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Personalized mRNA cancer vaccine trial halted midway

NCT ID NCT06295809

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a personalized mRNA vaccine (mRNA-4157) combined with the immunotherapy drug pembrolizumab for people with advanced but removable skin cancer (cutaneous squamous cell carcinoma). The goal was to see if the combination could prevent the cancer from coming back better than standard treatment alone. The trial was stopped early after enrolling only 46 participants, so the planned larger phase 3 expansion did not happen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

46 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

skin neoplasm skin squamous cell carcinoma squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, squamous cell Skin neoplasms

Contacts and locations

Locations

  • ANIMI - Unidade de Tratamento Oncologico ( Site 1312)

    Lages, Santa Catarina, 88501001, Brazil

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

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

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

    Marseille, Bouches-du-Rhone, 13005, France

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

    Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

  • Atlantic Health System Morristown Medical Center ( Site 1136)

    Morristown, New Jersey, 07960, United States

  • Austin Health ( Site 3209)

    Heidelberg, Victoria, 3084, Australia

  • Avera Cancer Institute- Research ( Site 1161)

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliero Universitaria Senese ( Site 2302)

    Siena, Tuscany, 53100, Italy

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

    Bergamo, 24127, Italy

  • CHU de Bordeaux Hop St ANDRE ( Site 1902)

    Bordeaux, Aquitaine, 33075, France

  • CIDO SpA-Oncology ( Site 1405)

    Temuco, Araucania, 4810218, Chile

  • Castle Hill Hospital ( Site 3102)

    Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

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

    Dijon, Bourgogne-Franche-Comté, 21000, France

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

    Nantes, Loire-Atlantique, 44093, France

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

    Sherbrooke, Quebec, J1H 5H4, Canada

  • Centro Oncologico de Galicia ( Site 2806)

    A Coruña, Galicia, 15009, Spain

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

    Craiova, Dolj, 200542, Romania

  • Centrum Medyczne HCP ( Site 2505)

    Poznan, Greater Poland Voivodeship, 61-485, Poland

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

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

    Salvador, Estado de Bahia, 41950-640, Brazil

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

    Madrid, 28027, Spain

  • Cliniques universitaires Saint-Luc ( Site 1701)

    Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

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

    Santiago, Region M. de Santiago, 7650568, Chile

  • Dana-Farber Cancer Institute ( Site 1130)

    Boston, Massachusetts, 02215, United States

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

    Debrecen, 4032, Hungary

  • Derriford Hospital-Oncology ( Site 3104)

    Plymouth, Devon, Pl6 8DH, United Kingdom

  • Emek Medical Center ( Site 2203)

    Afula, 1834111, Israel

  • FALP-UIDO ( Site 1401)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 1501)

    Medellín, Antioquia, 050030, Colombia

  • Fundacion Estudios Clinicos-Oncology ( Site 1205)

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Fundación Valle del Lili ( Site 1502)

    Cali, Valle del Cauca Department, 760032, Colombia

  • 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, Brazil

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

    Greenslopes, Queensland, 4120, Australia

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

    Gold Coast, Queensland, 4215, Australia

  • Gustave Roussy ( Site 1909)

    Villejuif, Île-de-France Region, 94800, France

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

    Győr, 9024, Hungary

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

    Málaga, Malaga, 29010, Spain

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

    Barcelona, Catalonia, 08036, Spain

  • Hadassah Medical Center ( Site 2201)

    Jerusalem, 9112001, Israel

  • Harbour Cancer & Wellness ( Site 3300)

    Auckland, 1023, New Zealand

  • Hoag Memorial Hospital Presbyterian ( Site 1122)

    Newport Beach, California, 92663, United States

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

    Lille, Nord, 59037, France

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

    Valencia, Valenciana, Comunitat, 46014, Spain

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

    Badalona, Barcelona, 08916, Spain

  • Hospital Italiano de Córdoba ( Site 1204)

    Córdoba, X5004BAL, Argentina

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

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

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

    Barcelona, 08035, Spain

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

    Madrid, Madrid, Comunidad de, 28034, Spain

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

    Londrina, Paraná, 86015-520, Brazil

  • Hôpital Saint-Louis ( Site 1906)

    Paris, 75475, France

  • IPITEC ( Site 1313)

    São Paulo, São Paulo, 01223-001, Brazil

  • Inova Schar Cancer Institute ( Site 1108)

    Fairfax, Virginia, 22031, United States

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

    Toulouse, Haute-Garonne, 31059, France

  • Instituto Tumori Giovanni Paolo II ( Site 2301)

    Bari, Apulia, 70124, Italy

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

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Investigaciones Clinicas Moleculares (ICM) ( Site 1212)

    CABA, C1425BGH, Argentina

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

    Rozzano, Milano, 20089, Italy

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

    Naples, 80131, Italy

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

    Temuco, Araucania, 4800827, Chile

  • Jewish General Hospital ( Site 1009)

    Montreal, Quebec, H3T 1E2, Canada

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

    Hackensack, New Jersey, 07601, United States

  • Klinikum Dortmund Klinikzentrum Mitte ( Site 2008)

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Laura and Isaac Perlmutter Cancer Center ( Site 1121)

    New York, New York, 10016, United States

  • Massachusetts General Hospital ( Site 1162)

    Boston, Massachusetts, 02114, United States

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

    Wollstonecraft, New South Wales, 2065, Australia

  • NCT ( Site 2002)

    Heidelberg, Baden-Wurttemberg, 69120, Germany

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

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Ochsner Clinic Foundation ( Site 1113)

    New Orleans, Louisiana, 70121, United States

  • Oncologos del Occidente ( Site 1504)

    Pereira, Risaralda Department, 660001, Colombia

  • One Clinical Research ( Site 3211)

    Nedlands, Western Australia, 6009, Australia

  • Oslo universitetssykehus, Radiumhospitalet ( Site 2400)

    Oslo, 0379, Norway

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

    Genoa, Liguria, 16132, Italy

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

    Mineola, New York, 11501, United States

  • Providence Portland Medical Center ( Site 1102)

    Portland, Oregon, 97213, United States

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

    Pécs, Baranya, 7632, Hungary

  • Rabin Medical Center ( Site 2202)

    Petah Tikva, 4941492, Israel

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

    Brisbane, Queensland, 4029, Australia

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

    Florești, Cluj, 407280, Romania

  • Sanatorio Finochietto ( Site 1202)

    Buenos Aires, C1187AAN, Argentina

  • Sheba Medical Center ( Site 2200)

    Ramat Gan, 5265601, Israel

  • Sigmedical Services SRL ( Site 2603)

    Suceava, 720214, Romania

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

    Swansea, SA2 8QA, United Kingdom

  • Spitalul Universitar de Urgență Elias ( Site 2600)

    Bucharest, Bucharest, 011461, Romania

  • Stanford Cancer Center ( Site 1109)

    Palo Alto, California, 94304, United States

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

    Birtinya, Queensland, 4575, Australia

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

    Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

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

    Szeged, Csongrád megye, 6720, Hungary

  • UPMC Hillman Cancer Center ( Site 1107)

    Pittsburgh, Pennsylvania, 15232, United States

  • USC/Norris Comprehensive Cancer Center ( Site 1112)

    Los Angeles, California, 90033, United States

  • UZ Gent-Medical oncology ( Site 1702)

    Ghent, Oost-Vlaanderen, 9000, Belgium

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

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitaetsklinikum Tuebingen-Hautklinik ( Site 2003)

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 2001)

    Würzburg, Bavaria, 97080, Germany

  • University Hospital and UW Health Clinics ( Site 1119)

    Madison, Wisconsin, 53792, United States

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

    Sacramento, California, 95817, United States

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

    Iowa City, Iowa, 52242, United States

  • University of Kentucky Chandler Medical Center ( Site 1101)

    Lexington, Kentucky, 40536, United States

  • University of Virginia Health System ( Site 1115)

    Charlottesville, Virginia, 22908, United States

  • Universitätsklinikum Schleswig-Holstein-Dermatology ( Site 2012)

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 2007)

    Mainz, Rhineland-Palatinate, 55131, Germany

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

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

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

    Prague, Praha 2, 12808, Czechia

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

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute, Emory University ( Site 1151)

    Atlanta, Georgia, 30322, United States

  • centre hospitalier lyon sud ( Site 1901)

    Pierre-Bénite, Rhone, 69310, France

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

    München, Bavaria, 81675, Germany

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