Recruiting
Phase 2

V940 & Pembrolizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06961006

Conditions

Malignant Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intismeran autogene

Pembrolizumab

Placebo

Study Details

Brief 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.

Conditions

Malignant Melanoma

Study ID

NCT06961006

Start date

May 29, 2025

Status verified date

Jul, 2026

Completion date

Sep 5, 2031

Anticipated

Primary completion date

Jul 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intismeran autogene + Pembrolizumab

Participants 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.

active comparator: 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.

Interventions

Intismeran autogene

IM injection

Pembrolizumab

IV infusion

Placebo

IM injection

Primary outcome measure

  • Progression-free Survival (PFS) [ Time Frame: Up to approximately 36 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Highlands Oncology Group ( Site 4042)

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Study Coordinator

479-872-8130

UCSF Medical Center at Mission Bay ( Site 4044)

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Coordinator

877-827-3222

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

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-1777

Inova Schar Cancer Institute ( Site 4046)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

571-472-0237

Fred Hutchinson Cancer Center ( Site 4041)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

206-606-7341

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

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Contacts

Study Coordinator

6472054387

Sunnybrook Research Institute ( Site 2022)

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

4164804757

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-07-02.