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Clinical Trials in the USA / NCT07221474
Recruiting Phase 2

A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)

NCT07221474 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2025-12-12
Last updated
2026-08-21

Condition(s) studied

Squamous Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Intismeran Autogene →Pembrolizumab →Carboplatin →Paclitaxel →Nab-paclitaxel →Placebo

Intismeran Autogene: 1 mg Intramuscular (IM) Injection

Pembrolizumab: 200 mg IV Infusion

Carboplatin: Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion

Paclitaxel: 200 or 175 mg/m\^2 IV Infusion

Nab-paclitaxel: 100 mg/m\^2 IV Infusion

Placebo: Placebo matched to Intismeran Autogene IM injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (55)

FacilityCityRegionStatus
Moffitt Cancer Center ( Site 0021) Tampa Florida Recruiting
VA Ann Arbor Healthcare System ( Site 0019) Ann Arbor Michigan Recruiting
Washington University School of Medicine ( Site 0024) St Louis Missouri Recruiting
Valley Health Systems - Ridgewood Campus ( Site 0010) Paramus New Jersey Recruiting
New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001) Albany New York Recruiting
Cleveland Clinic - Ohio ( Site 0016) Cleveland Ohio Recruiting
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025) Corvallis Oregon Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000) Nashville Tennessee Recruiting
Texas Oncology - Central/South Texas ( Site 8002) Austin Texas Recruiting
Virginia Cancer Specialists ( Site 0003) Fairfax Virginia Recruiting
Swedish Medical Center-Swedish Cancer Institute ( Site 0023) Seattle Washington Recruiting
Hospital Italiano de Buenos Aires ( Site 0200) Ciudad Autonoma de Buenos Aires. Buenos Aires Recruiting
Instituto Alexander Fleming ( Site 0201) Ciudad Autonoma de Buenos Aires Buenos Aires Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205) Mar del Plata Buenos Aires Recruiting
Clinica Adventista Belgrano ( Site 0206) Caba. Buenos Aires F.D. Recruiting
Fundacion Estudios Clinicos ( Site 0207) Rosario Santa Fe Province Recruiting
Sanatorio Parque ( Site 0203) Rosario Santa Fe Province Recruiting
Westmead Hospital ( Site 0400) Westmead New South Wales Recruiting
Princess Alexandra Hospital ( Site 0403) Woolloongabba Queensland Recruiting
One Clinical Research ( Site 0402) Nedlands Western Australia Recruiting
Centro de Estudios Clínicos SAGA ( Site 0307) Santiago Region M. de Santiago Recruiting
FALP ( Site 0300) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 0301) Santiago Region M. de Santiago Recruiting
Bradford Hill Norte ( Site 0308) Antofagasta Chile Recruiting
Centre Georges François Leclerc ( Site 0805) Dijon Cote-d Or Recruiting
Institut de Cancérologie de l'Ouest ( Site 0801) Angers Pays de la Loire Region Recruiting
CHU GABRIEL MONTPIED ( Site 0802) Clermont-Ferrand Puy-de-Dome Recruiting
Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004) Ravenna Emilia-Romagna Recruiting
Ospedale San Raffaele-Oncologia Medica ( Site 1002) Milan Italy Recruiting
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000) Milan Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001) Roma Italy Recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101) Poznan Greater Poland Voivodeship Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100) Warsaw Masovian Voivodeship Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102) Przemyśl Podkarpackie Voivodeship Recruiting
National Cancer Center ( Site 0504) Goyang-si Kyonggi-do Recruiting
Seoul National University Bundang Hospital ( Site 0500) Seongnam-si Kyonggi-do Recruiting
Chungbuk National University Hospital-Internal medicine ( Site 0501) Cheongju-si North Chungcheong Recruiting
Asan Medical Center ( Site 0503) Seoul South Korea Recruiting
Samsung Medical Center ( Site 0502) Seoul South Korea Recruiting
ICO L Hospitalet ( Site 1311) Hospitalet Barcelona Recruiting

+ 15 more sites — see the full list on the official registry below.

On this site

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More Merck Sharp & Dohme LLC trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221474 on ClinicalTrials.gov ↗ ← All trials in the USA