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
14 mai 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 | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi - 13385 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206) - 35042 - Rennes - Ille-et-Vilaine - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc ( Site 1210) - 21079 - Dijon - Cote-d Or - France | Contact (sur clinicalTrials) | ||||
| centre hospitalier lyon sud-Service de dermatologie ( Site 1202) - 69310 - Pierre-Bénite - Rhone - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211) - 06200 - Nice cedex 3 - Alpes-Maritimes - France | Contact (sur clinicalTrials) | ||||
| CHU Besançon ( Site 1209) - 25030 - Besançon - Doubs - France | Contact (sur clinicalTrials) | ||||
| CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208) - 80054 - Amiens - Somme - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204) - 33075 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Hopital Claude Huriez - CHU de Lille ( Site 1207) - 59037 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis ( Site 1200) - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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)
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)
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