Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Arm A - Open Label Arms B and C - Double Blind

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Biological: Intismeran
    IM injection
    Other names:
    • V940
    • mRNA-4157
  • Biological: Pembrolizumab coformulated with berahyaluronidase alfa
    SC injection
    Other names:
    • MK-3475A
Experimental
Arm B: Intismeran
Participants will receive intismeran 1 mg via IM injection.
  • Biological: Intismeran
    IM injection
    Other names:
    • V940
    • mRNA-4157
Placebo Comparator
Arm C: Placebo
Participants will receive dose-matched placebo via IM injection.
  • Other: Placebo
    IM injection

Recruiting Locations

NHO Revive Research Institute, LLC ( Site 3218)
Lincoln, Nebraska 68506
Contact:
Study Coordinator
402-484-4900

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
Reno, Nevada 89502
Contact:
Study Coordinator
775-982-4000

Altru Health System ( Site 3254)
Grand Forks, North Dakota 58201
Contact:
Study Coordinator
701-780-5400

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.