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

NCT ID: NCT06961006

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2031-09-05

Brief Summary

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Researchers want to learn if V940 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. V940 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 V940 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.

Detailed Description

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Conditions

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Malignant Melanoma

Keywords

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Programmed Cell Death-1 (PD1, PD-1) Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1) Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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V940 + Pembrolizumab

Participants will receive 1 mg of V940 via intramuscular (IM) injection every 3 weeks (q3w) for up to 9 doses (up to approximately 27 weeks) plus 400 mg of pembrolizumab via intravenous (IV) infusion every 6 weeks (q6w) for up to 17 doses, or for a total treatment duration of up to approximately 2 years, or until disease progression or discontinuation.

Group Type EXPERIMENTAL

V940

Intervention Type BIOLOGICAL

IM injection

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Placebo + Pembrolizumab

Participants will receive placebo via IM injection q3w for up to 9 doses (up to approximately 27 weeks) plus 400 mg of pembrolizumab via IV infusion q6w for up to 17 doses, or for a total treatment duration of up to approximately 2 years, or until disease progression or discontinuation.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Placebo

Intervention Type OTHER

IM injection

Interventions

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V940

IM injection

Intervention Type BIOLOGICAL

Pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

Placebo

IM injection

Intervention Type OTHER

Other Intervention Names

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mRNA-4157 MK-3475 KEYTRUDA®

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Highlands Oncology Group ( Site 4042)

Springdale, Arkansas, United States

Site Status RECRUITING

UCSF Medical Center at Mission Bay ( Site 4044)

San Francisco, California, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047)

Hackensack, New Jersey, United States

Site Status RECRUITING

Inova Schar Cancer Institute ( Site 4046)

Fairfax, Virginia, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center ( Site 4041)

Seattle, Washington, United States

Site Status RECRUITING

Blacktown Hospital ( Site 2001)

Blacktown, New South Wales, Australia

Site Status RECRUITING

Melanoma Institute Australia ( Site 2000)

Wollstonecraft, New South Wales, Australia

Site Status RECRUITING

One Clinical Research ( Site 2002)

Nedlands, Western Australia, Australia

Site Status RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 2042)

Nice, Alpes-Maritimes, France

Site Status RECRUITING

Hôpital Saint-Louis ( Site 2041)

Paris, Île-de-France Region, France

Site Status RECRUITING

Gustave Roussy ( Site 2040)

Villejuif, Île-de-France Region, France

Site Status RECRUITING

NCT ( Site 2065)

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Universitaetsklinikum Koeln ( Site 2064)

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitaetsklinikum Hamburg-Eppendorf ( Site 2060)

Hamburg, , Germany

Site Status RECRUITING

General Hospital of Athens "Laiko" ( Site 2080)

Athens, Attica, Greece

Site Status RECRUITING

Metropolitan Hospital ( Site 2082)

Athens, Attica, Greece

Site Status RECRUITING

European Interbalkan Medical Center ( Site 2081)

Thessaloniki, , Greece

Site Status RECRUITING

Emek Medical Center ( Site 3003)

Afula, , Israel

Site Status RECRUITING

Hadassah Medical Center ( Site 3001)

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 3002)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 3000)

Ramat Gan, , Israel

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 3021)

Milan, Milano, Italy

Site Status RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3020)

Napoli, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 3023)

Roma, , Italy

Site Status RECRUITING

Harbour Cancer & Wellness ( Site 3040)

Auckland, , New Zealand

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 3060)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4002)

Lisbon, Lisbon District, Portugal

Site Status RECRUITING

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 4001)

Lisbon, , Portugal

Site Status RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 4000)

Porto, , Portugal

Site Status RECRUITING

Hospital Universitari Vall d'Hebron ( Site 3081)

Barcelona, , Spain

Site Status RECRUITING

Hospital Clínic Barcelona ( Site 3080)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 3082)

Madrid, , Spain

Site Status RECRUITING

Countries

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United States Australia France Germany Greece Israel Italy New Zealand Poland Portugal Spain

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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V940-012

Identifier Type: OTHER

Identifier Source: secondary_id

INTerpath-012

Identifier Type: OTHER

Identifier Source: secondary_id

2023-504923-20-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1290-3969

Identifier Type: REGISTRY

Identifier Source: secondary_id

V940-012

Identifier Type: -

Identifier Source: org_study_id