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

Recruitment Status
TERMINATED
(See Contacts and Locations)Verified March 2026 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT06295809
Other Study ID Numbers:
V940-007
First Submitted
February 28, 2024
First Posted
March 5, 2024
Last Update Posted
May 7, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Carcinoma, Squamous CellSkin Neoplasms
Biological: PembrolizumabProcedure: SurgeryBiological: Pembrolizumab

Study Design

Study TypeInterventional
Actual Enrollment46 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleA 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)
Study Start DateApril 17, 2024
Actual Primary Completion DateMarch 4, 2026
Actual Study Completion DateMarch 4, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Biological: Pembrolizumab
IV Infusion
Standard of Care (SOC)
Participants will receive surgical resection as per local guidelines with/without adjuvant radiation therapy (RT) at investigator's discretion.
Procedure: 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.
Biological: Pembrolizumab
IV Infusion

Outcome Measures

Primary Outcome Measures
  1. Event Free Survival (EFS)
    EFS is defined as the time from randomization to any of the following events as assessed by the investigator: progression of disease that precludes surgery, or inability to undergo R0 or R1 surgical resection; disease recurrence (local, regional, or distant); new primary high-risk cSCC; death due to any cause. EFS will be presented.
Secondary Outcome Measures
  1. Overall response rate (ORR)
    ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR). ORR will be presented.
  2. Freedom from surgery (FFS) rate
    FFS rate is defined as the proportion of participants with clinical CR with no residual tumor on clinical exam and imaging with the confirmation of negative biopsy. FFS rate will be presented.
  3. Pathologic complete response (pCR) rate
    pCR rate is defined as the proportion of participants who have complete absence of viable tumor in the surgical resection specimen. The pCR rate will be presented.
  4. Major pathologic response (mPR) rate
    mPR rate is defined as the proportion of participants who have ≤10% of viable tumor cells in the surgical resection specimen. The mPR rate will be presented.
  5. Disease-specific survival (DSS)
    DSS is defined as time from randomization to death due to progression of cancer under study. DSS will be presented.
  6. Overall Survival (OS)
    OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
  7. Percentage of participants who experience an adverse event (AE)
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
  8. Percentage of participants who discontinue study intervention due to AEs
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue intervention due to an AE will be reported.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
USC/Norris Comprehensive Cancer Center ( Site 1112) | Los Angeles California, United States, 90033Hoag Memorial Hospital Presbyterian ( Site 1122) | Newport Beach California, United States, 92663Stanford Cancer Center ( Site 1109) | Palo Alto California, United States, 94304University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 1103) | Sacramento California, United States, 95817Winship Cancer Institute, Emory University ( Site 1151) | Atlanta Georgia, United States, 30322University of Iowa-Holden Comprehensive Cancer Center ( Site 1118) | Iowa City Iowa, United States, 52242University of Kentucky Chandler Medical Center ( Site 1101) | Lexington Kentucky, United States, 40536Ochsner Clinic Foundation ( Site 1113) | New Orleans Louisiana, United States, 70121Massachusetts General Hospital ( Site 1162) | Boston Massachusetts, United States, 02114Dana-Farber Cancer Institute ( Site 1130) | Boston Massachusetts, United States, 02215Washington University School of Medicine-Internal Medicine/Oncology ( Site 1100) | St Louis Missouri, United States, 63110John Theurer Cancer Center at Hackensack University Medical Center ( Site 1125) | Hackensack New Jersey, United States, 07601Atlantic Health System Morristown Medical Center ( Site 1136) | Morristown New Jersey, United States, 07960Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1160) | Mineola New York, United States, 11501Laura and Isaac Perlmutter Cancer Center ( Site 1121) | New York New York, United States, 10016Providence Portland Medical Center ( Site 1102) | Portland Oregon, United States, 97213UPMC Hillman Cancer Center ( Site 1107) | Pittsburgh Pennsylvania, United States, 15232Avera Cancer Institute- Research ( Site 1161) | Sioux Falls South Dakota, United States, 57105University of Virginia Health System ( Site 1115) | Charlottesville Virginia, United States, 22908Inova Schar Cancer Institute ( Site 1108) | Fairfax Virginia, United States, 22031University Hospital and UW Health Clinics ( Site 1119) | Madison Wisconsin, United States, 53792Instituto de Investigaciones Clínicas Mar del Plata ( Site 1213) | Mar del Plata Buenos Aires, Argentina, 7600Fundacion Estudios Clinicos-Oncology ( Site 1205) | Rosario Santa Fe Province, Argentina, S2000DEJSanatorio Finochietto ( Site 1202) | Buenos Aires , Argentina, C1187AANInvestigaciones Clinicas Moleculares (ICM) ( Site 1212) | CABA , Argentina, C1425BGHHospital Italiano de Córdoba ( Site 1204) | Córdoba , Argentina, X5004BALMelanoma Institute Australia-Clinical Trials Unit ( Site 3205) | Wollstonecraft New South Wales, Australia, 2065Sunshine Coast University Hospital-Medical Oncology ( Site 3212) | Birtinya Queensland, Australia, 4575Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si | Brisbane Queensland, Australia, 4029Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 3207) | Gold Coast Queensland, Australia, 4215Gallipoli Medical Research Ltd-GMRF CTU ( Site 3206) | Greenslopes Queensland, Australia, 4120Austin Health ( Site 3209) | Heidelberg Victoria, Australia, 3084One Clinical Research ( Site 3211) | Nedlands Western Australia, Australia, 6009Cliniques universitaires Saint-Luc ( Site 1701) | Brussels Bruxelles-Capitale, Region de, Belgium, 1200UZ Gent-Medical oncology ( Site 1702) | Ghent Oost-Vlaanderen, Belgium, 9000Clinica Amo - Rio Vermelho-INSTITUTO ETICA ( Site 1315) | Salvador Estado de Bahia, Brazil, 41950-640Hospital de Cancer de Londrina-Clinical Research Unit ( Site 1316) | Londrina Paraná, Brazil, 86015-520Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 1309) | Passo Fundo Rio Grande do Sul, Brazil, 99010-080Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1300) | Porto Alegre Rio Grande do Sul, Brazil, 91350-200ANIMI - Unidade de Tratamento Oncologico ( Site 1312) | Lages Santa Catarina, Brazil, 88501001Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site | São José do Rio Preto São Paulo, Brazil, 15090-000IPITEC ( Site 1313) | São Paulo São Paulo, Brazil, 01223-001Jewish General Hospital ( Site 1009) | Montreal Quebec, Canada, H3T 1E2Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer | Sherbrooke Quebec, Canada, J1H 5H4James Lind Centro de Investigacion del Cancer ( Site 1411) | Temuco Araucania, Chile, 4800827CIDO SpA-Oncology ( Site 1405) | Temuco Araucania, Chile, 4810218FALP-UIDO ( Site 1401) | Santiago Region M. de Santiago, Chile, 7500921Clínica Alemana de Santiago-Gynecology and Obstetrics ( Site 1410) | Santiago Region M. de Santiago, Chile, 7650568Fundacion Colombiana de Cancerología Clinica Vida ( Site 1501) | Medellín Antioquia, Colombia, 050030Oncologos del Occidente ( Site 1504) | Pereira Risaralda Department, Colombia, 660001Fundación Valle del Lili ( Site 1502) | Cali Valle del Cauca Department, Colombia, 760032Vseobecna fakultni nemocnice v Praze-Department of Dermatology ( Site 1800) | Prague Praha 2, Czechia, 12808CHU de Bordeaux Hop St ANDRE ( Site 1902) | Bordeaux Aquitaine, France, 33075Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1903) | Marseille Bouches-du-Rhone, France, 13005Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1904) | Dijon Bourgogne-Franche-Comté, France, 21000Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 1908) | Toulouse Haute-Garonne, France, 31059Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 1910) | Nantes Loire-Atlantique, France, 44093Hopital Claude Huriez - CHU de Lille ( Site 1907) | Lille Nord, France, 59037centre hospitalier lyon sud ( Site 1901) | Pierre-Bénite Rhone, France, 69310Hôpital Saint-Louis ( Site 1906) | Paris , France, 75475Gustave Roussy ( Site 1909) | Villejuif Île-de-France Region, France, 94800NCT ( Site 2002) | Heidelberg Baden-Wurttemberg, Germany, 69120Universitaetsklinikum Tuebingen-Hautklinik ( Site 2003) | Tübingen Baden-Wurttemberg, Germany, 72076klinikum rechts der isar der technischen universität münchen ( Site 2009) | München Bavaria, Germany, 81675Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 2001) | Würzburg Bavaria, Germany, 97080Klinikum Dortmund Klinikzentrum Mitte ( Site 2008) | Dortmund North Rhine-Westphalia, Germany, 44137Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 2005) | Essen North Rhine-Westphalia, Germany, 45147Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 2007) | Mainz Rhineland-Palatinate, Germany, 55131Universitätsklinikum Schleswig-Holstein-Dermatology ( Site 2012) | Lübeck Schleswig-Holstein, Germany, 23538Pécsi Tudományegyetem Klinikai Központ-Bőr-, Nemikórtani és Onkodermatológiai Klinika ( Site 2100) | Pécs Baranya, Hungary, 7632Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Közpo-Department of Dermatology and Allergol | Szeged Csongrád megye, Hungary, 6720Debreceni Egyetem Klinikai Kozpont-Bőrgyógyászati Klinika ( Site 2102) | Debrecen , Hungary, 4032Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz- Onkoradiologiai Osztaly ( Site 2110) | Győr , Hungary, 9024Emek Medical Center ( Site 2203) | Afula , Israel, 1834111Hadassah Medical Center ( Site 2201) | Jerusalem , Israel, 9112001Rabin Medical Center ( Site 2202) | Petah Tikva , Israel, 4941492Sheba Medical Center ( Site 2200) | Ramat Gan , Israel, 5265601Instituto Tumori Giovanni Paolo II ( Site 2301) | Bari Apulia, Italy, 70124Ospedale San Martino-Oncologia Medica 2 ( Site 2303) | Genoa Liguria, Italy, 16132Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2304) | Rozzano Milano, Italy, 20089Azienda Ospedaliero Universitaria Senese ( Site 2302) | Siena Tuscany, Italy, 53100Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 2305) | Bergamo , Italy, 24127Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi | Naples , Italy, 80131Harbour Cancer & Wellness ( Site 3300) | Auckland , New Zealand, 1023Oslo universitetssykehus, Radiumhospitalet ( Site 2400) | Oslo , Norway, 0379Centrum Medyczne HCP ( Site 2505) | Poznan Greater Poland Voivodeship, Poland, 61-485Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2501) | Bydgoszcz Kuyavian-Pomeranian Voivodeship, Poland, 85-796Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( | Warsaw Masovian Voivodeship, Poland, 02-781Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2506) | Gdansk Pomeranian Voivodeship, Poland, 80-952Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch | Kielce Świętokrzyskie Voivodeship, Poland, 25-734Spitalul Universitar de Urgență Elias ( Site 2600) | Bucharest Bucharest, Romania, 011461SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2602) | Florești Cluj, Romania, 407280Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2601) | Craiova Dolj, Romania, 200542Sigmedical Services SRL ( Site 2603) | Suceava , Romania, 720214Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 2804) | Badalona Barcelona, Spain, 08916HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit | Barcelona Catalonia, Spain, 08036Centro Oncologico de Galicia ( Site 2806) | A Coruña Galicia, Spain, 15009Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2801) | Madrid Madrid, Comunidad de, Spain, 28034H.R.U Malaga - Hospital General ( Site 2805) | Málaga Malaga, Spain, 29010Hospital General Universitario de Valencia-oncology service ( Site 2802) | Valencia Valenciana, Comunitat, Spain, 46014Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2803) | Barcelona , Spain, 08035Clinica Universidad de Navarra-Medical Oncology ( Site 2807) | Madrid , Spain, 28027Addenbrooke's Hospital-Cambridge Cancer Trials Centre ( Site 3103) | Cambridge Cambridgeshire, United Kingdom, CB2 2QQDerriford Hospital-Oncology ( Site 3104) | Plymouth Devon, United Kingdom, Pl6 8DHCastle Hill Hospital ( Site 3102) | Cottingham East Riding Of Yorkshire, United Kingdom, HU16 5JQSingleton Hospital-South West Wales Cancer Institute ( Site 3100) | Swansea , United Kingdom, SA2 8QA
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC