Recruiting
Phase 3

Intismeran & Pembrolizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07513376

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intismeran

Pembrolizumab coformulated with berahyaluronidase alfa

Placebo

Study Details

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT07513376

Start date

May 4, 2026

Status verified date

Sep, 2026

Completion date

May 11, 2038

Anticipated

Primary completion date

Aug 22, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

876 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa

Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.

experimental: Arm B: Intismeran

Participants will receive intismeran 1 mg via IM injection.

placebo comparator: Arm C: Placebo

Participants will receive dose-matched placebo via IM injection.

Interventions

Intismeran

IM injection

Pembrolizumab coformulated with berahyaluronidase alfa

SC injection

Placebo

IM injection

Primary outcome measure

  • 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 [ Time Frame: Up to approximately 98 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

UC Davis Comprehensive Cancer Center ( Site 3204)

Recruiting

Sacramento, California, United States, 95817

Contacts

Study Coordinator

916-734-5959

University of Colorado Cancer Center ( Site 3268)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-848-0300

Smilow Cancer Center at Yale-New Haven ( Site 3253)

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Study Coordinator

203-688-4242

Illinois Cancer Care ( Site 7000)

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Study Coordinator

309-240-6040

Washington University School of Medicine ( Site 3279)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-362-5000

Billings Clinic ( Site 3255)

Recruiting

Billings, Montana, United States, 59101

Contacts

Study Coordinator

406-435-7480

NHO Revive Research Institute, LLC ( Site 3218)

Recruiting

Lincoln, Nebraska, United States, 68506

Contacts

Study Coordinator

402-484-4900

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)

Recruiting

Reno, Nevada, United States, 89502

Contacts

Study Coordinator

775-982-4000

New York Oncology Hematology, P.C. ( Site 9000)

Recruiting

Albany, New York, United States, 12206

Contacts

Study Coordinator

518-489-0044

White Plains Hospital ( Site 3213)

Recruiting

White Plains, New York, United States, 10601

Contacts

Study Coordinator

914-849-7500

Charles George VA Medical Center ( Site 3233)

Recruiting

Asheville, North Carolina, United States, 28805

Contacts

Study Coordinator

828-298-7911

UNC Lineberger Comprehensive Cancer Center ( Site 3250)

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Study Coordinator

919-966-4432

WakeMed Raleigh Campus ( Site 3214)

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Study Coordinator

919-350-2873

Sanford Fargo Medical Center ( Site 3236)

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Study Coordinator

701-234-7563

Altru Health System ( Site 3254)

Recruiting

Grand Forks, North Dakota, United States, 58201

Contacts

Study Coordinator

701-780-5400

Perelman Center for Advanced Medicine ( Site 3205)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

267-275-3770

Sanford Cancer Center ( Site 3266)

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Study Coordinator

605-312-3250

Avera Cancer Institute ( Site 3209)

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

605-322-3000

The University of Tennessee Medical Center ( Site 3223)

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Study Coordinator

865-305-8780

Hematology Oncology Associates of Fredericksburg ( Site 3275)

Recruiting

Fredericksburg, Virginia, United States, 22408

Contacts

Study Coordinator

540-371-0079

West Virginia University ( Site 3237)

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Study Coordinator

304-598-4500

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Study Coordinator

905-387-9495

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Study Coordinator

6135496666

Centre Hospitalier de l'Université de Montréal ( Site 2501)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Study Coordinator

5148908000x26832

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.