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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

415

Participants

Timeline

Start Date

June 4, 2019

Primary Completion Date

November 3, 2026

Study Completion Date

March 26, 2028

Conditions
Cutaneous Squamous Cell Carcinoma
Interventions
DRUG

Cemiplimab

Intravenous (IV) infusion over 30 minutes

DRUG

Placebo

Intravenous (IV) infusion over 30 minutes

Trial Locations (166)

1023

Regeneron Study Site, Auckland

1200

Cliniques Universitaires Saint-Luc, Brussels

2060

Melanoma Institute, Sydney

2065

North Shore Private Hospital, St Leonards

2145

Westmead Hospital, Westmead

2170

Liverpool Cancer Therapy Center, Liverpool

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

2217

St George Hospital, Kogarah

2250

Central Coast Cancer Centre-Gosford and Wyong Hospitals, Gosford

2298

Calvary Mater Newcastle, Waratah

2450

Coffs Harbour Health Campus, Coffs Harbour

2500

Illawarra Cancer Care Centre (ICCC), Wollongong

2640

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

2650

Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC), Wagga Wagga

3000

Peter Maccallum Cancer Centre (PMCC), Melbourne

Universitair Ziekenhuis Leuven Gasthuisberg Campus, Leuven

3065

St. Vincent's Hospital, Fitzroy

3084

Olivia Newton -John Cancer Wellness & Research Centre, Heidelberg

3550

Bendigo Health, Bendigo

4029

The Royal Brisbane and Women's Hospital, Herston

4102

Princess Alexandra Hospital, Woolloongabba

4215

ICON Cancer Care, Southport

4224

Genesis Care Tugun - John Flynn Private Hospital, Tugun

4350

Toowoomba Hospital, Toowoomba

4410

Palmerston North Hospital, Palmerston North

4655

Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay, Urraween

4670

Wide Bay Hospital and Health Service - Cancer Care Services, Bundaberg

4814

The Townsville Hospital and Health Service, Townsville

4870

Cairns Hospital, Cairns

5000

Royal Adelaide Hospital, Adelaide

5037

Ashford Cancer Centre Research-Adelaide Cancer Centre, Kurralta Park

6009

Sir Charles Gairdner Hospital, Nedlands

7000

Royal Hobart Hospital-Hobart Hospital, Hobart

Royal Hobart Hospital, Hobart

7504

CIC Cochin Pasteur, Hopital Cochin, Paris

8916

Catalan institute of Oncology Badalona, Badalona

10016

NYU Langone Health, New York

10032

Columbia University, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10117

Charite- Universitaetsmedizin Berlin, Berlin

10126

AOU Citta della Salute e della Scienza di Torino, Torino

10604

Memorial Sloan Kettering, Harrison

11553

Memorial Sloan Kettering, Uniondale

11725

Memorial Sloan Kettering, Commack

16121

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

17025

Penn State Hershey Children's Hospital, Hershey

19104

University of Pennsylvania, Philadelphia

20037

George Washington University School of Medicine and Health Sciences, Washington D.C.

20089

IRCCS Istituto Clinico Humanitas, Rozzano

20141

IRCCS-Istituto Europeo di Oncologia, Milan

21079

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

21287

Regeneron Study Site, Baltimore

21614

Elbekliniken Buxtehude, Buxtehude

22908

University Of Virginia Health System, Charlottesville

24105

Universitaetsklinikum Schleswig-Holstein, Campus Kiel, Kiel

24128

ASST Papa Giovanni XXIII, Bergamo

25121

University of Brescia, Brescia

28002

Genesis Care hospital San Francisco de Asis, Madrid

28007

Hospital General Universitario Gregorio Maranon (HGUGM), Madrid

28027

Clinica Universidad de Navarra, Madrid

28041

Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias, Madrid

28222

Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda

28850

Hospital Universitario de Torrejon, Torrejón de Ardoz

28922

Hospital Universitario Fundacion Alcorcon, Alcorcón

30342

Regeneron Study Site, Atlanta

33136

Sylvester Comprehensive Cancer Center, Miami

33176

Miami Cancer Institute at Baptist Health, Inc., Miami

33604

Hopital Saint Andre - CHU de Bordeaux, Bordeaux

33612

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

33756

N.N.Blokhin Cancer Research Center, Moscow

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37203

Sarah Cannon Research Institute - Tennessee Oncology, Nashville

38700

Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon, La Tronche

40138

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

40202

Regeneron Study Site, Louisville

41009

Hospital Universitario Virgen Macarena-merge, Seville

43100

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

43230

The Ohio State University, Gahanna

44093

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

44791

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

45147

Universitaetsklinikum Essen (AoR), Essen

45267

Regeneron Research Site, Cincinnati

46009

Instituto Valenciano de Oncología, Valencia

46026

Hospital Universitario y Politecnico La Fe-merge, Valencia

48109

Michigan Medicine- University of Michigan, Ann Arbor

50125

Universita di Firenze - Azienda Sanitaria Firenze, Florence

50937

Klinikum der Universitaet zu Koeln, Cologne

55131

Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR, Mainz

59037

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez, Lille

60611

Regeneron Study Site, Chicago

63110

Washington University in Saint Louis, St Louis

65212

University of Missouri Health Care - University Physicians - Medicine Specialty Clinic, Columbia

67100

University L'Aquila, L’Aquila

68114

Nebraska Methodist Hospital, Omaha

69008

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

69120

NCT Dermatoonkologie -Hautklinik Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72076

University Hospital Tuebingen, Tübingen

74078

SLK-Kliniken Heilbronn GmbH, Heilbronn

75246

Texas Oncology - Baylor Charles A. Simmons Cancer Center, Dallas

75390

UT Southwestern Medical Center, Dallas

75475

Hospital Saint-Louis - APHP, Paris

76031

Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle, Rouen

80131

UOC Oncoematologia AOU Luigi Vanvitelli, Naples

80337

LMU Munchen, München

85054

Mayo Clinic Hospital, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

90025

The Angeles Clinic, Los Angeles

90033

University of Southern California (USC), Los Angeles

92100

Hopital Ambroise Pare, Boulogne-Billancourt

94304

Stanford Cancer Institute, Stanford Medicine at Stanford University, Palo Alto

94805

Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP, Villejuif

198255

Regeneron Study Site, Saint Petersburg

344037

Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation, Rostov-on-Don

354057

State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region, Sochi

357502

SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary, Pyatigorsk

455001

Regeneron Study Site, Magnitogorsk

644013

Regeneron Research Site, Omsk

85724-5024

Regeneron Study Site, Tucson

94143-0981

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

032608

University of Florida Health, Gainesville

02114

Massachusetts General Cancer Center, Boston

02215

Dana Farber/Harvard Cancer Center, Boston

07920

Memorial Sloan Kettering, Basking Ridge

07748

Memorial Sloan Kettering, Middletown

07645

Memorial Sloan Kettering, Montvale

08903

Memorial Sloan Kettering, New Brunswick

35160-158

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

90610-000

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos

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

20220-410

Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA, Santo Cristo

99010-080

Hospital Sao Vicente de Paulo (HSVP), Passo Fundo

88301-220

Centro De Novos Tratamentos Itajai, Itajaí

88501-001

ANIMI, Lages

08730-500

Centro Oncologico Mogi das Cruzes, Mogi das Cruzes

14049-900

Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP, Ribeirão Preto

88020-210

Ynova pesquisa clinica, Florianópolis

05403-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

M5G 2M9

University Health Network- Princess Margaret Cancer Center, Toronto

06202

Centre Hospitalier Universitaire de Nice,Hopital l Archet, Nice

01307

University Hospital Dresden, Dresden

546 23

Office of Dr. Aimilios Lallas MD, Thessaloniki

DO4 YN63

St. Vincent's University Hospital, Dublin

Unknown

University College Cork-Cork University Maternity Hospital, Cork

H91 YR71

University Hospital Galway, Galway

089263

ASST Spedali Civili Brescia, Brescia

00168

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

060-8543

Sapporo Medical University Hospital, Sapporo

411-8777

Shizuoka Cancer Center - Oncology, Nagaizumi-Cho

104-0045

National Cancer Center Hospital - Gastrointestinal Oncology, Chuo-ku

951-8566

Niigata Cancer Center Hospital, Niigata

541-8567

Osaka International Cancer Institute - Clinical Oncology, Osaka

44-102

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

30-820

Regeneron Study Site, Krakow

61-306

Regeneron Study Site, Poznan

04-141

Regeneron Study Site, Warsaw

20-090

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warsaw

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

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

PL6 8DH

Derriford Hospital, Plymouth

BS2 8ED

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

CF14 2TL

Velindre NHS Trust, Velindre Cancer Centre, Cardiff

EH4 2XU

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

G12 0YN

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

SW17 0QT

St George's Hospital - St George's University Hospitals NHS Foundation Trust, London

M20 4QL

The Christie - The Christie NHS Foundation Trust, Manchester

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY