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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

2026-07-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Intismeran

IM injection

BIOLOGICAL

Pembrolizumab coformulated with berahyaluronidase alfa

SC injection

OTHER

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)