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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Squamous Cell; Skin Neoplasms
• Intervention / Treatment: Biological: Pembrolizumab; Procedure: Surgery; Biological: Intismeran autogene

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1187AAN
    • Sanatorio Finochietto ( Site 1202)
  • CABA, Argentina, C1425BGH
    • Investigaciones Clinicas Moleculares (ICM) ( Site 1212)
  • Córdoba, Argentina, X5004BAL
    • Hospital Italiano de Córdoba ( Site 1204)
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1213)
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000DEJ
      • Fundacion Estudios Clinicos-Oncology ( Site 1205)
• Australia
  • New South Wales
    • Wollstonecraft, New South Wales, Australia, 2065
      • Melanoma Institute Australia-Clinical Trials Unit ( Site 3205)
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hospital-Medical Oncology ( Site 3212)
    • Brisbane, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
    • Gold Coast, Queensland, Australia, 4215
      • Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 3207)
    • Greenslopes, Queensland, Australia, 4120
      • Gallipoli Medical Research Ltd-GMRF CTU ( Site 3206)
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health ( Site 3209)
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • One Clinical Research ( Site 3211)
• Belgium
  • Bruxelles-Capitale, Region de
    • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
      • Cliniques universitaires Saint-Luc ( Site 1701)
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent-Medical oncology ( Site 1702)
• Brazil
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41950-640
      • Clinica Amo - Rio Vermelho-INSTITUTO ETICA ( Site 1315)
  • Paraná
    • Londrina, Paraná, Brazil, 86015-520
      • Hospital de Cancer de Londrina-Clinical Research Unit ( Site 1316)
  • Rio Grande do Sul
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
      • Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 1309)
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1300)
  • Santa Catarina
    • Lages, Santa Catarina, Brazil, 88501001
      • ANIMI - Unidade de Tratamento Oncologico ( Site 1312)
  • São Paulo
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
    • São Paulo, São Paulo, Brazil, 01223-001
      • IPITEC ( Site 1313)
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital ( Site 1009)
    • Sherbrooke, Quebec, Canada, J1H 5H4
      • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • James Lind Centro de Investigacion del Cancer ( Site 1411)
    • Temuco, Araucania, Chile, 4810218
      • CIDO SpA-Oncology ( Site 1405)
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7500921
      • FALP-UIDO ( Site 1401)
    • Santiago, Region M. de Santiago, Chile, 7650568
      • Clínica Alemana de Santiago-Gynecology and Obstetrics ( Site 1410)
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050030
      • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1501)
  • Risaralda Department
    • Pereira, Risaralda Department, Colombia, 660001
      • Oncologos del Occidente ( Site 1504)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760032
      • Fundación Valle del Lili ( Site 1502)
• Czechia
  • Praha 2
    • Prague, Praha 2, Czechia, 12808
      • Vseobecna fakultni nemocnice v Praze-Department of Dermatology ( Site 1800)
• France
  • Paris, France, 75475
    • Hôpital Saint-Louis ( Site 1906)
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33075
      • CHU de Bordeaux Hop St ANDRE ( Site 1902)
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13005
      • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1903)
  • Bourgogne-Franche-Comté
    • Dijon, Bourgogne-Franche-Comté, France, 21000
      • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1904)
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 1908)
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 1910)
  • Nord
    • Lille, Nord, France, 59037
      • Hopital Claude Huriez - CHU de Lille ( Site 1907)
  • Rhone
    • Pierre-Bénite, Rhone, France, 69310
      • centre hospitalier lyon sud ( Site 1901)
  • Île-de-France Region
    • Villejuif, Île-de-France Region, France, 94800
      • Gustave Roussy ( Site 1909)
• Germany
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • NCT ( Site 2002)
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen-Hautklinik ( Site 2003)
  • Bavaria
    • München, Bavaria, Germany, 81675
      • klinikum rechts der isar der technischen universität münchen ( Site 2009)
    • Würzburg, Bavaria, Germany, 97080
      • Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 2001)
  • North Rhine-Westphalia
    • Dortmund, North Rhine-Westphalia, Germany, 44137
      • Klinikum Dortmund Klinikzentrum Mitte ( Site 2008)
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 2005)
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 2007)
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Universitätsklinikum Schleswig-Holstein-Dermatology ( Site 2012)
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont-Bőrgyógyászati Klinika ( Site 2102)
  • Győr, Hungary, 9024
    • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz- Onkoradiologiai Osztaly ( Site 2110)
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Pécsi Tudományegyetem Klinikai Központ-Bőr-, Nemikórtani és Onkodermatológiai Klinika ( Site 2100)
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6720
      • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Közpo-Department of Dermatology and Allergol
• Israel
  • Afula, Israel, 1834111
    • Emek Medical Center ( Site 2203)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center ( Site 2201)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 2202)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 2200)
• Italy
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 2305)
  • Naples, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Instituto Tumori Giovanni Paolo II ( Site 2301)
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Ospedale San Martino-Oncologia Medica 2 ( Site 2303)
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2304)
  • Tuscany
    • Siena, Tuscany, Italy, 53100
      • Azienda Ospedaliero Universitaria Senese ( Site 2302)
• New Zealand
  • Auckland, New Zealand, 1023
    • Harbour Cancer & Wellness ( Site 3300)
• Norway
  • Oslo, Norway, 0379
    • Oslo universitetssykehus, Radiumhospitalet ( Site 2400)
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-485
      • Centrum Medyczne HCP ( Site 2505)
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2501)
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-952
      • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2506)
  • Świętokrzyskie Voivodeship
    • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
      • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
• Romania
  • Suceava, Romania, 720214
    • Sigmedical Services SRL ( Site 2603)
  • Bucharest
    • Bucharest, Bucharest, Romania, 011461
      • Spitalul Universitar de Urgență Elias ( Site 2600)
  • Cluj
    • Florești, Cluj, Romania, 407280
      • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2602)
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2601)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2803)
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra-Medical Oncology ( Site 2807)
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 2804)
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
  • Galicia
    • A Coruña, Galicia, Spain, 15009
      • Centro Oncologico de Galicia ( Site 2806)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2801)
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • H.R.U Malaga - Hospital General ( Site 2805)
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46014
      • Hospital General Universitario de Valencia-oncology service ( Site 2802)
• United Kingdom
  • Swansea, United Kingdom, SA2 8QA
    • Singleton Hospital-South West Wales Cancer Institute ( Site 3100)
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital-Cambridge Cancer Trials Centre ( Site 3103)
  • Devon
    • Plymouth, Devon, United Kingdom, Pl6 8DH
      • Derriford Hospital-Oncology ( Site 3104)
  • East Riding Of Yorkshire
    • Cottingham, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
      • Castle Hill Hospital ( Site 3102)
• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center ( Site 1112)
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian ( Site 1122)
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Center ( Site 1109)
    • Sacramento, California, United States, 95817
      • University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 1103)
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University ( Site 1151)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa-Holden Comprehensive Cancer Center ( Site 1118)
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center ( Site 1101)
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation ( Site 1113)
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital ( Site 1162)
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute ( Site 1130)
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine-Internal Medicine/Oncology ( Site 1100)
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1125)
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System Morristown Medical Center ( Site 1136)
  • New York
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1160)
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center ( Site 1121)
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center ( Site 1102)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center ( Site 1107)
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute- Research ( Site 1161)
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System ( Site 1115)
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute ( Site 1108)
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University Hospital and UW Health Clinics ( Site 1119)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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
Experimental: 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; Other Names: MK-3475; Keytruda®; Procedure: Surgery; Local resection of cancerous lesions of the skin; Biological: Intismeran autogene; IM injection; Other Names: mRNA-4157; V940
Experimental: 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; Other Names: MK-3475; Keytruda®; Procedure: Surgery; Local resection of cancerous lesions of the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to ~22 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to ~22 months
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.	Up to ~22 months
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.	Up to ~22 months
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.	Up to ~22 months
Disease-specific survival (DSS)	DSS is defined as time from randomization to death due to progression of cancer under study. DSS will be presented.	Up to ~22 months
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.	Up to ~22 months
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.	Up to ~22 months
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.	Up to ~22 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: ModernaTX, Inc.
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Actual): March 5, 2026
• Study Completion (Actual): March 5, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pembrolizumab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Carcinoma; Neoplasms, Squamous Cell; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Skin Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; pembrolizumab; Surgical Procedures, Operative
• Other Study ID Numbers: V940-007; U1111-1292-3589 (Registry Identifier: UTN); V940 (Other Identifier: MSD); 2023-505712-37-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No