Status:
RECRUITING
A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Researchers want to learn if V940 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 5 2031
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06961006
Start Date
May 29 2025
End Date
September 5 2031
Last Update
December 5 2025
Active Locations (35)
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1
Highlands Oncology Group ( Site 4042)
Springdale, Arkansas, United States, 72762
2
UCSF Medical Center at Mission Bay ( Site 4044)
San Francisco, California, United States, 94158
3
John Theurer Cancer Center at Hackensack University Medical Center ( Site 4047)
Hackensack, New Jersey, United States, 07601
4
Inova Schar Cancer Institute ( Site 4046)
Fairfax, Virginia, United States, 22031