Spots Global Cancer Trial Database for A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
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Trial Identification
Brief Title: A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Official Title: 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)
Study ID: NCT05933577
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group ( Site 1943), Springdale, Arkansas, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918), Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 1929), San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1933), New Haven, Connecticut, United States
Orlando Health Cancer Institute ( Site 1937), Orlando, Florida, United States
Winship Cancer Institute of Emory University ( Site 1940), Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950), Marietta, Georgia, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1935), Iowa City, Iowa, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912), Baltimore, Maryland, United States
Cancer and Hematology Centers of Western Michigan ( Site 1932), Grand Rapids, Michigan, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1944), Hackensack, New Jersey, United States
Atlantic Health System ( Site 1925), Morristown, New Jersey, United States
Valley Health Systems - Ridgewood Campus ( Site 1947), Ridgewood, New Jersey, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1958), Mineola, New York, United States
NYU Langone Health-Perlmutter Cancer Center ( Site 1917), New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1914), New York, New York, United States
Duke Cancer Institute ( Site 1911), Durham, North Carolina, United States
Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 1905), Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center ( Site 1909), Pittsburgh, Pennsylvania, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 1934), Charleston, South Carolina, United States
Sanford Cancer Center ( Site 1951), Sioux Falls, South Dakota, United States
Texas Oncology - Austin ( Site 1903), Austin, Texas, United States
Texas Oncology - Dallas (Sammons) ( Site 1902), Dallas, Texas, United States
University of Texas MD Anderson Cancer Center ( Site 1920), Houston, Texas, United States
Inova Schar Cancer Institute ( Site 1900), Fairfax, Virginia, United States
Fred Hutchinson Cancer Center ( Site 1901), Seattle, Washington, United States
Hospital Aleman ( Site 2200), Buenos Aires, Caba, Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 2201), Río Cuarto, Cordoba, Argentina
Sanatorio Finochietto ( Site 2205), Buenos Aires, , Argentina
Clinica Adventista Belgrano-Oncology ( Site 2204), Caba, , Argentina
Westmead Hospital-Department of Medical Oncology ( Site 1001), Westmead, New South Wales, Australia
Melanoma Institute Australia-Clinical Trials Unit ( Site 1000), Wollstonecraft, New South Wales, Australia
Princess Alexandra Hospital ( Site 1003), Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005), Melbourne, Victoria, Australia
The Alfred Hospital-Medical Oncology Alfred Cancer Trials ( Site 1004), Melbourne, Victoria, Australia
One Clinical Research ( Site 1002), Nedlands, Western Australia, Australia
UZ Brussel-Medische oncologie ( Site 3405), Brussels, Bruxelles-Capitale, Region De, Belgium
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3402), Genk, Limburg, Belgium
UZ Gent ( Site 3403), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 3400), Leuven, Vlaams-Brabant, Belgium
AZ Groeninge Campus Kennedylaan-Oncology ( Site 3401), Kortrijk, West-Vlaanderen, Belgium
Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 2303), Belo Horizonte, Minas Gerais, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 2302), Ijui, Rio Grande Do Sul, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300), São Paulo, Sao Paulo, Brazil
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC II ( Site 2305), Rio de Janeiro, , Brazil
BC Cancer Vancouver-Clinical Trials Unit ( Site 1106), Vancouver, British Columbia, Canada
William Osler Health System ( Site 1105), Brampton, Ontario, Canada
Sunnybrook Research Institute ( Site 1103), Toronto, Ontario, Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1102), Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo, Montréal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101), Quebec City, Quebec, Canada
FALP-UIDO ( Site 2400), Santiago, Region M. De Santiago, Chile
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 2401), Santiago, Region M. De Santiago, Chile
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2506), Rionegro, Antioquia, Colombia
Oncomédica S.A.S-Oncomedica S.A ( Site 2503), Montería, Cordoba, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2500), Bogota, Distrito Capital De Bogota, Colombia
Fundación Valle del Lili ( Site 2505), Cali, Valle Del Cauca, Colombia
Herlev and Gentofte Hospital ( Site 3301), Copenhagen, Hovedstaden, Denmark
Aalborg Universitetshospital, Syd ( Site 3302), Aalborg, Nordjylland, Denmark
Odense Universitetshospital ( Site 3300), Odense, Syddanmark, Denmark
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Dermatology Department ( Site 1211), Nice cedex 3, Alpes-Maritimes, France
Centre Georges François Leclerc ( Site 1210), Dijon, Cote-d Or, France
CHU Besançon ( Site 1209), Besançon, Doubs, France
CHU de Bordeaux Hop St ANDRE-Service de Dermatologie ( Site 1204), Bordeaux, Gironde, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1206), Rennes, Ille-et-Vilaine, France
Hopital Claude Huriez - CHU de Lille ( Site 1207), Lille, Nord, France
centre hospitalier lyon sud-Service de dermatologie ( Site 1202), Pierre-Bénite, Rhone, France
CHU d'Amiens-Picardie - Hôpital Sud-Dermatologie ( Site 1208), Amiens, Somme, France
Gustave Roussy-Dermatologie ( Site 1201), Villejuif, Val-de-Marne, France
Hôpital Saint-Louis ( Site 1200), Paris, , France
Universitätsmedizin Mannheim ( Site 1305), Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Augsburg ( Site 1312), Augsburg, Bayern, Germany
Klinik und Poliklinik für Dermatologie und Allergologie-Dermato-oncology ( Site 1315), München, Bayern, Germany
Universitätsmedizin Rostock-Klinik und Poliklinik für Dermatologie und Venerologie ( Site 1310), Rostock, Mecklenburg-Vorpommern, Germany
Universitätsmedizin Göttingen - Georg-August-Universität-Dermatology ( Site 1308), Göttingen, Niedersachsen, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 1300), Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Koeln ( Site 1307), Köln, Nordrhein-Westfalen, Germany
Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 1301), Minden, Nordrhein-Westfalen, Germany
Universitaetsklinikum des Saarlandes ( Site 1313), Homburg, Saarland, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1306), Gera, Thuringen, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 1302), Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1309), Hamburg, , Germany
General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 3700), Athens, Attiki, Greece
Metropolitan Hospital-A' Oncology Dpt ( Site 3701), Neo Faliro, Attiki, Greece
Bioclinic Thessalonikis Private Clinic Single Member S.A.-Oncology ( Site 3703), Thessaloniki, Kentriki Makedonia, Greece
European Interbalkan Medical Center-Oncology Department ( Site 3702), Thessaloniki, , Greece
Emek Medical Center ( Site 2003), Afula, , Israel
Hadassah Medical Center ( Site 2004), Jerusalem, , Israel
Rabin Medical Center ( Site 2000), Petah Tikva, , Israel
Sheba Medical Center ( Site 2001), Ramat Gan, , Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401), Milan, Lombardia, Italy
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 1402), Siena, Toscana, Italy
AO Santa Maria della Misericordia ( Site 1403), Perugia, Umbria, Italy
Istituto Europeo di Oncologia IRCCS ( Site 1404), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi, Napoli, , Italy
Nagoya University Hospital ( Site 4201), Nagoya, Aichi, Japan
Capital, Coast and Hutt Valley District - Wellington Regional Hospital ( Site 1502), Newtown, Wellington, New Zealand
Harbour Cancer & Wellness ( Site 1500), Auckland, , New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2908), Bydgoszcz, Kujawsko-pomorskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2903), Siedlce, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Bialostockie Centrum Onkologii ( Site 2905), Bialystok, Podlaskie, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site, Gdańsk, Pomorskie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2907), Gliwice, Slaskie, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch, Kielce, Swietokrzyskie, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3601), Lisbon, Lisboa, Portugal
Centro Hospitalar de Lisboa Ocidental - Hospital De Sao Francisco Xavier ( Site 3602), Lisbon, Lisboa, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 3603), Lisbon, Lisboa, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3604), Porto, , Portugal
Medical Oncology Centre of Rosebank ( Site 4106), Johannesburg, Gauteng, South Africa
Wilgers Oncology Centre ( Site 4103), Pretoria, Gauteng, South Africa
Cape Town Oncology Trials ( Site 4100), Cape Town, Western Cape, South Africa
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit, Barcelona, Cataluna, Spain
Hospital Universitario Ramón y Cajal ( Site 1602), Madrid, Madrid, Comunidad De, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1603), Pozuelo de Alarcon, Madrid, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 1605), Málaga, Malaga, Spain
HOSPITAL CLINICO DE VALENCIA ( Site 1604), Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1601), Barcelona, , Spain
Skånes Universitetssjukhus Lund ( Site 3201), Lund, Skane Lan, Sweden
Sahlgrenska Universitetssjukhuset ( Site 3200), Gothenburg, Vastra Gotalands Lan, Sweden
Kantonsspital Graubünden-Medizin ( Site 1703), Chur, Grisons, Switzerland
UniversitätsSpital Zürich-Dermatology ( Site 1700), Zürich Flughafen, Zurich, Switzerland
Chang Gung Memorial Hospital at Kaohsiung ( Site 4000), Kaohsiung, , Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004), Tainan, , Taiwan
National Taiwan University Hospital ( Site 4001), Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 4003), Taoyuan, , Taiwan
I.E.U. Medical Point Hastanesi-Oncology ( Site 3005), Izmir, Karsiyaka, Izmir, Turkey
Hacettepe Universite Hastaneleri ( Site 3006), Ankara, , Turkey
Memorial Ankara Hastanesi-Medical Oncology ( Site 3010), Ankara, , Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 3002), Ankara, , Turkey
Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 3008), Istanbul, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3003), Istanbul, , Turkey
Bristol Haematology and Oncology Centre ( Site 1811), Bristol, Bristol, City Of, United Kingdom
Addenbrooke's Hospital ( Site 1800), Cambridge, Cambridgeshire, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust ( Site 1813), Cringleford, England, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 1804), London, Kensington And Chelsea, United Kingdom
University College London Hospital ( Site 1807), London, London, City Of, United Kingdom
Western General Hospital ( Site 1806), Edinburgh, Midlothian, United Kingdom
The Churchill Hospital ( Site 1805), Oxford, Oxfordshire, United Kingdom
St James's University Hospital-Leeds Cancer Centre ( Site 1808), Leeds, , United Kingdom
The Christie NHS Foundation Trust ( Site 1814), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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