RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-12-06

Study Completion:2035-12-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06077760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines. * Has no evidence of disease before randomization. * Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy. * No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab. * 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. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).	* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Received prior neoadjuvant therapy for their current NSCLC diagnosis. * Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis. * Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Active infection requiring systemic therapy.

Inclusion Criteria

Exclusion Criteria

* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
* Has no evidence of disease before randomization.
* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
* 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.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.

Contacts and Locations

Study Contact

Toll Free Number

CONTACT

1-888-577-8839

Trialsites@msd.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Locations (Sites)

Alaska Oncology and Hematology ( Site 0039)

Anchorage, Alaska, 99508

United States

YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)

Yuma, Arizona, 85364

United States

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

Los Angeles, California, 90095

United States

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

Orange, California, 92868

United States

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

Orange, California, 92868

United States

UCHealth Memorial Hospital-Heme Onc ( Site 0052)

Colorado Springs, Colorado, 80909

United States

Mid Florida Hematology and Oncology Center ( Site 0014)

Orange City, Florida, 32763

United States

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

Orlando, Florida, 32804

United States

Moffitt Cancer Center ( Site 0078)

Tampa, Florida, 33612

United States

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

Marietta, Georgia, 30060

United States

Beacon Cancer Care ( Site 0044)

Post Falls, Idaho, 83854

United States

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

Iowa City, Iowa, 52242

United States

Saint Elizabeth Healthcare ( Site 0092)

Edgewood, Kentucky, 41017

United States

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

Louisville, Kentucky, 40202

United States

University of Michigan Clinical Trials Office ( Site 0058)

Ann Arbor, Michigan, 48109

United States

Cancer and Hematology Centers of Western Michigan ( Site 4003)

Grand Rapids, Michigan, 49503

United States

St. Vincent Frontier Cancer Center ( Site 0043)

Billings, Montana, 59102

United States

NHO Revive Research Institute, LLC ( Site 4009)

Lincoln, Nebraska, 68506

United States

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

Hackensack, New Jersey, 07601

United States

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

Albany, New York, 12206

United States

Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)

Bronx, New York, 10461

United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0

Mineola, New York, 11501

United States

Laura and Isaac Perlmutter Cancer Center ( Site 0010)

New York, New York, 10016

United States

Icahn School of Medicine at Mount Sinai ( Site 0034)

New York, New York, 10029

United States

Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical

New York, New York, 10032

United States

Memorial Sloan Kettering Cancer Center ( Site 0029)

New York, New York, 10065

United States

Stony Brook University-Cancer Center ( Site 0072)

Stony Brook, New York, 11794

United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063)

Fargo, North Dakota, 58102

United States

Altru Health System ( Site 0040)

Grand Forks, North Dakota, 58201

United States

Summa Health ( Site 4011)

Akron, Ohio, 44304

United States

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028)

Cincinnati, Ohio, 45220

United States

University Hospitals Cleveland Medical Center ( Site 0023)

Cleveland, Ohio, 44106

United States

OSU Brain and Spine Hospital ( Site 0016)

Columbus, Ohio, 43210

United States

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)

Corvallis, Oregon, 97330

United States

Thomas Jefferson University - Clinical Research Institute ( Site 0006)

Philadelphia, Pennsylvania, 19107

United States

Medical University of South Carolina-Hollings Cancer Center ( Site 0050)

Charleston, South Carolina, 29425

United States

Sanford Cancer Center ( Site 0075)

Sioux Falls, South Dakota, 57104

United States

Thompson Cancer Survival Center ( Site 0097)

Knoxville, Tennessee, 37916

United States

SCRI Oncology Partners ( Site 7001)

Nashville, Tennessee, 37203

United States

UT Southwestern Medical Center ( Site 0061)

Dallas, Texas, 75390

United States

Inova Schar Cancer Institute ( Site 0003)

Fairfax, Virginia, 22031

United States

Swedish Medical Center-Swedish Cancer Institute ( Site 0088)

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-06

Study Completion Date2035-12-21

Study Record Updates

Study Start Date2023-12-06

Study Completion Date2035-12-21

Terms related to this study

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer