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Clinical Study of Intismeran Autogene and Pembrolizumab for Melanoma

This study is testing if a combination of Intismeran autogene and Pembrolizumab (an immunotherapy that helps your immune system fight cancer) can stop advanced melanoma (a type of skin cancer that has spread and can't be surgically removed) from growing or spreading. Researchers want to see if people receiving Intismeran autogene with Pembrolizumab live longer without their cancer progressing compared to those receiving a placebo (an inactive substance) with Pembrolizumab. You could be eligible if you have unresectable Stage III or IV cutaneous melanoma and are at least 18 years old. The study aims to enroll 160 participants.

Study design
This interventional study plans to enroll 160 participants. It compares Intismeran autogene plus Pembrolizumab to a placebo plus Pembrolizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival (how long they live without the cancer growing or spreading) for up to approximately 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06961006

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~160 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Intismeran autogenePembrolizumabPlacebo

At a glance

Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS)
Measured over Up to approximately 36 months

Conditions

Malignant Melanoma

Explore related trials

Cutaneous Melanoma

Where it's being run

38 sites across 25 states
Israel4
Italy3
Spain3
New South Wales2
Ontario2
Île-de-France Region2
North Rhine-Westphalia2
Attica2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-free Survival (PFS)Up to approximately 36 months

    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.