Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
NCT ID: NCT03969004
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
415 participants
INTERVENTIONAL
2019-06-04
2028-03-26
Brief Summary
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The secondary objectives of the study are:
* To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
* To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT
* To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT
* To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
* To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT
* To assess cemiplimab pharmacokinetics and immunogenicity in human serum
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Detailed Description
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The study is being conducted in participants that have had surgery and radiation therapy for a type of skin cancer called cutaneous squamous cell cancer, and who have a risk that this cancer may come back.
The main purpose of the study is to determine if cemiplimab will prevent cutaneous squamous cell cancer (CSCC) from returning after surgery and radiation. Currently, we know that certain types of CSCC have a high chance of coming back after surgery and radiation. At this time, there is no approved treatment to give patients after surgery and radiation to prevent high-risk CSCC from coming back. We are investigating if the addition of cemiplimab will decrease the chance of these high-risk cancers coming back.
The study will also investigate if cemiplimab may help participants live for longer.
The study has two parts. Part 1: participants will receive every 3 weeks via intravenous infusion (drip into a vein) either cemiplimab (study drug) or placebo (similar to the study drug but without active medicine). After 12 weeks of treatment, cemiplimab or placebo will be given every 6 weeks. Part 1 of the study includes a screening period (up to 28 days), a treatment period (approximately 48 weeks), an end of treatment visit (approximately 30 days after completion of study drug treatment period) and a post-treatment follow-up period (approximately up to 5 years or until skin cancer returns or the study ends).
Part 2 of the study is optional and provides the participant with the option to receive cemiplimab if the cancer comes back if the participant was initially receiving placebo. There is no placebo in Part 2 of the study. If the cancer comes back, the study doctor will discuss with participants if they are eligible to participate in the optional part 2 of the study.
Part 2 of the study includes a brief screening period, a treatment period (approximately 96 weeks) and an end of treatment visit (approximately 30 days after the completion of the study drug treatment period).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cemiplimab
Cemiplimab
Intravenous (IV) infusion over 30 minutes
Placebo
Placebo
Intravenous (IV) infusion over 30 minutes
Interventions
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Cemiplimab
Intravenous (IV) infusion over 30 minutes
Placebo
Intravenous (IV) infusion over 30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Regeneron Study Site
Tucson, Arizona, United States
The Angeles Clinic
Los Angeles, California, United States
University of Southern California (USC)
Los Angeles, California, United States
Stanford Cancer Institute, Stanford Medicine at Stanford University
Palo Alto, California, United States
University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
George Washington University School of Medicine and Health Sciences
Washington D.C., District of Columbia, United States
University of Florida Health
Gainesville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Regeneron Study Site
Atlanta, Georgia, United States
Regeneron Study Site
Chicago, Illinois, United States
Regeneron Study Site
Louisville, Kentucky, United States
Regeneron Study Site
Baltimore, Maryland, United States
Massachusetts General Cancer Center
Boston, Massachusetts, United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, United States
Michigan Medicine- University of Michigan
Ann Arbor, Michigan, United States
University of Missouri Health Care - University Physicians - Medicine Specialty Clinic
Columbia, Missouri, United States
Washington University in Saint Louis
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Memorial Sloan Kettering
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering
Middletown, New Jersey, United States
Memorial Sloan Kettering
Montvale, New Jersey, United States
Memorial Sloan Kettering
New Brunswick, New Jersey, United States
Memorial Sloan Kettering
Commack, New York, United States
Memorial Sloan Kettering
Harrison, New York, United States
NYU Langone Health
New York, New York, United States
Columbia University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering
Uniondale, New York, United States
Regeneron Research Site
Cincinnati, Ohio, United States
The Ohio State University
Gahanna, Ohio, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
Albury, New South Wales, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia
Central Coast Cancer Centre-Gosford and Wyong Hospitals
Gosford, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
North Shore Private Hospital
St Leonards, New South Wales, Australia
Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)
Wagga Wagga, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Illawarra Cancer Care Centre (ICCC)
Wollongong, New South Wales, Australia
Melanoma Institute
Sydney, North South Wales, Australia
Wide Bay Hospital and Health Service - Cancer Care Services
Bundaberg, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
The Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
ICON Cancer Care
Southport, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Genesis Care Tugun - John Flynn Private Hospital
Tugun, Queensland, Australia
Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay
Urraween, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research-Adelaide Cancer Centre
Kurralta Park, South Australia, Australia
Royal Hobart Hospital-Hobart Hospital
Hobart, Tasmania, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Bendigo Health
Bendigo, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Olivia Newton -John Cancer Wellness & Research Centre
Heidelberg, Victoria, Australia
Peter Maccallum Cancer Centre (PMCC)
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Liverpool Cancer Therapy Center
Liverpool, , Australia
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, , Australia
The Townsville Hospital and Health Service
Townsville, , Australia
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, Vlaams-Brabant, Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
Ipatinga, Minas Gerais, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, Porte Alegre, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
Santo Cristo, Rio de Janiero, Brazil
Hospital Sao Vicente de Paulo (HSVP)
Passo Fundo, Rio Grande do Sul, Brazil
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro De Novos Tratamentos Itajai
Itajaí, Santa Catarina, Brazil
ANIMI
Lages, Santa Catarina, Brazil
Centro Oncologico Mogi das Cruzes
Mogi das Cruzes, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP
Ribeirão Preto, São Paulo, Brazil
Ynova pesquisa clinica
Florianópolis, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, , Brazil
University Health Network- Princess Margaret Cancer Center
Toronto, Ontario, Canada
Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage
Dijon, Dijon Cedex, France
Hopital Saint Andre - CHU de Bordeaux
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
La Tronche, , France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, , France
Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, , France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, , France
Centre Hospitalier Universitaire de Nice,Hopital l Archet
Nice, , France
CIC Cochin Pasteur, Hopital Cochin
Paris, , France
Hospital Saint-Louis - APHP
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen, , France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, , France
NCT Dermatoonkologie -Hautklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate, Germany
Charite- Universitaetsmedizin Berlin
Berlin, , Germany
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital
Bochum, , Germany
Elbekliniken Buxtehude
Buxtehude, , Germany
Klinikum der Universitaet zu Koeln
Cologne, , Germany
University Hospital Dresden
Dresden, , Germany
Universitaetsklinikum Essen (AoR)
Essen, , Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
LMU Munchen
München, , Germany
University Hospital Tuebingen
Tübingen, , Germany
University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros
Athens, Attica, Greece
Office of Dr. Aimilios Lallas MD
Thessaloniki, , Greece
St. Vincent's University Hospital
Dublin, Leinster, Ireland
University College Cork-Cork University Maternity Hospital
Cork, , Ireland
University Hospital Galway
Galway, , Ireland
ASST Papa Giovanni XXIII
Bergamo, , Italy
Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna
Bologna, , Italy
ASST Spedali Civili Brescia
Brescia, , Italy
University of Brescia
Brescia, , Italy
Universita di Firenze - Azienda Sanitaria Firenze
Florence, , Italy
University L'Aquila
L’Aquila, , Italy
IRCCS-Istituto Europeo di Oncologia
Milan, , Italy
UOC Oncoematologia AOU Luigi Vanvitelli
Naples, , Italy
U.O.S.C Di Oncologia Medica E Terapie Innovative
Napoli, , Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Rome, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
AOU Citta della Salute e della Scienza di Torino
Torino, , Italy
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Shizuoka Cancer Center - Oncology
Nagaizumi-Cho, Shizuoka, Japan
National Cancer Center Hospital - Gastrointestinal Oncology
Chuo-ku, Tokyo, Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Osaka International Cancer Institute - Clinical Oncology
Osaka, , Japan
Regeneron Study Site
Auckland, , New Zealand
Palmerston North Hospital
Palmerston North, , New Zealand
Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach
Gliwice, , Poland
Regeneron Study Site
Krakow, , Poland
Regeneron Study Site
Poznan, , Poland
Regeneron Study Site
Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region
Sochi, Krasnodarskiy Kray, Russia
SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk, Stavropol Kray, Russia
Regeneron Study Site
Magnitogorsk, , Russia
N.N.Blokhin Cancer Research Center
Moscow, , Russia
Regeneron Research Site
Omsk, , Russia
Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation
Rostov-on-Don, , Russia
Regeneron Study Site
Saint Petersburg, , Russia
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, Spain
Catalan institute of Oncology Badalona
Badalona, , Spain
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
Barcelona, , Spain
Genesis Care hospital San Francisco de Asis
Madrid, , Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Macarena-merge
Seville, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Universitario y Politecnico La Fe-merge
Valencia, , Spain
Derriford Hospital
Plymouth, Devon, United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
Bristol, Somerset, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, , United Kingdom
The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow, , United Kingdom
St George's Hospital - St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
The Christie - The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Rischin D, Porceddu S, Day F, Brungs DP, Christie H, Jackson JE, Stein BN, Su YB, Ladwa R, Adams G, Bowyer SE, Otty Z, Yamazaki N, Bossi P, Challapalli A, Hauschild A, Lim AM, Patel VA, Walker JL, De Liz Vassen Schurmann M, Queirolo P, Canueto J, Ferreira da Silva FA, Stratigos A, Guminski A, Lin C, Damian F, Flatz L, Taylor AE, Carr DR, Harris S, Kirtbaya D, Quereux G, Rutkowski P, Basset-Seguin N, Khushalani NI, Robert C, Ju H, Joseph C, Bansal S, Chen CI, Seebach F, Yoo SY, Lowy I, Goncalves P, Fury MG; C-POST Trial Investigators. Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2025 Aug 21;393(8):774-785. doi: 10.1056/NEJMoa2502449. Epub 2025 May 31.
Related Links
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Related Info
Other Identifiers
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2019-000566-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511653-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
R2810-ONC-1788
Identifier Type: -
Identifier Source: org_study_id
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