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A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
Sponsor: Merck Sharp & Dohme LLC
Summary
The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.
Official title: A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma (INTerpath-004).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
272
Start Date
2024-04-10
Completion Date
2032-06-08
Last Updated
2025-09-02
Healthy Volunteers
No
Conditions
Interventions
Intismeran autogene
IM injection
Pembrolizumab
IV infusion
Placebo
IM injection
Locations (63)
City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)
Duarte, California, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 0108)
San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute-GU ( Site 0101)
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center ( Site 0100)
New York, New York, United States
Duke Cancer Institute ( Site 0106)
Durham, North Carolina, United States
Abramson Cancer Center ( Site 0107)
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0111)
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center ( Site 0110)
Dallas, Texas, United States
Hospital Británico de Buenos Aires-Oncology ( Site 1106)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 1101)
Buenos Aires, Buenos Aires F.D., Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)
Buenos Aires, Buenos Aires F.D., Argentina
Centro Privado de RMI Rio Cuarto ( Site 1104)
Río Cuarto, Córdoba Province, Argentina
Fundacion Estudios Clinicos ( Site 1111)
Rosario, Santa Fe Province, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502)
Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 1501)
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland, Australia
Fiona Stanley Hospital-Medical Oncology ( Site 1503)
Murdoch, Western Australia, Australia
BC Cancer Vancouver ( Site 0005)
Vancouver, British Columbia, Canada
CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008)
Québec, Quebec, Canada
FALP-UIDO ( Site 1202)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 1201)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 1200)
Viña del Mar, Región de Valparaíso, Chile
CENTRE LEON BERARD ( Site 0305)
Lyon Cedex08, Auvergne-Rhône-Alpes, France
CHU Besançon ( Site 0302)
Besançon, Doubs, France
Institut Claudius Regaud ( Site 0303)
Toulouse, Haute-Garonne, France
Hôpital Européen Georges Pompidou ( Site 0300)
Paris, France
Gustave Roussy ( Site 0304)
Villejuif, Île-de-France Region, France
Klinikum Stuttgart - Katharinenhospital ( Site 0400)
Stuttgart, Baden-Wurttemberg, Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
Munich, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)
Dresden, Saxony, Germany
Universitätsklinikum Jena ( Site 0402)
Jena, Thuringia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0401)
Berlin, Germany
Asklepios Altona-Department of Urology ( Site 0410)
Hamburg, Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0501)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0500)
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0504)
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria di Parma ( Site 0503)
Parma, Italy
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( S
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Hospital ( Site 1600)
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 1603)
Seoul, South Korea
Asan Medical Center ( Site 1602)
Seoul, South Korea
Samsung Medical Center ( Site 1601)
Seoul, South Korea
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0801)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0800)
Barcelona, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0802)
Seville, Spain
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
China Medical University Hospital-Department of Urology ( Site 1702)
Taichung, Taiwan
Taichung Veterans General Hospital ( Site 1704)
Taichung, Taiwan
Taipei Veterans General Hospital ( Site 1703)
Taipei, Taiwan
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0901)
Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi-Oncology ( Site 0902)
Ankara, Turkey (Türkiye)
Ege Universitesi Hastanesi-Medical Oncology ( Site 0903)
Izmir, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1004)
Cambridge, Cambridgeshire, United Kingdom
Gartnavel General Hospital-Clinical Trials Unit ( Site 1002)
Glasgow, Glasgow City, United Kingdom
St Bartholomew's Hospital ( Site 1000)
London, London, City of, United Kingdom
Western General Hospital ( Site 1003)
Edinburgh, Midlothian, United Kingdom
The Christie NHS Foundation Trust ( Site 1001)
Manchester, United Kingdom