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ACTIVE NOT RECRUITING
NCT03969004
PHASE3

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

415

Start Date

2019-06-04

Completion Date

2028-01-07

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Cemiplimab

Intravenous (IV) infusion over 30 minutes

DRUG

Placebo

Intravenous (IV) infusion over 30 minutes

Locations (166)

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

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

Naples, Italy

UOC Oncoematologia AOU Luigi Vanvitelli

Naples, 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