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Carcinoma, Squamous CellPhase 2/3INTerpath-007NCT06295809

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

A Phase 2/3 study testing Pembrolizumab, Intismeran autogene and Surgery in people with Carcinoma, Squamous Cell and Skin Neoplasms, run by Merck Sharp & Dohme LLC at 106 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Squamous Cell, Skin Neoplasms
What is being tested?
Pembrolizumab, Intismeran autogene and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
106 sitesin 20 countries
Study dates
18 Apr 2024to 5 Mar 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

106 sites in 20 countries.

106 sites in 20 countries

United States21 sites

  • Winship Cancer Institute, Emory University ( Site 1151)

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital ( Site 1162)

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute ( Site 1130)

    Boston, Massachusetts, 02215

  • University of Virginia Health System ( Site 1115)

    Charlottesville, Virginia, 22908

  • Inova Schar Cancer Institute ( Site 1108)

    Fairfax, Virginia, 22031

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1125)

    Hackensack, New Jersey, 07601

  • University of Iowa-Holden Comprehensive Cancer Center ( Site 1118)

    Iowa City, Iowa, 52242

  • University of Kentucky Chandler Medical Center ( Site 1101)

    Lexington, Kentucky, 40536

  • USC/Norris Comprehensive Cancer Center ( Site 1112)

    Los Angeles, California, 90033

  • University Hospital and UW Health Clinics ( Site 1119)

    Madison, Wisconsin, 53792

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 1160)

    Mineola, New York, 11501

  • Atlantic Health System Morristown Medical Center ( Site 1136)

    Morristown, New Jersey, 07960

  • Ochsner Clinic Foundation ( Site 1113)

    New Orleans, Louisiana, 70121

  • Laura and Isaac Perlmutter Cancer Center ( Site 1121)

    New York, New York, 10016

  • Hoag Memorial Hospital Presbyterian ( Site 1122)

    Newport Beach, California, 92663

  • Stanford Cancer Center ( Site 1109)

    Palo Alto, California, 94304

  • UPMC Hillman Cancer Center ( Site 1107)

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center ( Site 1102)

    Portland, Oregon, 97213

  • University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 1103)

    Sacramento, California, 95817

  • Avera Cancer Institute- Research ( Site 1161)

    Sioux Falls, South Dakota, 57105

  • Washington University School of Medicine-Internal Medicine/Oncology ( Site 1100)

    St Louis, Missouri, 63110

Other trials in United States

France9 sites

  • CHU de Bordeaux Hop St ANDRE ( Site 1902)

    Bordeaux, Aquitaine, 33075

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1904)

    Dijon, Bourgogne-Franche-Comté, 21000

  • Hopital Claude Huriez - CHU de Lille ( Site 1907)

    Lille, Nord, 59037

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 1903)

    Marseille, Bouches-du-Rhone, 13005

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Onco-Dermatology ( Site 1910)

    Nantes, Loire-Atlantique, 44093

  • Hôpital Saint-Louis ( Site 1906)

    Paris, 75475

  • centre hospitalier lyon sud ( Site 1901)

    Pierre-Bénite, Rhone, 69310

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 1908)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 1909)

    Villejuif, Île-de-France Region, 94800

Other trials in France

Germany8 sites

  • Klinikum Dortmund Klinikzentrum Mitte ( Site 2008)

    Dortmund, North Rhine-Westphalia, 44137

  • Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 2005)

    Essen, North Rhine-Westphalia, 45147

  • NCT ( Site 2002)

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum Schleswig-Holstein-Dermatology ( Site 2012)

    Lübeck, Schleswig-Holstein, 23538

  • Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 2007)

    Mainz, Rhineland-Palatinate, 55131

  • klinikum rechts der isar der technischen universität münchen ( Site 2009)

    München, Bavaria, 81675

  • Universitaetsklinikum Tuebingen-Hautklinik ( Site 2003)

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 2001)

    Würzburg, Bavaria, 97080

Other trials in Germany

Spain8 sites

  • Centro Oncologico de Galicia ( Site 2806)

    A Coruña, Galicia, 15009

  • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 2804)

    Badalona, Barcelona, 08916

  • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

    Barcelona, Catalonia, 08036

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2803)

    Barcelona, 08035

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2801)

    Madrid, Madrid, Comunidad de, 28034

  • Clinica Universidad de Navarra-Medical Oncology ( Site 2807)

    Madrid, 28027

  • H.R.U Malaga - Hospital General ( Site 2805)

    Málaga, Malaga, 29010

  • Hospital General Universitario de Valencia-oncology service ( Site 2802)

    Valencia, Valenciana, Comunitat, 46014

Other trials in Spain

Australia7 sites

  • Sunshine Coast University Hospital-Medical Oncology ( Site 3212)

    Birtinya, Queensland, 4575

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

    Brisbane, Queensland, 4029

  • Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 3207)

    Gold Coast, Queensland, 4215

  • Gallipoli Medical Research Ltd-GMRF CTU ( Site 3206)

    Greenslopes, Queensland, 4120

  • Austin Health ( Site 3209)

    Heidelberg, Victoria, 3084

  • One Clinical Research ( Site 3211)

    Nedlands, Western Australia, 6009

  • Melanoma Institute Australia-Clinical Trials Unit ( Site 3205)

    Wollstonecraft, New South Wales, 2065

Other trials in Australia

Brazil7 sites

  • ANIMI - Unidade de Tratamento Oncologico ( Site 1312)

    Lages, Santa Catarina, 88501001

  • Hospital de Cancer de Londrina-Clinical Research Unit ( Site 1316)

    Londrina, Paraná, 86015-520

  • Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 1309)

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1300)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Clinica Amo - Rio Vermelho-INSTITUTO ETICA ( Site 1315)

    Salvador, Estado de Bahia, 41950-640

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site

    São José do Rio Preto, São Paulo, 15090-000

  • IPITEC ( Site 1313)

    São Paulo, São Paulo, 01223-001

Other trials in Brazil

Italy6 sites

  • Instituto Tumori Giovanni Paolo II ( Site 2301)

    Bari, Apulia, 70124

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 2305)

    Bergamo, 24127

  • Ospedale San Martino-Oncologia Medica 2 ( Site 2303)

    Genoa, Liguria, 16132

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapi

    Naples, 80131

  • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2304)

    Rozzano, Milano, 20089

  • Azienda Ospedaliero Universitaria Senese ( Site 2302)

    Siena, Tuscany, 53100

Other trials in Italy

Argentina5 sites

  • Sanatorio Finochietto ( Site 1202)

    Buenos Aires, C1187AAN

  • Investigaciones Clinicas Moleculares (ICM) ( Site 1212)

    CABA, C1425BGH

  • Hospital Italiano de Córdoba ( Site 1204)

    Córdoba, X5004BAL

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1213)

    Mar del Plata, Buenos Aires, 7600

  • Fundacion Estudios Clinicos-Oncology ( Site 1205)

    Rosario, Santa Fe Province, S2000DEJ

Other trials in Argentina

Poland5 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2501)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2506)

    Gdansk, Pomeranian Voivodeship, 80-952

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Centrum Medyczne HCP ( Site 2505)

    Poznan, Greater Poland Voivodeship, 61-485

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Chile4 sites

  • FALP-UIDO ( Site 1401)

    Santiago, Region M. de Santiago, 7500921

  • Clínica Alemana de Santiago-Gynecology and Obstetrics ( Site 1410)

    Santiago, Region M. de Santiago, 7650568

  • James Lind Centro de Investigacion del Cancer ( Site 1411)

    Temuco, Araucania, 4800827

  • CIDO SpA-Oncology ( Site 1405)

    Temuco, Araucania, 4810218

Other trials in Chile

Hungary4 sites

  • Debreceni Egyetem Klinikai Kozpont-Bőrgyógyászati Klinika ( Site 2102)

    Debrecen, 4032

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz- Onkoradiologiai Osztaly ( Site 2110)

    Győr, 9024

  • Pécsi Tudományegyetem Klinikai Központ-Bőr-, Nemikórtani és Onkodermatológiai Klinika ( Site 2100)

    Pécs, Baranya, 7632

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Közpo-Department of Dermatology and Allergol

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Israel4 sites

  • Emek Medical Center ( Site 2203)

    Afula, 1834111

  • Hadassah Medical Center ( Site 2201)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 2202)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 2200)

    Ramat Gan, 5265601

Other trials in Israel

Romania4 sites

  • Spitalul Universitar de Urgență Elias ( Site 2600)

    Bucharest, Bucharest, 011461

  • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2601)

    Craiova, Dolj, 200542

  • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2602)

    Florești, Cluj, 407280

  • Sigmedical Services SRL ( Site 2603)

    Suceava, 720214

Other trials in Romania

United Kingdom4 sites

  • Addenbrooke's Hospital-Cambridge Cancer Trials Centre ( Site 3103)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Castle Hill Hospital ( Site 3102)

    Cottingham, East Riding Of Yorkshire, HU16 5JQ

  • Derriford Hospital-Oncology ( Site 3104)

    Plymouth, Devon, Pl6 8DH

  • Singleton Hospital-South West Wales Cancer Institute ( Site 3100)

    Swansea, SA2 8QA

Other trials in United Kingdom

Colombia3 sites

  • Fundación Valle del Lili ( Site 1502)

    Cali, Valle del Cauca Department, 760032

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1501)

    Medellín, Antioquia, 050030

  • Oncologos del Occidente ( Site 1504)

    Pereira, Risaralda Department, 660001

Other trials in Colombia

Belgium2 sites

  • Cliniques universitaires Saint-Luc ( Site 1701)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • UZ Gent-Medical oncology ( Site 1702)

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

Canada2 sites

  • Jewish General Hospital ( Site 1009)

    Montreal, Quebec, H3T 1E2

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer

    Sherbrooke, Quebec, J1H 5H4

Other trials in Canada

Czechia1 site

  • Vseobecna fakultni nemocnice v Praze-Department of Dermatology ( Site 1800)

    Prague, Praha 2, 12808

Other trials in Czechia

New Zealand1 site

  • Harbour Cancer & Wellness ( Site 3300)

    Auckland, 1023

Other trials in New Zealand

Norway1 site

  • Oslo universitetssykehus, Radiumhospitalet ( Site 2400)

    Oslo, 0379

Other trials in Norway

About this study

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)

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.

Being tested
Pembrolizumab, Intismeran autogene, Surgery
Keywords
pembrolizumab
Medical subject headings
Carcinoma, Squamous Cell, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    IV Infusion

  • Intismeran autogeneBiological

    Also called mRNA-4157, V940

    IM injection

  • SurgeryProcedure or surgery

    Local resection of cancerous lesions of the skin

Study groups in NCT06295809
Study groupRoleWhat they receive
Pembrolizumab plus Intismeran autogene with SOCExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Biological: Intismeran autogene; Procedure: Surgery
Standard of Care (SOC)Active comparatorParticipants will receive surgical resection as per local guidelines with/without adjuvant radiation therapy (RT) at investigator's discretion.
Receives: Procedure: Surgery
Pembrolizumab with SOCExperimentalParticipants will receive pembrolizumab 400 mg IV infusion q6w up to 12 weeks as neoadjuvant therapy prior to surgery.
Receives: Biological: Pembrolizumab; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to ~22 months

Secondary outcomes (8)

  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.

    Measured: Up to ~22 months

  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.

    Measured: Up to ~22 months

  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.

    Measured: Up to ~22 months

  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.

    Measured: Up to ~22 months

  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.

    Measured: Up to ~22 months

  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.

    Measured: Up to ~22 months

  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.

    Measured: Up to ~22 months

  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.

    Measured: Up to ~22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start18 Apr 2024
  3. Primary completion5 Mar 2026
  4. Study completion5 Mar 2026

Why it stopped: Business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295809
Sponsor's protocol ID
V940-007
Other IDs
2023-505712-37-00, U1111-1292-3589, V940, 2023
Acronym
INTerpath-007
Status last verified
Apr 2026
First submitted
29 Feb 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Pembrolizumab, Intismeran autogene and Surgery in people with Carcinoma, Squamous Cell and Skin Neoplasms, run by Merck Sharp & Dohme LLC at 106 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, France, Germany, Spain, Australia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (EFS) (time frame: Up to ~22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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