RecruitingRecruiting
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)
NCT07513376 · Merck Sharp & Dohme LLC
In plain English
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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)
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 876 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-05-04
Estimated completion: 2038-05-11
Last updated: 2026-09-14
Interventions
Biological: IntismeranBiological: Pembrolizumab coformulated with berahyaluronidase alfaOther: Placebo
Primary outcomes
- • Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C (Up to approximately 98 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: ModernaTX, Inc.
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (86)
UC Davis Comprehensive Cancer Center ( Site 3204)Recruiting
Sacramento, California, United States
University of Colorado Cancer Center ( Site 3268)Recruiting
Aurora, Colorado, United States
Smilow Cancer Center at Yale-New Haven ( Site 3253)Recruiting
New Haven, Connecticut, United States
Illinois Cancer Care ( Site 7000)Recruiting
Peoria, Illinois, United States
Billings Clinic ( Site 3255)Recruiting
Billings, Montana, United States
NHO Revive Research Institute, LLC ( Site 3218)Recruiting
Lincoln, Nebraska, United States
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)Recruiting
Reno, Nevada, United States
New York Oncology Hematology, P.C. ( Site 9000)Recruiting
Albany, New York, United States
White Plains Hospital ( Site 3213)Recruiting
White Plains, New York, United States
Charles George VA Medical Center ( Site 3233)Recruiting
Asheville, North Carolina, United States
WakeMed Raleigh Campus ( Site 3214)Recruiting
Raleigh, North Carolina, United States
Altru Health System ( Site 3254)Recruiting
Grand Forks, North Dakota, United States
Perelman Center for Advanced Medicine ( Site 3205)Recruiting
Philadelphia, Pennsylvania, United States
Sanford Cancer Center ( Site 3266)Recruiting
Sioux Falls, South Dakota, United States
Avera Cancer Institute ( Site 3209)Recruiting
Sioux Falls, South Dakota, United States
The University of Tennessee Medical Center ( Site 3223)Recruiting
Knoxville, Tennessee, United States
Hematology Oncology Associates of Fredericksburg ( Site 3275)Recruiting
Fredericksburg, Virginia, United States
West Virginia University ( Site 3237)Recruiting
Morgantown, West Virginia, United States
Royal North Shore Hospital ( Site 0502)Recruiting
St Leonards, New South Wales, Australia
Princess Alexandra Hospital ( Site 0503)Recruiting
Brisbane, Queensland, Australia
One Clinical Research ( Site 0501)Recruiting
Nedlands, Western Australia, Australia
Hospital Sírio Libanês ( Site 3611)Recruiting
São Paulo, Brazil
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)Recruiting
Hamilton, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)Recruiting
Kingston, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 2501)Recruiting
Montreal, Quebec, Canada
Hôpital Foch ( Site 2604)Recruiting
Suresnes, Hauts-de-Seine, France
Thoraxklinik-Heidelberg gGmbH ( Site 2703)Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Augusta-Kranken-Anstalt ( Site 2702)Recruiting
Bochum, North Rhine-Westphalia, Germany
Errikos Dunant Hospital Center ( Site 5004)Recruiting
Athens, Attica, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001)Recruiting
Athens, Attica, Greece
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003)Recruiting
Athens, Attica, Greece
European Interbalkan Medical Center-Oncology Department ( Site 5000)Recruiting
Thessaloniki, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)Recruiting
Pécs, Baranya, Hungary
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)Recruiting
Miskolc, Borsod-Abauj Zemplen county, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)Recruiting
Kecskemét, Bács-Kiskun county, Hungary
Nograd Varmegyei Szent Lazar Korhaz ( Site 4410)Recruiting
Salgótarján, Nógrád megye, Hungary
Reformatus Pulmonologiai Centrum ( Site 4403)Recruiting
Törökbálint, Pest County, Hungary
Országos Onkológiai Intézet ( Site 4405)Recruiting
Budapest, Hungary
Rambam Health Care Campus ( Site 3303)Recruiting
Haifa, Israel
Shaare Zedek Medical Center ( Site 3301)Recruiting
Jerusalem, Israel
Hadassah Medical Center ( Site 3305)Recruiting
Jerusalem, Israel
Meir medical center ( Site 3306)Recruiting
Kfar Saba, Israel
Rabin Medical Center ( Site 3304)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 3302)Recruiting
Ramat Gan, Israel
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)Recruiting
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 2806)Recruiting
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)Recruiting
Novara, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)Recruiting
Roma, Italy
Ziekenhuis St. Jansdal ( Site 4800)Recruiting
Harderwijk, Gelderland, Netherlands
Radboudumc ( Site 4806)Recruiting
Nijmegen, Gelderland, Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)Recruiting
Amsterdam, North Holland, Netherlands
Elisabeth-TweeSteden Ziekenhuis ( Site 4801)Recruiting
Tilburg, North Holland, Netherlands
Frisius Medisch Centrum ( Site 4808)Recruiting
Leeuwarden, Provincie Friesland, Netherlands
Meander Medisch Centrum ( Site 4802)Recruiting
Amersfoort, Utrecht, Netherlands
University Medical Center Groningen ( Site 4807)Recruiting
Groningen, Netherlands
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200)Recruiting
Warsaw, Masovian Voivodeship, Poland
IP Clinic ( Site 4204)Recruiting
Lodz, Łódź Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206)Recruiting
Chęciny, Świętokrzyskie Voivodeship, Poland
National Cancer Center ( Site 5202)Recruiting
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 5200)Recruiting
Seongnam-si, Kyonggi-do, South Korea
The Catholic University Of Korea St. Vincent's Hospital ( Site 5203)Recruiting
Suwon, Kyonggi-do, South Korea
Chungbuk National University Hospital ( Site 5201)Recruiting
Cheongju-si, North Chungcheong, South Korea
Asan Medical Center ( Site 5205)Recruiting
Seoul, South Korea
ICO - Hospital Duran i Reynals ( Site 0301)Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Cruces ( Site 0308)Recruiting
Barakaldo, Bizkaia, Spain
Hospital Universitari Vall d'Hebron ( Site 0300)Recruiting
Barcelona, Catalonia, Spain
Hospital Virgen de la Victoria ( Site 0309)Recruiting
Málaga, Malaga, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)Recruiting
Madrid, Spain
Hospital Clinico San Carlos ( Site 0303)Recruiting
Madrid, Spain
Hospital Universitario Virgen Macarena ( Site 0306)Recruiting
Seville, Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)Recruiting
Kaohsiung City, Taiwan
China Medical University Hospital ( Site 5303)Recruiting
Taichung, Taiwan
Taichung Veterans General Hospital ( Site 5301)Recruiting
Taichung, Taiwan
National Cheng Kung University Hospital ( Site 5300)Recruiting
Tainan, Taiwan
Taipei Medical University Hospital ( Site 5305)Recruiting
Taipei, Taiwan
Adana Medical Park Seyhan Hastanesi ( Site 4302)Recruiting
Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)Recruiting
Ankara, Turkey (Türkiye)
Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 4306)Recruiting
Ankara, Turkey (Türkiye)
İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)Recruiting
Istanbul, Turkey (Türkiye)
KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308)Recruiting
Istanbul, Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 4301)Recruiting
Izmir, Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)Recruiting
Kayseri, Turkey (Türkiye)
St Bartholomew's Hospital ( Site 0400)Recruiting
London, London, City of, United Kingdom
Singleton Hospital ( Site 0403)Recruiting
Swansea, United Kingdom