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A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Trial Status: closed to accrual
The purpose of this study is to learn if intismeran autogene which is an individualized
neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with
pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with
high-risk melanoma. Researchers want to know if intismeran autogene with pembrolizumab is
better than receiving pembrolizumab alone at preventing the cancer from returning.
Inclusion Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has surgically resected and histologically/pathologically confirmed diagnosis of
Stage IIB or IIC, III, or IV cutaneous melanoma
- Has not received any prior systemic therapy for their melanoma beyond surgical
resection
- No more than 13 weeks have passed between final surgical resection that rendered the
participant disease-free and the first dose of pembrolizumab
- Is disease free at the time of providing documented consent for the study
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on anti-retroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has ocular or mucosal melanoma
- Has cancer that has spread to other parts of the body and cannot be removed with
surgery
- Has heart failure within the past 6 months
- Has received prior cancer therapy or another cancer vaccine
- Has another known cancer that that has spread to other parts of the body or has
required treatment within the past 3 years
- Has severe reaction to study medications or any of their substance used to prepare a
drug
- Have not recovered from major surgery or have ongoing surgical complications
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05933577.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Temporarily closed to accrual
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Massachusetts General Hospital Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not Available
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center