Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Interventions
- Drug: Placebo
- Registration Number
- NCT03969004
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 412
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Cemiplimab Cemiplimab -
- Primary Outcome Measures
Name Time Method DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. Up to 54 months For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
- Secondary Outcome Measures
Name Time Method 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 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 For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.
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 For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.
Trial Locations
- Locations (149)
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite Cedex, France
Hospital Universitario Virgen Macarena-merge
🇪🇸Sevilla, Spain
Hospital Saint-Louis - APHP
🇫🇷Paris Cedex 10, France
CIC Cochin Pasteur, Hopital Cochin
🇫🇷Paris, France
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Universitario y Politecnico La Fe-merge
🇪🇸Valencia, Spain
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
🇫🇷Villejuif Cedex, France
University of Brescia
🇮🇹Brescia, Italy
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Regeneron Study Site
🇷🇺Saint Petersburg, Russian Federation
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, 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
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
🇺🇸Saint Louis, Missouri, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Memorial Sloan Kettering
🇺🇸Uniondale, 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
Regeneron Research Site
🇷🇺Omsk, Russian Federation
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
🇧🇪Bruxelles, 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
🇧🇷Itajai, Santa Catarina, Brazil
ANIMI
🇧🇷Lajes, Santa Catarina, Brazil
Centro Oncologico Mogi das Cruzes
🇧🇷Mogi das Cruzes, Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP
🇧🇷Ribeirao Preto, Sao Paulo, Brazil
Ynova pesquisa clinica
🇧🇷Florianopolis, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
🇧🇷Sao 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
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
🇫🇷Rouen cedex, France
NCT Dermatoonkologie -Hautklinik Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
🇩🇪Mainz, Rheinland-Pfalz, Germany
Charite- Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB), St. Josef Hospital
🇩🇪Bochum, Germany
Elbekliniken Buxtehude
🇩🇪Buxtehude, Germany
University Hospital Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Essen (AoR)
🇩🇪Essen, Germany
SLK-Kliniken Heilbronn GmbH
🇩🇪Heilbronn, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Klinikum der Universitaet zu Koeln
🇩🇪Koeln, Germany
LMU Munchen
🇩🇪Muenchen, Germany
University Hospital Tuebingen
🇩🇪Tuebingen, Germany
University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros
🇬🇷Athens, Attiki, 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
Universita di Firenze - Azienda Sanitaria Firenze
🇮🇹Firenze, 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
Palmerston North Hospital
🇳🇿Palmerston North, New Zealand
Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach
🇵🇱Gliwice, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
🇵🇱Warszawa, Poland
State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region
🇷🇺Sochi, Krasnodar Krai, Russian Federation
SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary
🇷🇺Pyatigorsk, Stavropol Region, Russian Federation
N.N.Blokhin Cancer Research Center
🇷🇺Moscow, Russian Federation
Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation
🇷🇺Rostov-Na-Donu, Russian Federation
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Cataluna, Spain
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcon, Madrid, Spain
Hospital Universitario de Torrejon
🇪🇸Torrejon 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
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