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Malignant MelanomaPhase 2NCT06961006

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

A Phase 2 study testing Intismeran autogene and Pembrolizumab in people with Malignant Melanoma, run by Merck Sharp & Dohme LLC at 38 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Intismeran autogene and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
38 sitesin 12 countries
Study dates
29 May 2025to 5 Sep 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

38 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

38 sites in 12 countries

United States5 sites, 5 recruiting

  • Inova Schar Cancer Institute ( Site 4046)

    Fairfax, Virginia, 22031

    Study Coordinator, 571-472-0237

    Recruiting

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

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-1777

    Recruiting

  • UCSF Medical Center at Mission Bay ( Site 4044)

    San Francisco, California, 94158

    Study Coordinator, 877-827-3222

    Recruiting

  • Fred Hutchinson Cancer Center ( Site 4041)

    Seattle, Washington, 98109

    Study Coordinator, 206-606-7341

    Recruiting

  • Highlands Oncology Group ( Site 4042)

    Springdale, Arkansas, 72762

    Study Coordinator, 479-872-8130

    Recruiting

Other trials in United States

Germany5 sites, 5 recruiting

  • Universitaetsklinikum Koeln ( Site 2064)

    Cologne, North Rhine-Westphalia, 50937

    Study Coordinator, 00491737057524

    Recruiting

  • Universitaetsklinikum Essen ( Site 2061)

    Essen, North Rhine-Westphalia, 45147

    Study Coordinator, 00492017232431

    Recruiting

  • Universitätsklinikum Frankfurt Goethe-Universität ( Site 2063)

    Frankfurt am Main, Hesse, 60590

    Study Coordinator, +496963015311

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 2060)

    Hamburg, 20251

    Study Coordinator, 00494074100

    Recruiting

  • NCT ( Site 2065)

    Heidelberg, Baden-Wurttemberg, 69120

    Study Coordinator, +496221568562

    Recruiting

Other trials in Germany

Israel4 sites, 4 recruiting

  • HaEmek Medical Center ( Site 3003)

    Afula, 1834111

    Study Coordinator, +972-4-6494000

    Recruiting

  • Hadassah Medical Center ( Site 3001)

    Jerusalem, 9112001

    Study Coordinator, +97226777333

    Recruiting

  • Rabin Medical Center ( Site 3002)

    Petah Tikva, 4941492

    Study Coordinator, +97239377377

    Recruiting

  • Sheba Medical Center ( Site 3000)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

Other trials in Israel

Italy4 sites, 4 recruiting

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

    Milan, Milano, 20133

    Study Coordinator, 0223902557

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3020)

    Naples, 80131

    Study Coordinator, +3908117770810

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 3022)

    Padova, 35128

    Study Coordinator, 0498215609

    Recruiting

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

    Roma, 00168

    Study Coordinator, +390630155202

    Recruiting

Other trials in Italy

Australia3 sites, 3 recruiting

  • Blacktown Hospital ( Site 2001)

    Blacktown, New South Wales, 2148

    Study Coordinator, +61298818000

    Recruiting

  • One Clinical Research ( Site 2002)

    Nedlands, Western Australia, 6009

    Study Coordinator, +61 8 6279 9466

    Recruiting

  • Melanoma Institute Australia ( Site 2000)

    Wollstonecraft, New South Wales, 2065

    Study Coordinator, +61299117200

    Recruiting

Other trials in Australia

France3 sites, 3 recruiting

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

    Nice, Alpes-Maritimes, 06202

    Study Coordinator, +33492036667

    Recruiting

  • Hôpital Saint-Louis ( Site 2041)

    Paris, Île-de-France Region, 75010

    Study Coordinator, +33142499961

    Recruiting

  • Gustave Roussy ( Site 2040)

    Villejuif, Île-de-France Region, 94800

    Study Coordinator, +33142114211

    Recruiting

Other trials in France

Greece3 sites, 3 recruiting

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

    Athens, Attica, 115 27

    Study Coordinator, 0030 2132060954

    Recruiting

  • Metropolitan Hospital ( Site 2082)

    Athens, Attica, 18547

    Study Coordinator, 0030 2104809739

    Recruiting

  • European Interbalkan Medical Center ( Site 2081)

    Thessaloniki, 570 01

    Study Coordinator, 0030 2310400213

    Recruiting

Other trials in Greece

Portugal3 sites, 3 recruiting

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

    Lisbon, Lisbon District, 1449-005

    Study Coordinator, +351210431000

    Recruiting

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

    Lisbon, 1649-035

    Study Coordinator, +351210519790

    Recruiting

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

    Porto, 4200-072

    Study Coordinator, +351225084000

    Recruiting

Other trials in Portugal

Spain3 sites, 3 recruiting

  • Hospital Universitari Vall d Hebron ( Site 3081)

    Barcelona, 08035

    Study Coordinator, +34932746000

    Recruiting

  • Hospital Clínic Barcelona ( Site 3080)

    Barcelona, 08036

    Study Coordinator, +34932275402

    Recruiting

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

    Madrid, 28034

    Study Coordinator, +34913368263

    Recruiting

Other trials in Spain

Canada2 sites, 2 recruiting

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

    Brampton, Ontario, L6R 3J7

    Study Coordinator, 6472054387

    Recruiting

  • Sunnybrook Research Institute ( Site 2022)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 4164804757

    Recruiting

Other trials in Canada

Poland2 sites, 2 recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 3061)

    Poznan, Greater Poland Voivodeship, 50 659

    Study Coordinator, +48611019893

    Recruiting

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

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462540

    Recruiting

Other trials in Poland

New Zealand1 site, 1 recruiting

  • Harbour Cancer & Wellness ( Site 3040)

    Auckland, 1023

    Study Coordinator, +6492203333

    Recruiting

Other trials in New Zealand

About this study

Official title: 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)

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.

Being tested
Intismeran autogene, Pembrolizumab, Placebo
Keywords
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)
Medical subject headings
Melanoma, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intismeran autogeneBiological

    Also called mRNA-4157, V940

    IM injection

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV infusion

  • PlaceboOther

    IM injection

Study groups in NCT06961006
Study groupRoleWhat they receive
Intismeran autogene + PembrolizumabExperimentalParticipants will receive 1 mg of intismeran autogene 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.
Receives: Biological: Intismeran autogene; Biological: Pembrolizumab
Placebo + PembrolizumabActive comparatorParticipants 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.
Receives: Biological: Pembrolizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by investigator assessment or death due to any cause, whichever occurs first. Progressive disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 as assessed by investigator will be presented.

    Measured: Up to approximately 36 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR per RECIST 1.1 as assessed by investigator will be presented.

    Measured: Up to approximately 6 years

  2. Duration of Response (DOR)

    For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator will be presented.

    Measured: Up to approximately 6 years

  3. Overall Survival (OS)

    OS is defined as time from randomization to death due to any cause.

    Measured: Up to approximately 6 years

  4. Number of Participants With ≥1 Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported.

    Measured: Up to approximately 27 months

  5. Number of Participants Discontinuing From Study Therapy Due to AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start29 May 2025
  3. Primary completion22 Jul 2028 (estimated)
  4. Study completion5 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06961006
Sponsor's protocol ID
V940-012
Other IDs
V940-012, INTerpath-012, 2023-504923-20-00, U1111-1290-3969, 2023
Status last verified
Sep 2026
First submitted
29 Apr 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intismeran autogene and Pembrolizumab in people with Malignant Melanoma, run by Merck Sharp & Dohme LLC at 38 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Germany, Israel, Italy, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Up to approximately 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06961006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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