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

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

Study Overview

• Status: Recruiting
• Conditions: Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Cemiplimab; Drug: Placebo

Detailed Description

Cemiplimab is a monoclonal antibody. Antibodies are proteins naturally found in the blood. A monoclonal antibody is a special antibody that is manufactured as a medication to target specific proteins in the body that may be involved in cancer. Cemiplimab works by blocking programmed death-1 (PD-1), a cell receptor on immune cells. By blocking PD-1, it is expected that the immune cells will attack cancer cells.

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).

• Study Type: Interventional
• Enrollment (Estimated): 412
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Recruiting
    • Royal Adelaide Hospital
  • Liverpool, Australia, 2170
    • Recruiting
    • Liverpool Cancer Therapy Center
  • Liverpool, Australia, 2170
    • Recruiting
    • University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
  • Townsville, Australia, 4814
    • Recruiting
    • The Townsville Hospital and Health Service
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Recruiting
      • The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
    • Coffs Harbour, New South Wales, Australia, 2450
      • Active, not recruiting
      • Coffs Harbour Health Campus
    • Gosford, New South Wales, Australia, 2250
      • Recruiting
      • Central Coast Cancer Centre-Gosford and Wyong Hospitals
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • St George Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • North Shore Private Hospital
    • Wagga Wagga, New South Wales, Australia, 2650
      • Recruiting
      • Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Newcastle
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Illawarra Cancer Care Centre (ICCC)
  • North South Wales
    • Sydney, North South Wales, Australia, 2060
      • Recruiting
      • Melanoma Institute
  • Queensland
    • Bundaberg, Queensland, Australia, 4670
      • Recruiting
      • Wide Bay Hospital and Health Service - Cancer Care Services
    • Cairns, Queensland, Australia, 4870
      • Recruiting
      • Cairns Hospital
    • Herston, Queensland, Australia, 4029
      • Recruiting
      • The Royal Brisbane and Women's Hospital
    • Southport, Queensland, Australia, 4215
      • Recruiting
      • Icon Cancer Care
    • Toowoomba, Queensland, Australia, 4350
      • Recruiting
      • Toowoomba Hospital
    • Tugun, Queensland, Australia, 4224
      • Recruiting
      • Genesis Care Tugun - John Flynn Private Hospital
    • Urraween, Queensland, Australia, 4655
      • Recruiting
      • Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Recruiting
      • Ashford Cancer Centre Research-Adelaide Cancer Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Royal Hobart Hospital
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Royal Hobart Hospital-Hobart Hospital
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Recruiting
      • Bendigo Health
    • Fitzroy, Victoria, Australia, 3065
      • Recruiting
      • St. Vincent's Hospital
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Olivia Newton -John Cancer Wellness & Research Centre
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter Maccallum Cancer Centre (PMCC)
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Sir Charles Gairdner Hospital
• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • Universitair Ziekenhuis Leuven Gasthuisberg Campus
• Brazil
  • Florianopolis, Brazil, 88020-210
    • Recruiting
    • YNOVA Pesquisa Clinica
  • Sao Paulo, Brazil, 05403-000
    • Recruiting
    • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Minas Gerais
    • Ipatinga, Minas Gerais, Brazil, 35160-158
      • Recruiting
      • Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I
  • Porte Alegre
    • Barretos, Porte Alegre, Brazil, 90610-000
      • Recruiting
      • Fundação Pio XII - Hospital de Câncer de Barretos
  • Rio De Janiero
    • Santo Cristo, Rio De Janiero, Brazil, 20220-410
      • Recruiting
      • Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
      • Recruiting
      • Hospital Sao Vicente de Paulo (HSVP)
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Recruiting
      • Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
  • Santa Catarina
    • Itajai, Santa Catarina, Brazil, 88301-220
      • Recruiting
      • Centro De Novos Tratamentos Itajai
    • Lajes, Santa Catarina, Brazil, 88501-001
      • Recruiting
      • ANIMI
  • Sao Paulo
    • Mogi das Cruzes, Sao Paulo, Brazil, 08730-500
      • Recruiting
      • Centro Oncologico Mogi das Cruzes
    • Ribeirao Preto, Sao Paulo, Brazil, 14049-900
      • Recruiting
      • Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network- Princess Margaret Cancer Center
• France
  • Bordeaux, France, 33604
    • Recruiting
    • Hopital Saint Andre - CHU de Bordeaux
  • Boulogne Billancourt, France, 92100
    • Recruiting
    • Hôpital Ambroise Paré
  • La Tronche, France, 38700
    • Recruiting
    • Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon
  • Lille, France, 59037
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
  • Lyon, France, 69008
    • Recruiting
    • Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
  • Nantes, France, 44093
    • Recruiting
    • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
  • Nice, France, 06202
    • Recruiting
    • Centre Hospitalier Universitaire de Nice,Hopital L Archet
  • Paris, France, 7504
    • Recruiting
    • CIC Cochin Pasteur, Hopital Cochin
  • Paris Cedex 10, France, 75475
    • Recruiting
    • Hospital Saint-Louis - APHP
  • Pierre Benite Cedex, France, 69495
    • Recruiting
    • Centre Hospitalier Lyon Sud
  • Rouen cedex, France, 76031
    • Recruiting
    • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
  • Villejuif Cedex, France, 94805
    • Recruiting
    • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
  • Dijon Cedex
    • Dijon, Dijon Cedex, France, 21079
      • Recruiting
      • Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charite- Universitaetsmedizin Berlin
  • Bochum, Germany, 44791
    • Recruiting
    • Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital
  • Buxtehude, Germany, 21614
    • Recruiting
    • Elbekliniken Buxtehude
  • Dresden, Germany, 01307
    • Recruiting
    • University Hospital Dresden
  • Essen, Germany, 45147
    • Recruiting
    • Universitaetsklinikum Essen (AoR)
  • Heilbronn, Germany, 74078
    • Recruiting
    • SLK-Kliniken Heilbronn GmbH
  • Kiel, Germany, 24105
    • Recruiting
    • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Koeln, Germany, 50937
    • Recruiting
    • Klinikum der Universitaet zu Koeln
  • Muenchen, Germany, 80337
    • Recruiting
    • LMU Munchen
  • Tuebingen, Germany, 72076
    • Recruiting
    • University Hospital Tuebingen
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • NCT Dermatoonkologie -Hautklinik Heidelberg
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Recruiting
      • Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
• Greece
  • Thessaloniki, Greece, 546 23
    • Recruiting
    • Office of Dr. Aimilios Lallas MD
  • Attiki
    • Athens, Attiki, Greece, 16121
      • Recruiting
      • University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros
• Ireland
  • Cork, Ireland
    • Recruiting
    • University College Cork-Cork University Maternity Hospital
  • Galway, Ireland, H91 YR71
    • Recruiting
    • University Hospital Galway
  • Leinster
    • Dublin, Leinster, Ireland, DO4 YN63
      • Recruiting
      • St. Vincent's University Hospital
• Italy
  • Bergamo, Italy, 24128
    • Recruiting
    • ASST Papa Giovanni XXIII
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna
  • Brescia, Italy, 25121
    • Recruiting
    • University of Brescia
  • Brescia, Italy, 089263
    • Recruiting
    • ASST Spedali Civili Brescia
  • Firenze, Italy, 50125
    • Recruiting
    • Universita di Firenze - Azienda Sanitaria Firenze
  • L'Aquila, Italy, 67100
    • Recruiting
    • University L'Aquila
  • Milan, Italy, 20141
    • Recruiting
    • IRCCS-Istituto Europeo di Oncologia
  • Naples, Italy, 80131
    • Recruiting
    • UOC Oncoematologia AOU Luigi Vanvitelli
  • Napoli, Italy, 43100
    • Recruiting
    • U.O.S.C Di Oncologia Medica E Terapie Innovative
  • Rome, Italy, 00168
    • Recruiting
    • A. Gemelli University Hospital, Catholic University of the Sacred Heart
  • Rozzano, Italy, 20089
    • Recruiting
    • IRCCS Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • Recruiting
    • AOU Città della Salute e della Scienza di Torino
• Japan
  • Niigata, Japan, 951-8566
    • Recruiting
    • NIigata Cancer Center Hospital
  • Osaka, Japan, 541-8567
    • Recruiting
    • Osaka International Cancer Institute - Clinical Oncology
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Recruiting
      • Sapporo Medical University Hospital
  • Shizuoka
    • Nagaizumi-Cho, Shizuoka, Japan, 411-8777
      • Recruiting
      • Shizuoka Cancer Center - Oncology
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital - Gastrointestinal Oncology
• New Zealand
  • Auckland, New Zealand, 1023
    • Completed
    • Regeneron study Site
  • Palmerston North, New Zealand, 4410
    • Recruiting
    • Palmerston North Hospital
• Poland
  • Gliwice, Poland, 44-102
    • Recruiting
    • Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach
  • Krakow, Poland, 30-820
    • Completed
    • Regeneron study Site
  • Poznan, Poland, 61-306
    • Completed
    • Regeneron study Site
  • Warsaw, Poland, 04-141
    • Completed
    • Regeneron study Site
  • Warszawa, Poland, 20-090
    • Recruiting
    • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
• Russian Federation
  • Magnitogorsk, Russian Federation, 455001
    • Completed
    • Regeneron study Site
  • Moscow, Russian Federation, 33756
    • Active, not recruiting
    • N.N.Blokhin Cancer Research Center
  • Omsk, Russian Federation, 644013
    • Completed
    • Regeneron Research Site
  • Rostov-Na-Donu, Russian Federation, 344037
    • Active, not recruiting
    • Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation
  • Saint Petersburg, Russian Federation, 198255
    • Completed
    • Regeneron study Site
  • Krasnodar Krai
    • Sochi, Krasnodar Krai, Russian Federation, 354057
      • Active, not recruiting
      • State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation, 357502
      • Active, not recruiting
      • SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary
• Spain
  • Badalona, Spain, 8916
    • Recruiting
    • Catalan Institute of Oncology Badalona
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Universidad de Navarra
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon (HGUGM)
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
  • Madrid, Spain, 28002
    • Recruiting
    • Genesis Care hospital San Francisco de Asis
  • Majadahonda, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro de Majadahonda
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Clinico Universitario de Salamanca
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena-merge
  • Valencia, Spain, 46009
    • Recruiting
    • Instituto Valenciano de Oncologia
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politecnico La Fe-merge
  • Cataluna
    • Barcelona, Cataluna, Spain, 08035
      • Recruiting
      • Hospital Universitari Vall d'Hebron
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Recruiting
      • Hospital Universitario Fundacion Alcorcon
    • Torrejon de Ardoz, Madrid, Spain, 28850
      • Recruiting
      • Hospital Universitario de Torrejón
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
    • Velindre NHS Trust, Velindre Cancer Centre
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • The Lothian University Hospitals NHS Lothian - Western General Hospital (WGH)
  • Glasgow, United Kingdom, G12 0YN
    • Recruiting
    • Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
  • London, United Kingdom, SW17 0QT
    • Completed
    • St George's Hospital - St George's University Hospitals NHS Foundation Trust
  • Manchester, United Kingdom, M20 4QL
    • Recruiting
    • The Christie - The Christie NHS Foundation Trust
  • Devon
    • Plymouth, Devon, United Kingdom, Pl6 8DH
      • Recruiting
      • Derriford Hospital
  • Somerset
    • Bristol, Somerset, United Kingdom, BS2 8ED
      • Recruiting
      • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Recruiting
      • Banner MD Anderson Cancer Center
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Hospital
    • Tucson, Arizona, United States, 85724-5024
      • Completed
      • Regeneron study Site
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California (USC)
    • Los Angeles, California, United States, 90025
      • Completed
      • The Angeles Clinic
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford Cancer Institute, Stanford Medicine at Stanford University
    • San Francisco, California, United States, 94143-0981
      • Completed
      • University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Recruiting
      • George Washington University School of Medicine and Health Sciences
  • Florida
    • Gainesville, Florida, United States, 032608
      • Completed
      • University of Florida Health
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Cancer Institute at Baptist Health, Inc.
    • Miami, Florida, United States, 33136
      • Completed
      • Sylvester Comprehensive Cancer Center
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Completed
      • Regeneron study Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Completed
      • Regeneron study Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Completed
      • Regeneron study Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Completed
      • Regeneron study Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Cancer Center
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber/Harvard Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Michigan Medicine- University of Michigan
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri Health Care - University Physicians - Medicine Specialty Clinic
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in Saint Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Nebraska Methodist Hospital
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Active, not recruiting
      • Memorial Sloan Kettering
    • Middletown, New Jersey, United States, 07748
      • Active, not recruiting
      • Memorial Sloan Kettering
    • Montvale, New Jersey, United States, 07645
      • Active, not recruiting
      • Memorial Sloan Kettering
    • New Brunswick, New Jersey, United States, 08903
      • Active, not recruiting
      • Memorial Sloan Kettering
  • New York
    • Commack, New York, United States, 11725
      • Active, not recruiting
      • Memorial Sloan Kettering
    • Harrison, New York, United States, 10604
      • Active, not recruiting
      • Memorial Sloan Kettering
    • New York, New York, United States, 10065
      • Active, not recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
    • New York, New York, United States, 10016
      • Completed
      • NYU Langone Health
    • Uniondale, New York, United States, 11553
      • Active, not recruiting
      • Memorial Sloan Kettering
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Completed
      • Regeneron Research Site
    • Gahanna, Ohio, United States, 43230
      • Recruiting
      • The Ohio State University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17025
      • Recruiting
      • Penn State Hershey Children's Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute - Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75246
      • Completed
      • Texas Oncology - Baylor Charles A. Simmons Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Intravenous (IV) infusion over 30 minutes
Experimental: Cemiplimab	Drug: Cemiplimab; Intravenous (IV) infusion over 30 minutes; Other Names: REGN2810; Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.	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.	For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.	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
Incidence of deaths		Up to 78 months
Incidence of laboratory abnormalities		Up to 78 months
Cemiplimab concentrations in serum		Up to 78 months
Anti-drug antibodies (ADA) in serum		Up to 78 months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): January 28, 2028

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: High risk
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1788; 2019-000566-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data 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, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No