A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT05933577
This study evaluates the safety and efficacy of V940, an individualized neoantigen therapy, combined with pembrolizumab in preventing melanoma recurrence. Eligible participants have resected Stage IIB-IV melanoma, are disease-free post-surgery, and have not received prior systemic therapy. Interventions include V940 (IM), pembrolizumab (IV), and a placebo (IM).
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to learn if V940 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 V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
Eligibility 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group ( Site 1943) | 72762 | Springdale | Arkansas |
| UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918) | 90095 | Los Angeles | California |
| UCSF Medical Center at Mission Bay ( Site 1929) | 94158 | San Francisco | California |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 1933) | 06510 | New Haven | Connecticut |
| Orlando Health Cancer Institute ( Site 1937) | 32806 | Orlando | Florida |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945) | 33612 | Tampa | Florida |
| Winship Cancer Institute of Emory University ( Site 1940) | 30322 | Atlanta | Georgia |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950) | 30060 | Marietta | Georgia |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 1935) | 52242 | Iowa City | Iowa |
| Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912) | 21287 | Baltimore | Maryland |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.