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

Launched by MERCK SHARP & DOHME LLC · Apr 29, 2025

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ClinConnect Summary

This clinical trial is studying a new combination treatment for advanced melanoma, which is a serious form of skin cancer that has spread and cannot be removed by surgery. The researchers want to find out if using a study medication called V940 along with pembrolizumab, a standard immunotherapy drug, can help patients live longer without their cancer growing or spreading compared to those receiving a placebo (a treatment that looks like the real medication but has no active ingredients). This is important because immunotherapy helps the body’s immune system fight cancer, and V940 is designed to specifically target a person’s melanoma.

To participate in this trial, individuals must be between 65 and 74 years old and have a confirmed diagnosis of advanced melanoma that cannot be surgically removed. They should not have received treatment for their melanoma recently, and must have specific test results regarding a gene mutation known as BRAF. Participants will need to provide a tissue sample for testing and undergo regular check-ups to monitor their condition. It's important to note that this trial is not yet recruiting participants, so those interested will need to wait until it begins.

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ALL

Eligibility criteria

• 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.