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TERMINATED

NCT06295809

PHASE2/PHASE3

A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a two-part (Phase 2/Phase 3) study of intismeran autogene, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms intismeran autogene plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of intismeran autogene in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that intismeran autogene plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to intismeran autogene plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints. As of Amendment 04, enrollment was stopped and there will be no Phase 3 expansion.

Official title: A Phase 2/3, Adaptive, Randomized, Open-label, Clinical Study to Evaluate Neoadjuvant and Adjuvant Intismeran Autogene (mRNA-4157) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care, and Pembrolizumab Monotherapy in Participants With Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (INTerpath-007)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-18

Completion Date

2026-03-05

Last Updated

2026-05-08

Healthy Volunteers

Conditions

Carcinoma, Squamous Cell Skin Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

IV Infusion

BIOLOGICAL

Intismeran autogene

IM injection

PROCEDURE

Surgery

Local resection of cancerous lesions of the skin

Inclusion Criteria: * Has a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted). * 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 any other histologic type of skin cancer other than invasive cSCC as well as mixed histology, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), or melanoma * 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

Locations (106)

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

James Lind Centro de Investigacion del Cancer ( Site 1411)

Temuco, Araucania, Chile

CIDO SpA-Oncology ( Site 1405)

Temuco, Araucania, Chile

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

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

Naples, 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, Bucharest, 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