Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
juillet 2023
septembre 2030
02 octobre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 25/04/2024 13:32:38 | Contacter | ||
Critères
Tous
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