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New drug may keep High-Risk skin cancer from coming back

NCT ID NCT03969004

Disease control Sponsor: Regeneron Pharmaceuticals 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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests whether adding the drug cemiplimab (Libtayo) after surgery and radiation helps prevent high-risk cutaneous squamous cell carcinoma from returning. About 415 participants receive either cemiplimab or a placebo intravenously every 3 weeks. The study compares how long patients stay cancer-free and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cemiplimab (Libtayo)
What this could lead to
If successful, this could provide a new standard treatment to reduce the risk of skin cancer returning after surgery and radiation.
What could go wrong
This is a Phase 3 trial, but results are not yet available. Cemiplimab may cause immune-related side effects, and it is not a cure—patients still need monitoring.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

415 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Jan 2028

An estimate. End dates often move.

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.

Key Inclusion Criteria: * For Japan only, men and women ≥21 years old * Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease * High risk CSCC, as defined in the protocol * Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization * Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1 * Adequate hepatic, renal, and bone marrow function as defined in the protocol Key Exclusion Criteria: * Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol * Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol * Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment) * Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary) * Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment. * Has had prior systemic anti-cancer immunotherapy for CSCC Note: Other protocol defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

skin squamous cell carcinoma

As listed by the trial registrant

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

Cutaneous squamous cell carcinoma

Contacts and locations

Locations

  • A. Gemelli University Hospital, Catholic University of the Sacred Heart

    Rome, 00168, Italy

  • ANIMI

    Lages, Santa Catarina, 88501-001, Brazil

  • AOU Citta della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • ASST Papa Giovanni XXIII

    Bergamo, 24128, Italy

  • ASST Spedali Civili Brescia

    Brescia, 089263, Italy

  • Ashford Cancer Centre Research-Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037, Australia

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

    Glasgow, G12 0YN, United Kingdom

  • Bendigo Health

    Bendigo, Victoria, 3550, Australia

  • CIC Cochin Pasteur, Hopital Cochin

    Paris, 7504, France

  • Cairns Hospital

    Cairns, Queensland, 4870, Australia

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)

    Wagga Wagga, New South Wales, 2650, Australia

  • Catalan institute of Oncology Badalona

    Badalona, 8916, Spain

  • Central Coast Cancer Centre-Gosford and Wyong Hospitals

    Gosford, New South Wales, 2250, Australia

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage

    Dijon, Dijon Cedex, 21079, France

  • Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon

    La Tronche, 38700, France

  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu

    Nantes, 44093, France

  • Centre Hospitalier Universitaire de Nice,Hopital l Archet

    Nice, 06202, France

  • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

    Rouen, 76031, France

  • Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

    Lyon, 69008, France

  • Centro De Novos Tratamentos Itajai

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Centro Oncologico Mogi das Cruzes

    Mogi das Cruzes, São Paulo, 08730-500, Brazil

  • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Charite- Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Clinica Universidad de Navarra

    Madrid, 28027, Spain

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450, Australia

  • Columbia University

    New York, New York, 10032, United States

  • Dana Farber/Harvard Cancer Center

    Boston, Massachusetts, 02215, United States

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Elbekliniken Buxtehude

    Buxtehude, 21614, Germany

  • Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation

    Rostov-on-Don, 344037, Russia

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, Porte Alegre, 90610-000, Brazil

  • Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I

    Ipatinga, Minas Gerais, 35160-158, Brazil

  • Genesis Care Tugun - John Flynn Private Hospital

    Tugun, Queensland, 4224, Australia

  • Genesis Care hospital San Francisco de Asis

    Madrid, 28002, Spain

  • George Washington University School of Medicine and Health Sciences

    Washington D.C., District of Columbia, 20037, United States

  • Hopital Ambroise Pare

    Boulogne-Billancourt, 92100, France

  • Hopital Saint Andre - CHU de Bordeaux

    Bordeaux, 33604, France

  • Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007, Spain

  • Hospital Saint-Louis - APHP

    Paris, 75475, France

  • Hospital Sao Vicente de Paulo (HSVP)

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

  • Hospital Universitari Vall d'Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222, Spain

  • Hospital Universitario Virgen Macarena-merge

    Seville, 41009, Spain

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850, Spain

  • Hospital Universitario y Politecnico La Fe-merge

    Valencia, 46026, Spain

  • Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP

    Ribeirão Preto, São Paulo, 14049-900, Brazil

  • ICON Cancer Care

    Southport, Queensland, 4215, Australia

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • IRCCS-Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Illawarra Cancer Care Centre (ICCC)

    Wollongong, New South Wales, 2500, Australia

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    Villejuif, 94805, France

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA

    Santo Cristo, Rio de Janiero, 20220-410, Brazil

  • Instituto Valenciano de Oncología

    Valencia, 46009, Spain

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, 05403-000, Brazil

  • Klinikum der Universitaet zu Koeln

    Cologne, 50937, Germany

  • LMU Munchen

    München, 80337, Germany

  • Liverpool Cancer Therapy Center

    Liverpool, 2170, Australia

  • Massachusetts General Cancer Center

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Melanoma Institute

    Sydney, North South Wales, 2060, Australia

  • Memorial Sloan Kettering

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering

    New Brunswick, New Jersey, 08903, United States

  • Memorial Sloan Kettering

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176, United States

  • Michigan Medicine- University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • N.N.Blokhin Cancer Research Center

    Moscow, 33756, Russia

  • NCT Dermatoonkologie -Hautklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • NYU Langone Health

    New York, New York, 10016, United States

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

    Warsaw, 20-090, Poland

  • Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach

    Gliwice, 44-102, Poland

  • National Cancer Center Hospital - Gastrointestinal Oncology

    Chuo-ku, Tokyo, 104-0045, Japan

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • North Shore Private Hospital

    St Leonards, New South Wales, 2065, Australia

  • Office of Dr. Aimilios Lallas MD

    Thessaloniki, 546 23, Greece

  • Olivia Newton -John Cancer Wellness & Research Centre

    Heidelberg, Victoria, 3084, Australia

  • Osaka International Cancer Institute - Clinical Oncology

    Osaka, 541-8567, Japan

  • Palmerston North Hospital

    Palmerston North, 4410, New Zealand

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17025, United States

  • Peter Maccallum Cancer Centre (PMCC)

    Melbourne, Victoria, 3000, Australia

  • Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

    Bologna, 40138, Italy

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Regeneron Research Site

    Cincinnati, Ohio, 45267, United States

  • Regeneron Research Site

    Omsk, 644013, Russia

  • Regeneron Study Site

    Tucson, Arizona, 85724-5024, United States

  • Regeneron Study Site

    Atlanta, Georgia, 30342, United States

  • Regeneron Study Site

    Chicago, Illinois, 60611, United States

  • Regeneron Study Site

    Louisville, Kentucky, 40202, United States

  • Regeneron Study Site

    Baltimore, Maryland, 21287, United States

  • Regeneron Study Site

    Auckland, 1023, New Zealand

  • Regeneron Study Site

    Krakow, 30-820, Poland

  • Regeneron Study Site

    Poznan, 61-306, Poland

  • Regeneron Study Site

    Warsaw, 04-141, Poland

  • Regeneron Study Site

    Magnitogorsk, 455001, Russia

  • Regeneron Study Site

    Saint Petersburg, 198255, Russia

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal Hobart Hospital-Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary

    Pyatigorsk, Stavropol Kray, 357502, Russia

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078, Germany

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543, Japan

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Shizuoka Cancer Center - Oncology

    Nagaizumi-Cho, Shizuoka, 411-8777, Japan

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • St George's Hospital - St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065, Australia

  • St. Vincent's University Hospital

    Dublin, Leinster, DO4 YN63, Ireland

  • Stanford Cancer Institute, Stanford Medicine at Stanford University

    Palo Alto, California, 94304, United States

  • State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region

    Sochi, Krasnodarskiy Kray, 354057, Russia

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • Texas Oncology - Baylor Charles A. Simmons Cancer Center

    Dallas, Texas, 75246, United States

  • The Angeles Clinic

    Los Angeles, California, 90025, United States

  • The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre

    Albury, New South Wales, 2640, Australia

  • The Christie - The Christie NHS Foundation Trust

    Manchester, M20 4QL, United Kingdom

  • The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)

    Edinburgh, EH4 2XU, United Kingdom

  • The Ohio State University

    Gahanna, Ohio, 43230, United States

  • The Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029, Australia

  • The Townsville Hospital and Health Service

    Townsville, 4814, Australia

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350, Australia

  • U.O.S.C Di Oncologia Medica E Terapie Innovative

    Naples, 43100, Italy

  • UOC Oncoematologia AOU Luigi Vanvitelli

    Naples, 80131, Italy

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Universita di Firenze - Azienda Sanitaria Firenze

    Florence, 50125, Italy

  • Universitaetsklinikum Essen (AoR)

    Essen, 45147, Germany

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital

    Bochum, 44791, Germany

  • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Universitair Ziekenhuis Leuven Gasthuisberg Campus

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University College Cork-Cork University Maternity Hospital

    Cork, Ireland

  • University Health Network- Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospital Dresden

    Dresden, 01307, Germany

  • University Hospital Galway

    Galway, H91 YR71, Ireland

  • University Hospital Tuebingen

    Tübingen, 72076, Germany

  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute

    Bristol, Somerset, BS2 8ED, United Kingdom

  • University L'Aquila

    L’Aquila, 67100, Italy

  • University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143-0981, United States

  • University Of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros

    Athens, Attica, 16121, Greece

  • University of Brescia

    Brescia, 25121, Italy

  • University of Florida Health

    Gainesville, Florida, 032608, United States

  • University of Missouri Health Care - University Physicians - Medicine Specialty Clinic

    Columbia, Missouri, 65212, United States

  • University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre

    Liverpool, 2170, Australia

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • University of Southern California (USC)

    Los Angeles, California, 90033, United States

  • Velindre NHS Trust, Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • Washington University in Saint Louis

    St Louis, Missouri, 63110, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wide Bay Hospital and Health Service - Cancer Care Services

    Bundaberg, Queensland, 4670, Australia

  • Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay

    Urraween, Queensland, 4655, Australia

  • Ynova pesquisa clinica

    Florianópolis, 88020-210, Brazil

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