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.
Principal investigator
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
* 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
For Referring Providers
Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.