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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)

RecruitingPhase 3Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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) c

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor โ‰ค4 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
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What it tests

  • Intismeran
  • Pembrolizumab coformulated with berahyaluronidase alfa
  • Placebo
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Where

124 sites
UC Davis Comprehensive Cancer Center ( Site 3204)
Sacramento, United States
University of Colorado Cancer Center ( Site 3268)
Aurora, United States
Smilow Cancer Center at Yale-New Haven ( Site 3253)
New Haven, United States
UF Health Cancer Center ( Site 3257)
Gainesville, United States
Illinois Cancer Care ( Site 7000)
Peoria, United States
Washington University School of Medicine ( Site 3279)
St Louis, United States
Billings Clinic ( Site 3255)
Billings, United States
NHO Revive Research Institute, LLC ( Site 3218)
Lincoln, United States

โ€ฆand 116 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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