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A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery. People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer. The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.
Official title: A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
876
Start Date
2026-05-04
Completion Date
2038-05-11
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Intismeran
IM injection
Pembrolizumab coformulated with berahyaluronidase alfa
SC injection
Placebo
IM injection
Locations (117)
UC Davis Comprehensive Cancer Center ( Site 3204)
Sacramento, California, United States
University of Colorado Cancer Center ( Site 3268)
Aurora, Colorado, United States
Smilow Cancer Center at Yale-New Haven ( Site 3253)
New Haven, Connecticut, United States
UF Health Cancer Center ( Site 3257)
Gainesville, Florida, United States
Illinois Cancer Care ( Site 7000)
Peoria, Illinois, United States
Washington University School of Medicine ( Site 3279)
St Louis, Missouri, United States
Billings Clinic ( Site 3255)
Billings, Montana, United States
NHO Revive Research Institute, LLC ( Site 3218)
Lincoln, Nebraska, United States
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
Reno, Nevada, United States
New York Oncology Hematology, P.C. ( Site 9000)
Albany, New York, United States
White Plains Hospital ( Site 3213)
White Plains, New York, United States
Charles George VA Medical Center ( Site 3233)
Asheville, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center ( Site 3250)
Chapel Hill, North Carolina, United States
WakeMed Raleigh Campus ( Site 3214)
Raleigh, North Carolina, United States
Sanford Fargo Medical Center ( Site 3236)
Fargo, North Dakota, United States
Altru Health System ( Site 3254)
Grand Forks, North Dakota, United States
Perelman Center for Advanced Medicine ( Site 3205)
Philadelphia, Pennsylvania, United States
Sanford Cancer Center ( Site 3266)
Sioux Falls, South Dakota, United States
Avera Cancer Institute ( Site 3209)
Sioux Falls, South Dakota, United States
The University of Tennessee Medical Center ( Site 3223)
Knoxville, Tennessee, United States
Hematology Oncology Associates of Fredericksburg ( Site 3275)
Fredericksburg, Virginia, United States
West Virginia University ( Site 3237)
Morgantown, West Virginia, United States
Gundersen Health System ( Site 3200)
La Crosse, Wisconsin, United States
Royal North Shore Hospital ( Site 0502)
St Leonards, New South Wales, Australia
Princess Alexandra Hospital ( Site 0503)
Brisbane, Queensland, Australia
One Clinical Research ( Site 0501)
Nedlands, Western Australia, Australia
Hospital de Clínicas de Passo Fundo ( Site 3601)
Pasos Fundo, Rio Grande do Sul, Brazil
Hospital Sírio Libanês ( Site 3611)
São Paulo, Brazil
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)
Hamilton, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)
Kingston, Ontario, Canada
The Ottawa Hospital Cancer Centre ( Site 2508)
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 2501)
Montreal, Quebec, Canada
Clínica MEDS La Dehesa ( Site 3708)
Lo Barnechea, Region M. de Santiago, Chile
Centro de Oncología de Precisión ( Site 3706)
Santiago, Region M. de Santiago, Chile
FALP-UIDO ( Site 3701)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 3700)
Santiago, Region M. de Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 3704)
Viña del Mar, Valparaiso, Chile
Bradford Hill Norte ( Site 3705)
Antofagasta, Chile
Promotora Médica Las Américas S.A. ( Site 3800)
Medellín, Antioquia, Colombia
Clinica Somer ( Site 3802)
Rionegro, Antioquia, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3806)
Bogotá, Bogota D.C., Colombia
Clínica Universitaria Colombia ( Site 3803)
Bogotá, Bogota D.C., Colombia
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 3804)
Bogota, Cundinamarca, Colombia
Instituto Médico de Alta Tecnología S.A.S - IMAT S.A.S ( Site 3801)
Montería, Departamento de Córdoba, Colombia
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 2605)
Rennes, Brittany Region, France
Hôpital Foch ( Site 2604)
Suresnes, Hauts-de-Seine, France
CHU GABRIEL MONTPIED ( Site 2608)
Clermont-Ferrand, Puy-de-Dome, France
Thoraxklinik-Heidelberg gGmbH ( Site 2703)
Heidelberg, Baden-Wurttemberg, Germany
Augusta-Kranken-Anstalt ( Site 2702)
Bochum, North Rhine-Westphalia, Germany
SRH Wald-Klinikum Gera ( Site 2700)
Gera, Thuringia, Germany
Errikos Dunant Hospital Center ( Site 5004)
Athens, Attica, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001)
Athens, Attica, Greece
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003)
Athens, Attica, Greece
European Interbalkan Medical Center-Oncology Department ( Site 5000)
Thessaloniki, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)
Pécs, Baranya, Hungary
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)
Kecskemét, Bács-Kiskun county, Hungary
Nograd Varmegyei Szent Lazar Korhaz ( Site 4410)
Salgótarján, Nógrád megye, Hungary
Reformatus Pulmonologiai Centrum ( Site 4403)
Törökbálint, Pest County, Hungary
Országos Onkológiai Intézet ( Site 4405)
Budapest, Hungary
Rambam Health Care Campus ( Site 3303)
Haifa, Israel
Shaare Zedek Medical Center ( Site 3301)
Jerusalem, Israel
Hadassah Medical Center ( Site 3305)
Jerusalem, Israel
Meir medical center ( Site 3306)
Kfar Saba, Israel
Rabin Medical Center ( Site 3304)
Petah Tikva, Israel
Sheba Medical Center ( Site 3302)
Ramat Gan, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 2804)
Bergamo, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 2806)
Florence, Tuscany, Italy
AO Santa Maria della Misericordia ( Site 2809)
Perugia, Umbria, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)
Novara, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)
Roma, Italy
Hospital of the University of Occupational and Environmental Health, Japan ( Site 5516)
Kitakyushu, Fukuoka, Japan
Fukushima Medical University Hospital ( Site 5501)
Fukushima, Japan
Ziekenhuis St. Jansdal ( Site 4800)
Harderwijk, Gelderland, Netherlands
Radboudumc ( Site 4806)
Nijmegen, Gelderland, Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)
Amsterdam, North Holland, Netherlands
Elisabeth-TweeSteden Ziekenhuis ( Site 4801)
Tilburg, North Holland, Netherlands
Isala, locatie Zwolle ( Site 4804)
Zwolle, Overijssel, Netherlands
Frisius Medisch Centrum ( Site 4808)
Leeuwarden, Provincie Friesland, Netherlands
Meander Medisch Centrum ( Site 4802)
Amersfoort, Utrecht, Netherlands
University Medical Center Groningen ( Site 4807)
Groningen, Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)
Poznan, Greater Poland Voivodeship, Poland
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200)
Warsaw, Masovian Voivodeship, Poland
IP Clinic ( Site 4204)
Lodz, Łódź Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206)
Chęciny, Świętokrzyskie Voivodeship, Poland
National Cancer Center ( Site 5202)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 5200)
Seongnam-si, Kyonggi-do, South Korea
The Catholic University Of Korea St. Vincent's Hospital ( Site 5203)
Suwon, Kyonggi-do, South Korea
Chungbuk National University Hospital ( Site 5201)
Cheongju-si, North Chungcheong, South Korea
Asan Medical Center ( Site 5205)
Seoul, South Korea
Samsung Medical Center ( Site 5206)
Seoul, South Korea
ICO - Hospital Duran i Reynals ( Site 0301)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Cruces ( Site 0308)
Barakaldo, Bizkaia, Spain
Hospital Universitari Vall d'Hebron ( Site 0300)
Barcelona, Catalonia, Spain
Hospital Virgen de la Victoria ( Site 0309)
Málaga, Malaga, Spain
Hospital Universitario de Badajoz ( Site 0305)
Badajoz, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)
Madrid, Spain
Hospital Clinico San Carlos ( Site 0303)
Madrid, Spain
Hospital Universitario Virgen Macarena ( Site 0306)
Seville, Spain
Hospital General de Valencia ( Site 0304)
Valencia, Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)
Kaohsiung City, Taiwan
China Medical University Hospital ( Site 5303)
Taichung, Taiwan
Taichung Veterans General Hospital ( Site 5301)
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 5300)
Tainan, Taiwan
Taipei Medical University Hospital ( Site 5305)
Taipei, Taiwan
Adana Medical Park Seyhan Hastanesi ( Site 4302)
Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)
Ankara, Turkey (Türkiye)
Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309)
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 4306)
Ankara, Turkey (Türkiye)
İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)
Istanbul, Turkey (Türkiye)
KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308)
Istanbul, Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 4301)
Izmir, Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)
Kayseri, Turkey (Türkiye)
St Bartholomew's Hospital ( Site 0400)
London, London, City of, United Kingdom
Charing Cross Hospital ( Site 0407)
London, London, City of, United Kingdom
Singleton Hospital ( Site 0403)
Swansea, United Kingdom