A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
Recruiting · NCT07221474 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Inclusion Criteria include, but are not limited to:
- Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
- Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
- Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
- Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Hepatitis B surface antigen (HBsAg) positive participants 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. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has a life expectancy of at least 3 months
- Has adequate organ function
Exclusion criteria
- Exclusion Criteria include, but are not limited to:
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
- Has received prior systemic anticancer therapy for their metastatic NSCLC
- Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
- Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
Where it is running
55 locations listed across 11 US states.
- Moffitt Cancer Center ( Site 0021) - Tampa, Florida, United States
- VA Ann Arbor Healthcare System ( Site 0019) - Ann Arbor, Michigan, United States
- Washington University School of Medicine ( Site 0024) - St Louis, Missouri, United States
- Valley Health Systems - Ridgewood Campus ( Site 0010) - Paramus, New Jersey, United States
- New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001) - Albany, New York, United States
- Cleveland Clinic - Ohio ( Site 0016) - Cleveland, Ohio, United States
- Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025) - Corvallis, Oregon, United States
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000) - Nashville, Tennessee, United States
- Texas Oncology - Central/South Texas ( Site 8002) - Austin, Texas, United States
- Virginia Cancer Specialists ( Site 0003) - Fairfax, Virginia, United States
- Swedish Medical Center-Swedish Cancer Institute ( Site 0023) - Seattle, Washington, United States
- Hacettepe Universitesi Tıp Fakultesi ( Site 1400) - Ankara, Turkey (Türkiye)
- Memorial Ankara Hastanesi ( Site 1401) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi ( Site 1402) - Ankara, Turkey (Türkiye)
- Bradford Hill Norte ( Site 0308) - Antofagasta, Chile
- Hospital Universitari Vall d''Hebron ( Site 1310) - Barcelona, Spain
- Koç Üniversitesi Hastanesi ( Site 1403) - Istanbul, Turkey (Türkiye)
- Hospital Ramon y Cajal ( Site 1314) - Madrid, Spain
- Hospital Clinico San Carlos... ( Site 1313) - Madrid, Spain
- Ospedale San Raffaele-Oncologia Medica ( Site 1002) - Milan, Italy
- Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000) - Milan, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001) - Roma, Italy
- Asan Medical Center ( Site 0503) - Seoul, South Korea
- Samsung Medical Center ( Site 0502) - Seoul, South Korea
- Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312) - Seville, Spain
- China Medical University Hospital ( Site 0606) - Taichung, Taiwan
- National Cheng Kung University Hospital ( Site 0601) - Tainan, Taiwan
- Mackay Memorial Hospital ( Site 0604) - Taipei, Taiwan
- National Taiwan University Cancer Center (NTUCC) ( Site 0600) - Taipei, Taiwan
- Taipei Veterans General Hospital ( Site 0602) - Taipei, Taiwan
- Chang Gung Medical Foundation-Linkou Branch ( Site 0605) - Taoyuan, Taiwan
- ICO L Hospitalet ( Site 1311) - Hospitalet, Barcelona, Spain
- Instituto Alexander Fleming ( Site 0201) - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires ( Site 0200) - Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205) - Mar del Plata, Buenos Aires, Argentina
- Clinica Adventista Belgrano ( Site 0206) - Caba., Buenos Aires F.D., Argentina
- Hospital Jerez de la Frontera-UGC Oncología ( Site 1315) - Jerez de la Frontera, Cadiz, Spain
- Centre Georges François Leclerc ( Site 0805) - Dijon, Cote-d Or, France
- Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004) - Ravenna, Emilia-Romagna, Italy
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101) - Poznan, Greater Poland Voivodeship, Poland
- National Cancer Center ( Site 0504) - Goyang-si, Kyonggi-do, South Korea
- Seoul National University Bundang Hospital ( Site 0500) - Seongnam-si, Kyonggi-do, South Korea
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100) - Warsaw, Masovian Voivodeship, Poland
- Westmead Hospital ( Site 0400) - Westmead, New South Wales, Australia
- Chungbuk National University Hospital-Internal medicine ( Site 0501) - Cheongju-si, North Chungcheong, South Korea
- Institut de Cancérologie de l'Ouest ( Site 0801) - Angers, Pays de la Loire Region, France
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102) - Przemyśl, Podkarpackie Voivodeship, Poland
- CHU GABRIEL MONTPIED ( Site 0802) - Clermont-Ferrand, Puy-de-Dome, France
- Princess Alexandra Hospital ( Site 0403) - Woolloongabba, Queensland, Australia
- Centro de Estudios Clínicos SAGA ( Site 0307) - Santiago, Region M. de Santiago, Chile
- FALP ( Site 0300) - Santiago, Region M. de Santiago, Chile
- Bradfordhill ( Site 0301) - Santiago, Region M. de Santiago, Chile
- Fundacion Estudios Clinicos ( Site 0207) - Rosario, Santa Fe Province, Argentina
- Sanatorio Parque ( Site 0203) - Rosario, Santa Fe Province, Argentina
- One Clinical Research ( Site 0402) - Nedlands, Western Australia, Australia