Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07513376

PHASE3

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

View on ClinicalTrials.gov

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

2026-08-26

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer

Interventions

BIOLOGICAL

Intismeran

IM injection

BIOLOGICAL

Pembrolizumab coformulated with berahyaluronidase alfa

SC injection

OTHER

Placebo

IM injection

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology * Has undergone a complete surgical resection of the primary NSCLC * Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC * Has provided a tissue sample from recent surgery along with the required blood sample * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs * Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy other than those permitted in protocol * Has history of stem cell/solid organ transplant * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Locations (76)

UC Davis Comprehensive Cancer Center ( Site 3204)

Sacramento, California, United States

Smilow Cancer Center at Yale-New Haven ( Site 3253)

New Haven, Connecticut, 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

White Plains Hospital ( Site 3213)

White Plains, New York, United States

Charles George VA Medical Center ( Site 3233)

Asheville, North Carolina, United States

WakeMed Raleigh Campus ( Site 3214)

Raleigh, North Carolina, United States

Altru Health System ( Site 3254)

Grand Forks, North 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

West Virginia University ( Site 3237)

Morgantown, West Virginia, 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

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

Hamilton, Ontario, Canada

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)

Kingston, Ontario, Canada

Centre Hospitalier de l'Université de Montréal ( Site 2501)

Montreal, Quebec, Canada

Hôpital Foch ( Site 2604)

Suresnes, Hauts-de-Seine, France

Thoraxklinik-Heidelberg gGmbH ( Site 2703)

Heidelberg, Baden-Wurttemberg, Germany

Augusta-Kranken-Anstalt ( Site 2702)

Bochum, North Rhine-Westphalia, 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

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

Sheba Medical Center ( Site 3302)

Ramat Gan, Israel

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)

Milan, Lombardy, Italy

Azienda Ospedaliera Universitaria Careggi ( Site 2806)

Florence, Tuscany, 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

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

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

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 GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)

Madrid, Spain

Hospital Clinico San Carlos ( Site 0303)

Madrid, Spain

Hospital Universitario Virgen Macarena ( Site 0306)

Seville, 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)

Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)

Kayseri, Turkey (Türkiye)

St Bartholomew's Hospital ( Site 0400)

London, London, City of, United Kingdom

Singleton Hospital ( Site 0403)

Swansea, United Kingdom

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (76)