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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
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
Intismeran
IM injection
Pembrolizumab coformulated with berahyaluronidase alfa
SC injection
Placebo
IM injection
Locations (29)
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
WakeMed Raleigh Campus ( Site 3214)
Raleigh, North Carolina, United States
Altru Health System ( Site 3254)
Grand Forks, North 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
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
European Interbalkan Medical Center-Oncology Department ( Site 5000)
Thessaloniki, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)
Pécs, Baranya, Hungary
Rambam Health Care Campus ( Site 3303)
Haifa, Israel
Hadassah Medical Center ( Site 3305)
Jerusalem, Israel
Ziekenhuis St. Jansdal ( Site 4800)
Harderwijk, Gelderland, Netherlands
Radboudumc ( Site 4806)
Nijmegen, Gelderland, Netherlands
Meander Medisch Centrum ( Site 4802)
Amersfoort, Utrecht, Netherlands
University Medical Center Groningen ( Site 4807)
Groningen, Netherlands
IP Clinic ( Site 4204)
Lodz, Łódź Voivodeship, Poland
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
Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)
Ankara, Turkey (Türkiye)