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)
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)
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:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Los Angeles, California 90095, United States
Tampa, Florida 33612, United States
Marietta, Georgia 30060, United States
Iowa City, Iowa 52242, United States
Baltimore, Maryland 21287, United States
Grand Rapids, Michigan 49503, United States
Hackensack, New Jersey 07601, United States
Mineola, New York 11501, United States
New York, New York 10032, United States
Chapel Hill, North Carolina 27599, United States
Philadelphia, Pennsylvania 19104, United States
Charleston, South Carolina 29425, United States
Caba., Buenos Aires C1430EGF, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
Buenos Aires, Buenos Aires F.D. 1426ANZ, Argentina
Río Cuarto, Córdoba Province X5800ALB, Argentina
Wollstonecraft, New South Wales 2065, Australia
Melbourne, Victoria 3000, Australia
Belo Horizonte, Minas Gerais 30130-090, Brazil
Ijuí, Rio Grande do Sul 98700-000, Brazil
Rio de Janeiro, 20220-410, Brazil
Toronto, Ontario M5G 2M9, Canada
Montreal, Quebec H2X 0X9, Canada
Québec, Quebec G1J 1Z4, Canada
Santiago, Region M. de Santiago 7620002, Chile
Bogotá, Bogota D.C. 111321, Colombia
Nice, Alpes-Maritimes 06200, France
Marseille, Bouches-du-Rhone 13385, France
Rennes, Ille-et-Vilaine 35042, France
München, Bavaria 80337, Germany
Göttingen, Lower Saxony 37075, Germany
Rostock, Mecklenburg-Vorpommern 18057, Germany
Essen, North Rhine-Westphalia 45147, Germany
Minden, North Rhine-Westphalia 32429, Germany
Berlin, 10115, Germany
Athens, Attica 115 26, Greece
Thessaloniki, Central Macedonia 546 22, Greece
Siena, Tuscany 53100, Italy
Naples, 80131, Italy
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan
Newtown, Wellington Region 6021, New Zealand
Poznan, Greater Poland Voivodeship 60-569, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Siedlce, Masovian Voivodeship 08-110, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Gdansk, Pomeranian Voivodeship 80-214, Poland
Gliwice, Silesian Voivodeship 44-101, Poland
Szczecin, West Pomeranian Voivodeship 71-730, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Lisbon, Lisbon District 1099-023, Portugal
Lisbon, 1449-005, Portugal
Lisbon, 1649-035, Portugal
Porto, 4200-072, Portugal
Daegu, Taegu-Kwangyokshi 41404, South Korea
Daejeon, Taejon-Kwangyokshi 35015, South Korea
Seoul, 03722, South Korea
Barcelona, Catalonia 08036, Spain
Barcelona, 08035, Spain
Zürich Flughafen, Canton of Zurich 8058, Switzerland
Istanbul, 34303, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Bristol, Bristol, City of BS2 8ED, United Kingdom
Cringleford, England NR4 7UY, United Kingdom