, Arkansas, United States
UCSF Medical Center at Mission Bay ( Site 4044) — San Francisco, California, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047) — Hackensack, New Jersey, United States
Inova Schar Cancer Institute ( Site 4046) — Fairfax, Virginia, United States
Fred Hutchinson Cancer Center ( Site 4041) — Seattle, Washington, United States
Blacktown Hospital ( Site 2001) — Blacktown, New South Wales, Australia
Melanoma Institute Australia ( Site 2000) — Wollstonecraft, New South Wales, Australia
One Clinical Research ( Site 2002) — Nedlands, Western Australia, Australia
William Osler Health System (Brampton Civic Hospital) ( Site 2023) — Brampton, Ontario, Canada
Sunnybrook Research Institute ( Site 2022) — Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2042) — Nice, Alpes-Maritimes, France
Hôpital Saint-Louis ( Site 2041) — Paris, Île-de-France Region, France
Gustave Roussy ( Site 2040) — Villejuif, Île-de-France Region, France
NCT ( Site 2065) — Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Frankfurt Goethe-Universität ( Site 2063) — Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Koeln ( Site 2064) — Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen ( Site 2061) — Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 2060) — Hamburg, Germany
General Hospital of Athens "Laiko" ( Site 2080) — Athens, Attica, Greece
Metropolitan Hospital ( Site 2082) — Athens, Attica, Greece
European Interbalkan Medical Center ( Site 2081) — Thessaloniki, Greece
HaEmek Medical Center ( Site 3003) — Afula, Israel
Hadassah Medical Center ( Site 3001) — Jerusalem, Israel
Rabin Medical Center ( Site 3002) — Petah Tikva, Israel
Sheba Medical Center ( Site 3000) — Ramat Gan, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 3021) — Milan, Milano, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3020) — Naples, Italy
Istituto Oncologico Veneto IRCCS ( Site 3022) — Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 3023) — Roma, Italy
Harbour Cancer & Wellness ( Site 3040) — Auckland, New Zealand
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3061) — Poznan, Greater Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3060) — Warsaw, Masovian Voivodeship, Poland
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4002) — Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 4001) — Lisbon, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 4000) — Porto, Portugal
Hospital Universitari Vall d Hebron ( Site 3081) — Barcelona, Spain
Hospital Clínic Barcelona ( Site 3080) — Barcelona, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 3082) — Madrid, Spain

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment