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)
About this study
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
- Non-small Cell Lung Cancer
- Tested
- Intismeran, Pembrolizumab coformulated with berahyaluronidase alfa, Placebo
- Sponsor
- Merck Sharp & Dohme LLC
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Study condition: Non-small Cell Lung Cancer
- 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 10
- 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
Where
104 sites, 104 recruiting
Princess Alexandra Hospital ( Site 0503)
Brisbane, Queensland, Australia
One Clinical Research ( Site 0501)
Nedlands, Western Australia, Australia
Royal North Shore Hospital ( Site 0502)
St Leonards, New South Wales, Australia
Hospital Sírio Libanês ( Site 3611)
São Paulo, Brazil
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)
Hamilton, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)
Kingston, Ontario, Canada
and 98 more sites on ClinicalTrials.gov
Contact
-
Toll Free Number
1-888-577-8839 Trialsites@msd.com
Potential match only. Final eligibility is determined by the study team.