Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
3 other identifiers
interventional
415
16 countries
166
Brief Summary
The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2019
Longer than P75 for phase_3
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
June 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 7, 2028
March 27, 2026
March 1, 2026
8.6 years
May 6, 2019
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.
For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
Up to 54 months
Secondary Outcomes (9)
Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive.
Up to 78 months
FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death.
Up to 54 months
Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death.
Up to 54 months
Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.
Up to 54 months
Incidence and severity of treatment-emergent adverse events (TEAE)
Up to 78 months
- +4 more secondary outcomes
Study Arms (2)
Cemiplimab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Has had prior systemic anti-cancer immunotherapy for CSCC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (166)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Regeneron Study Site
Tucson, Arizona, 85724-5024, United States
The Angeles Clinic
Los Angeles, California, 90025, United States
University of Southern California (USC)
Los Angeles, California, 90033, United States
Stanford Cancer Institute, Stanford Medicine at Stanford University
Palo Alto, California, 94304, United States
University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143-0981, United States
George Washington University School of Medicine and Health Sciences
Washington D.C., District of Columbia, 20037, United States
University of Florida Health
Gainesville, Florida, 032608, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, 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
Massachusetts General Cancer Center
Boston, Massachusetts, 02114, United States
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02215, United States
Michigan Medicine- University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Missouri Health Care - University Physicians - Medicine Specialty Clinic
Columbia, Missouri, 65212, United States
Washington University in Saint Louis
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
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
NYU Langone Health
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering
Uniondale, New York, 11553, United States
Regeneron Research Site
Cincinnati, Ohio, 45267, United States
The Ohio State University
Gahanna, Ohio, 43230, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17025, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University Of Virginia Health System
Charlottesville, Virginia, 22908, United States
The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
Albury, New South Wales, 2640, Australia
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450, Australia
Central Coast Cancer Centre-Gosford and Wyong Hospitals
Gosford, New South Wales, 2250, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
North Shore Private Hospital
St Leonards, New South Wales, 2065, Australia
Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)
Wagga Wagga, New South Wales, 2650, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Illawarra Cancer Care Centre (ICCC)
Wollongong, New South Wales, 2500, Australia
Melanoma Institute
Sydney, North South Wales, 2060, Australia
Wide Bay Hospital and Health Service - Cancer Care Services
Bundaberg, Queensland, 4670, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
The Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
ICON Cancer Care
Southport, Queensland, 4215, Australia
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Genesis Care Tugun - John Flynn Private Hospital
Tugun, Queensland, 4224, Australia
Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay
Urraween, Queensland, 4655, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Ashford Cancer Centre Research-Adelaide Cancer Centre
Kurralta Park, South Australia, 5037, Australia
Royal Hobart Hospital-Hobart Hospital
Hobart, Tasmania, 7000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Bendigo Health
Bendigo, Victoria, 3550, Australia
St. Vincent's Hospital
Fitzroy, Victoria, 3065, Australia
Olivia Newton -John Cancer Wellness & Research Centre
Heidelberg, Victoria, 3084, Australia
Peter Maccallum Cancer Centre (PMCC)
Melbourne, Victoria, 3000, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Adelaide Hospital
Adelaide, 5000, Australia
Liverpool Cancer Therapy Center
Liverpool, 2170, Australia
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, 2170, Australia
The Townsville Hospital and Health Service
Townsville, 4814, Australia
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, Vlaams-Brabant, 3000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
Ipatinga, Minas Gerais, 35160-158, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, Porte Alegre, 90610-000, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
Santo Cristo, Rio de Janiero, 20220-410, Brazil
Hospital Sao Vicente de Paulo (HSVP)
Passo Fundo, Rio Grande do Sul, 99010-080, 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
Centro De Novos Tratamentos Itajai
Itajaí, Santa Catarina, 88301-220, Brazil
ANIMI
Lages, Santa Catarina, 88501-001, Brazil
Centro Oncologico Mogi das Cruzes
Mogi das Cruzes, São Paulo, 08730-500, Brazil
Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP
Ribeirão Preto, São Paulo, 14049-900, Brazil
Ynova pesquisa clinica
Florianópolis, 88020-210, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, 05403-000, Brazil
University Health Network- Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage
Dijon, Dijon Cedex, 21079, France
Hopital Saint Andre - CHU de Bordeaux
Bordeaux, 33604, France
Hopital Ambroise Pare
Boulogne-Billancourt, 92100, France
Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
La Tronche, 38700, France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59037, France
Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, 69008, 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
CIC Cochin Pasteur, Hopital Cochin
Paris, 7504, France
Hospital Saint-Louis - APHP
Paris, 75475, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen, 76031, France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, 94805, France
NCT Dermatoonkologie -Hautklinik Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate, 55131, Germany
Charite- Universitaetsmedizin Berlin
Berlin, 10117, Germany
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital
Bochum, 44791, Germany
Elbekliniken Buxtehude
Buxtehude, 21614, Germany
Klinikum der Universitaet zu Koeln
Cologne, 50937, Germany
University Hospital Dresden
Dresden, 01307, Germany
Universitaetsklinikum Essen (AoR)
Essen, 45147, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
LMU Munchen
München, 80337, Germany
University Hospital Tuebingen
Tübingen, 72076, Germany
University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros
Athens, Attica, 16121, Greece
Office of Dr. Aimilios Lallas MD
Thessaloniki, 546 23, Greece
St. Vincent's University Hospital
Dublin, Leinster, DO4 YN63, Ireland
University College Cork-Cork University Maternity Hospital
Cork, Ireland
University Hospital Galway
Galway, H91 YR71, Ireland
ASST Papa Giovanni XXIII
Bergamo, 24128, Italy
Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna
Bologna, 40138, Italy
ASST Spedali Civili Brescia
Brescia, 089263, Italy
University of Brescia
Brescia, 25121, Italy
Universita di Firenze - Azienda Sanitaria Firenze
Florence, 50125, Italy
University L'Aquila
L’Aquila, 67100, Italy
IRCCS-Istituto Europeo di Oncologia
Milan, 20141, Italy
U.O.S.C Di Oncologia Medica E Terapie Innovative
Naples, 43100, Italy
UOC Oncoematologia AOU Luigi Vanvitelli
Naples, 80131, Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Rome, 00168, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
AOU Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Shizuoka Cancer Center - Oncology
Nagaizumi-Cho, Shizuoka, 411-8777, Japan
National Cancer Center Hospital - Gastrointestinal Oncology
Chuo-ku, Tokyo, 104-0045, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute - Clinical Oncology
Osaka, 541-8567, Japan
Regeneron Study Site
Auckland, 1023, New Zealand
Palmerston North Hospital
Palmerston North, 4410, New Zealand
Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach
Gliwice, 44-102, Poland
Regeneron Study Site
Krakow, 30-820, Poland
Regeneron Study Site
Poznan, 61-306, Poland
Regeneron Study Site
Warsaw, 04-141, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 20-090, Poland
State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region
Sochi, Krasnodarskiy Kray, 354057, Russia
SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk, Stavropol Kray, 357502, Russia
Regeneron Study Site
Magnitogorsk, 455001, Russia
N.N.Blokhin Cancer Research Center
Moscow, 33756, Russia
Regeneron Research Site
Omsk, 644013, Russia
Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation
Rostov-on-Don, 344037, Russia
Regeneron Study Site
Saint Petersburg, 198255, Russia
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Madrid, 28850, Spain
Catalan institute of Oncology Badalona
Badalona, 8916, Spain
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
Barcelona, 08036, Spain
Genesis Care hospital San Francisco de Asis
Madrid, 28002, Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, 28222, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Macarena-merge
Seville, 41009, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Universitario y Politecnico La Fe-merge
Valencia, 46026, Spain
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
Bristol, Somerset, BS2 8ED, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)
Edinburgh, EH4 2XU, United Kingdom
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow, G12 0YN, United Kingdom
St George's Hospital - St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
The Christie - The Christie NHS Foundation Trust
Manchester, M20 4QL, United Kingdom
Related Publications (1)
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.
PMID: 40454639DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 31, 2019
Study Start
June 4, 2019
Primary Completion (Estimated)
January 7, 2028
Study Completion (Estimated)
January 7, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
- Access Criteria
- Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing