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)

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07513376
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intismeran — BIOLOGICAL
    IM injection
  • Pembrolizumab coformulated with berahyaluronidase alfa — BIOLOGICAL
    SC injection
  • Placebo — OTHER
    IM injection

Study Details

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.

Key Dates

Start date
May 4, 2026
Status verified
Jun 2026
Primary completion
Aug 22, 2034
Completion
May 11, 2038

Study Design

Enrollment
876 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (3)

FacilityCityStateZIPSite coordinators
NHO Revive Research Institute, LLC ( Site 3218)LincolnNebraska68506
Study Coordinator
402-484-4900
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)RenoNevada89502
Study Coordinator
775-982-4000
Altru Health System ( Site 3254)Grand ForksNorth Dakota58201
Study Coordinator
701-780-5400

Find similar trials in Lincoln, NE

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
NHO Revive Research Institute, LLC· Lincoln, NERenown Regional Medical Center-Renown Health Medical Oncology· Reno, NVAltru Health System· Grand Forks, ND

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