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New mRNA vaccine combo aims to halt advanced melanoma

NCT ID NCT06961006

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether adding a personalized mRNA vaccine (V940) to standard immunotherapy (pembrolizumab) can stop advanced melanoma from growing or spreading. About 160 people with stage III or IV melanoma that cannot be removed by surgery will receive either the vaccine plus pembrolizumab or a placebo plus pembrolizumab. The goal is to see if the combination helps people live longer without their cancer getting worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 cutaneous melanoma melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    38 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Blacktown Hospital ( Site 2001)

    RECRUITING

    Blacktown, New South Wales, 2148, Australia

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

    RECRUITING

    Nice, Alpes-Maritimes, 06202, France

  • European Interbalkan Medical Center ( Site 2081)

    RECRUITING

    Thessaloniki, 570 01, Greece

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

    RECRUITING

    Milan, Milano, 20133, Italy

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

    RECRUITING

    Roma, 00168, Italy

  • Fred Hutchinson Cancer Center ( Site 4041)

    RECRUITING

    Seattle, Washington, 98109, United States

  • General Hospital of Athens "Laiko" ( Site 2080)

    RECRUITING

    Athens, Attica, 115 27, Greece

  • Gustave Roussy ( Site 2040)

    RECRUITING

    Villejuif, Île-de-France Region, 94800, France

  • HaEmek Medical Center ( Site 3003)

    RECRUITING

    Afula, 1834111, Israel

  • Hadassah Medical Center ( Site 3001)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Harbour Cancer & Wellness ( Site 3040)

    RECRUITING

    Auckland, 1023, New Zealand

  • Highlands Oncology Group ( Site 4042)

    RECRUITING

    Springdale, Arkansas, 72762, United States

  • Hospital Clínic Barcelona ( Site 3080)

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebron ( Site 3081)

    RECRUITING

    Barcelona, 08035, Spain

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

    RECRUITING

    Madrid, 28034, Spain

  • Hôpital Saint-Louis ( Site 2041)

    RECRUITING

    Paris, Île-de-France Region, 75010, France

  • Inova Schar Cancer Institute ( Site 4046)

    RECRUITING

    Fairfax, Virginia, 22031, United States

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

    RECRUITING

    Porto, 4200-072, Portugal

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3020)

    RECRUITING

    Naples, 80131, Italy

  • Istituto Oncologico Veneto IRCCS ( Site 3022)

    RECRUITING

    Padova, 35128, Italy

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

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Melanoma Institute Australia ( Site 2000)

    RECRUITING

    Wollstonecraft, New South Wales, 2065, Australia

  • Metropolitan Hospital ( Site 2082)

    RECRUITING

    Athens, Attica, 18547, Greece

  • NCT ( Site 2065)

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

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

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • One Clinical Research ( Site 2002)

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Rabin Medical Center ( Site 3002)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Sheba Medical Center ( Site 3000)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sunnybrook Research Institute ( Site 2022)

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • UCSF Medical Center at Mission Bay ( Site 4044)

    RECRUITING

    San Francisco, California, 94158, United States

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

    RECRUITING

    Lisbon, Lisbon District, 1449-005, Portugal

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

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Universitaetsklinikum Essen ( Site 2061)

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 2060)

    RECRUITING

    Hamburg, 20251, Germany

  • Universitaetsklinikum Koeln ( Site 2064)

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Frankfurt Goethe-Universität ( Site 2063)

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3061)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 50 659, Poland

  • William Osler Health System (Brampton Civic Hospital) ( Site 2023)

    RECRUITING

    Brampton, Ontario, L6R 3J7, Canada

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