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ACTIVE NOT RECRUITING
NCT06307431
PHASE2

A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Intismeran autogene

IM injection

BIOLOGICAL

Pembrolizumab

IV infusion

BIOLOGICAL

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