A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)
NCT ID: NCT06295809
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
46 participants
INTERVENTIONAL
2024-04-18
2026-03-05
Brief Summary
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As of Amendment 04, enrollment was stopped and there will be no Phase 3 expansion.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pembrolizumab plus Intismeran autogene with SOC
Participants will receive intismeran autogene 1 mg intramuscular (IM) injection every 3 weeks (q3w) for up to 6 weeks and pembrolizumab 400 mg intravenous (IV) infusion every 6 weeks (q6w) up to 12 weeks as neoadjuvant therapy prior to surgery; followed by intismeran autogene 1 mg IM injection q3w up to 21 weeks.
Pembrolizumab
IV Infusion
Intismeran autogene
IM injection
Surgery
Local resection of cancerous lesions of the skin
Standard of Care (SOC)
Participants will receive surgical resection as per local guidelines with/without adjuvant radiation therapy (RT) at investigator's discretion.
Surgery
Local resection of cancerous lesions of the skin
Pembrolizumab with SOC
Participants will receive pembrolizumab 400 mg IV infusion q6w up to 12 weeks as neoadjuvant therapy prior to surgery.
Pembrolizumab
IV Infusion
Surgery
Local resection of cancerous lesions of the skin
Interventions
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Pembrolizumab
IV Infusion
Intismeran autogene
IM injection
Surgery
Local resection of cancerous lesions of the skin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has LA Stage II-IV (M0) cSCC without distant metastases.
* cSCC must be amenable to surgery (resectable) with curative intent.
* Has a formalin-fixed, paraffin-embedded (FFPE) tumor sample available or is able to provide one that is suitable for the Next-generation Sequencing (NGS) required for this study.
* For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving adjuvant radiation therapy (RT), and for ≥3 months after the last dose of study intervention
* Is female and not pregnant/breastfeeding and at least one of the following applies during the study : is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) at least during use of intismeran autogene: 15 days, Pembrolizumab: 120 days, Adjuvant RT, if performed: 90 days after last exposure or is a WOCBP who is abstinent from heterosexual intercourse.
* Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
* Has a life expectancy of \>3 months per investigator assessment.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization.
* Has adequate organ function.
* If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
* If there is a history of hepatitis C virus (HCV) infection, HCV viral load must be undetectable at screening
* If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria
* Has distant metastatic disease (M1), visceral and/or distant nodal
* Has received prior therapy with an anti-programmed cell death receptor 1 (anti-PD-1), anti-programmed cell death receptor ligand 1 (anti-PD-L1), or anti-programmed cell death receptor ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte associated protein 4 (CTLA-4), OX-40, CD137)
* Has received prior systemic anticancer therapy including investigational agents for cSCC before randomization
* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks of the screening blood sample (including the NGS blood sample)
* Has received prior treatment with another cancer vaccine
* Has received prior radiotherapy to the index lesion (in-field lesion). Must have recovered from all radiation-related toxicities prior to randomization and not have had radiation pneumonitis
* 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 the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
* History of chronic lymphocytic leukemia (CLL)
* History of central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has severe hypersensitivity (≥Grade 3) to either intismeran autogene or pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has HIV with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection
* Has had a myocardial infarction within 6 months of randomization
* History of allogeneic tissue/solid organ transplant
* Has not adequately recovered from major surgery or have ongoing surgical complications
18 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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USC/Norris Comprehensive Cancer Center ( Site 1112)
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian ( Site 1122)
Newport Beach, California, United States
Stanford Cancer Center ( Site 1109)
Palo Alto, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 1103)
Sacramento, California, United States
Winship Cancer Institute, Emory University ( Site 1151)
Atlanta, Georgia, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1118)
Iowa City, Iowa, United States
University of Kentucky Chandler Medical Center ( Site 1101)
Lexington, Kentucky, United States
Ochsner Clinic Foundation ( Site 1113)
New Orleans, Louisiana, United States
Massachusetts General Hospital ( Site 1162)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute ( Site 1130)
Boston, Massachusetts, United States
Washington University School of Medicine-Internal Medicine/Oncology ( Site 1100)
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1125)
Hackensack, New Jersey, United States
Atlantic Health System Morristown Medical Center ( Site 1136)
Morristown, New Jersey, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1160)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 1121)
New York, New York, United States
Providence Portland Medical Center ( Site 1102)
Portland, Oregon, United States
UPMC Hillman Cancer Center ( Site 1107)
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute- Research ( Site 1161)
Sioux Falls, South Dakota, United States
University of Virginia Health System ( Site 1115)
Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 1108)
Fairfax, Virginia, United States
University Hospital and UW Health Clinics ( Site 1119)
Madison, Wisconsin, United States
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1213)
Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 1205)
Rosario, Santa Fe Province, Argentina
Sanatorio Finochietto ( Site 1202)
Buenos Aires, , Argentina
Investigaciones Clinicas Moleculares (ICM) ( Site 1212)
CABA, , Argentina
Hospital Italiano de Córdoba ( Site 1204)
Córdoba, , Argentina
Melanoma Institute Australia-Clinical Trials Unit ( Site 3205)
Wollstonecraft, New South Wales, Australia
Sunshine Coast University Hospital-Medical Oncology ( Site 3212)
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland, Australia
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 3207)
Gold Coast, Queensland, Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 3206)
Greenslopes, Queensland, Australia
Austin Health ( Site 3209)
Heidelberg, Victoria, Australia
One Clinical Research ( Site 3211)
Nedlands, Western Australia, Australia
Cliniques universitaires Saint-Luc ( Site 1701)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Gent-Medical oncology ( Site 1702)
Ghent, Oost-Vlaanderen, Belgium
Clinica Amo - Rio Vermelho-INSTITUTO ETICA ( Site 1315)
Salvador, Estado de Bahia, Brazil
Hospital de Cancer de Londrina-Clinical Research Unit ( Site 1316)
Londrina, Paraná, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 1309)
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1300)
Porto Alegre, Rio Grande do Sul, Brazil
ANIMI - Unidade de Tratamento Oncologico ( Site 1312)
Lages, Santa Catarina, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
São José do Rio Preto, São Paulo, Brazil
IPITEC ( Site 1313)
São Paulo, São Paulo, Brazil
Jewish General Hospital ( Site 1009)
Montreal, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
Sherbrooke, Quebec, Canada
FALP-UIDO ( Site 1401)
Santiago, Region M. de Santiago, Chile
Clínica Alemana de Santiago-Gynecology and Obstetrics ( Site 1410)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 1411)
Temuco, Región de la Araucanía, Chile
CIDO SpA-Oncology ( Site 1405)
Temuco, Región de la Araucanía, Chile
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1501)
Medellín, Antioquia, Colombia
Oncologos del Occidente ( Site 1504)
Pereira, Risaralda Department, Colombia
Fundación Valle del Lili ( Site 1502)
Cali, Valle del Cauca Department, Colombia
Vseobecna fakultni nemocnice v Praze-Department of Dermatology ( Site 1800)
Prague, Praha 2, Czechia
CHU de Bordeaux Hop St ANDRE ( Site 1902)
Bordeaux, Aquitaine, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1903)
Marseille, Bouches-du-Rhone, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1904)
Dijon, Bourgogne-Franche-Comté, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 1908)
Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 1910)
Nantes, Loire-Atlantique, France
Hopital Claude Huriez - CHU de Lille ( Site 1907)
Lille, Nord, France
centre hospitalier lyon sud ( Site 1901)
Pierre-Bénite, Rhone, France
Hôpital Saint-Louis ( Site 1906)
Paris, , France
Gustave Roussy ( Site 1909)
Villejuif, Île-de-France Region, France
NCT ( Site 2002)
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen-Hautklinik ( Site 2003)
Tübingen, Baden-Wurttemberg, Germany
klinikum rechts der isar der technischen universität münchen ( Site 2009)
München, Bavaria, Germany
Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 2001)
Würzburg, Bavaria, Germany
Klinikum Dortmund Klinikzentrum Mitte ( Site 2008)
Dortmund, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 2005)
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 2007)
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Schleswig-Holstein-Dermatology ( Site 2012)
Lübeck, Schleswig-Holstein, Germany
Pécsi Tudományegyetem Klinikai Központ-Bőr-, Nemikórtani és Onkodermatológiai Klinika ( Site 2100)
Pécs, Baranya, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Közpo-Department of Dermatology and Allergol
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont-Bőrgyógyászati Klinika ( Site 2102)
Debrecen, , Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz- Onkoradiologiai Osztaly ( Site 2110)
Győr, , Hungary
Emek Medical Center ( Site 2203)
Afula, , Israel
Hadassah Medical Center ( Site 2201)
Jerusalem, , Israel
Rabin Medical Center ( Site 2202)
Petah Tikva, , Israel
Sheba Medical Center ( Site 2200)
Ramat Gan, , Israel
Instituto Tumori Giovanni Paolo II ( Site 2301)
Bari, Apulia, Italy
Ospedale San Martino-Oncologia Medica 2 ( Site 2303)
Genoa, Liguria, Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2304)
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Senese ( Site 2302)
Siena, Tuscany, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 2305)
Bergamo, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi
Napoli, , Italy
Harbour Cancer & Wellness ( Site 3300)
Auckland, , New Zealand
Oslo universitetssykehus, Radiumhospitalet ( Site 2400)
Oslo, , Norway
Centrum Medyczne HCP ( Site 2505)
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2501)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2506)
Gdansk, Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
Kielce, Świętokrzyskie Voivodeship, Poland
Spitalul Universitar de Urgență Elias ( Site 2600)
Bucharest, București, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2602)
Florești, Cluj, Romania
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2601)
Craiova, Dolj, Romania
Sigmedical Services SRL ( Site 2603)
Suceava, , Romania
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 2804)
Badalona, Barcelona, Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
Barcelona, Catalonia, Spain
Centro Oncologico de Galicia ( Site 2806)
A Coruña, Galicia, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2801)
Madrid, Madrid, Comunidad de, Spain
H.R.U Malaga - Hospital General ( Site 2805)
Málaga, Malaga, Spain
Hospital General Universitario de Valencia-oncology service ( Site 2802)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2803)
Barcelona, , Spain
Clinica Universidad de Navarra-Medical Oncology ( Site 2807)
Madrid, , Spain
Addenbrooke's Hospital-Cambridge Cancer Trials Centre ( Site 3103)
Cambridge, Cambridgeshire, United Kingdom
Derriford Hospital-Oncology ( Site 3104)
Plymouth, Devon, United Kingdom
Castle Hill Hospital ( Site 3102)
Cottingham, East Riding Of Yorkshire, United Kingdom
Singleton Hospital-South West Wales Cancer Institute ( Site 3100)
Swansea, , United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2023-505712-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1292-3589
Identifier Type: REGISTRY
Identifier Source: secondary_id
V940
Identifier Type: OTHER
Identifier Source: secondary_id
V940-007
Identifier Type: -
Identifier Source: org_study_id
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