RecruitingPhase 3NCT06077760

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

868 participants

Start Date

Dec 6, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (V940-002) is testing a personalized mRNA cancer vaccine called intismeran autogene (V940), combined with the immunotherapy drug pembrolizumab, versus pembrolizumab with a placebo — in people with non-small cell lung cancer (NSCLC) who have had their tumors completely removed. **You may be eligible if...** - You have had surgery to completely remove your NSCLC with clear margins - Your cancer is pathological Stage II, IIIA, or IIIB (N2) — meaning it was found to be locally advanced at time of surgery - Your tumor is either squamous or non-squamous type **You may NOT be eligible if...** - Your cancer was not completely removed - Your cancer is a different stage (Stage I or Stage IV) - You have already received systemic cancer treatment for this NSCLC Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIntismeran autogene

IM injection

BIOLOGICALPembrolizumab

IV infusion

OTHERPlacebo

IM injection

Locations(229)

Alaska Oncology and Hematology ( Site 0039)

Anchorage, Alaska, United States

The University of Arizona Cancer Center - North Campus ( Site 0071)

Tucson, Arizona, United States

YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)

Yuma, Arizona, United States

UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian ( Site 4042)

Newport Beach, California, United States

Hoag Memorial Hospital Presbyterian ( Site 4048)

Newport Beach, California, United States

St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)

Orange, California, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)

Orange, California, United States

UCHealth Memorial Hospital-Heme Onc ( Site 0052)

Colorado Springs, Colorado, United States

George Washington University Medical Faculty Associates ( Site 4064)

Washington D.C., District of Columbia, United States

Mayo Clinic Florida ( Site 4043)

Jacksonville, Florida, United States

Miami Cancer Institute at Baptist Health, Inc. ( Site 4047)

Miami, Florida, United States

Mid Florida Hematology and Oncology Center ( Site 0014)

Orange City, Florida, United States

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)

Orlando, Florida, United States

Moffitt Cancer Center ( Site 0078)

Tampa, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)

Marietta, Georgia, United States

Southeastern Regional Medical Center ( Site 0098)

Newnan, Georgia, United States

Beacon Cancer Care ( Site 0044)

Post Falls, Idaho, United States

Illinois Cancer Care ( Site 7003)

Peoria, Illinois, United States

University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)

Iowa City, Iowa, United States

Saint Elizabeth Healthcare ( Site 0092)

Edgewood, Kentucky, United States

The University of Louisville, James Graham Brown Cancer Center ( Site 0037)

Louisville, Kentucky, United States

LSU Health Baton Rouge North Clinic ( Site 4040)

Baton Rouge, Louisiana, United States

Our Lady of the Lake RMC-Clinical Research ( Site 4050)

Baton Rouge, Louisiana, United States

University of Michigan Clinical Trials Office ( Site 0058)

Ann Arbor, Michigan, United States

Cancer and Hematology Centers of Western Michigan ( Site 4003)

Grand Rapids, Michigan, United States

St. Vincent Frontier Cancer Center ( Site 0043)

Billings, Montana, United States

NHO Revive Research Institute, LLC ( Site 4009)

Lincoln, Nebraska, United States

Memorial Sloan Kettering - Basking Ridge ( Site 4056)

Basking Ridge, New Jersey, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)

Hackensack, New Jersey, United States

Memorial Sloan Kettering - Monmouth ( Site 4057)

Middletown, New Jersey, United States

Memorial Sloan Kettering - Bergen ( Site 4059)

Montvale, New Jersey, United States

Atlantic Health Morristown Medical Center ( Site 4018)

Morristown, New Jersey, United States

New York Oncology Hematology, P.C. ( Site 4012)

Albany, New York, United States

Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)

Commack, New York, United States

Memorial Sloan Kettering - Westchester ( Site 4058)

Harrison, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)

Mineola, New York, United States

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)