RecruitingPhase 2NCT06961006

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

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

160 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

Malignant Melanoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine called V940 combined with pembrolizumab (an immunotherapy drug) in people with advanced melanoma (skin cancer). The vaccine is made from each person's own tumor to train the immune system to target the cancer. This is a phase 2/3 trial looking at whether this combination helps people live longer without their cancer growing. **You may be eligible if...** - You have advanced or metastatic melanoma (stage III or IV) that cannot be surgically removed - Your melanoma is cutaneous (skin-based), and you may have a BRAF mutation or not — both are eligible - You have at least one measurable tumor on imaging - You can provide a tumor sample for genetic analysis - If you have HIV, it is well controlled on treatment - Previous adjuvant (preventive) immunotherapy is allowed if relapse happened more than 12 months after stopping **You may NOT be eligible if...** - You have ocular (eye) or mucosal (mouth/nose/genitals) melanoma - You have received prior immunotherapy for advanced melanoma (with some exceptions) - You have had radiation therapy in the past 2 weeks - You received a live vaccine in the past 30 days - You have significant heart failure (NYHA class III or IV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIntismeran autogene

IM injection

BIOLOGICALPembrolizumab

IV infusion

OTHERPlacebo

IM injection

Locations(38)

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

View Full Details on ClinicalTrials.gov

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NCT06961006

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