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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03969004
Collaborator
Sanofi (Industry)
412
Enrollment
143
Locations
2
Arms
92.8
Anticipated Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
412 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 4, 2019
Anticipated Primary Completion Date :
Dec 19, 2025
Anticipated Study Completion Date :
Feb 28, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cemiplimab

Drug: Cemiplimab
Intravenous (IV) infusion over 30 minutes
Other Names:
  • REGN2810
  • Libtayo

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Intravenous (IV) infusion over 30 minutes

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. 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.

    3. 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.

    4. 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]

    5. Incidence and severity of treatment-emergent adverse events (TEAE) [Up to 78 months]

    6. Incidence of deaths [Up to 78 months]

    7. Incidence of laboratory abnormalities [Up to 78 months]

    8. Cemiplimab concentrations in serum [Up to 78 months]

    9. Anti-drug antibodies (ADA) in serum [Up to 78 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    2 Regeneron Study Site Tucson Arizona United States 85724-5024
    3 The Angeles Clinic Los Angeles California United States 90025
    4 University of Southern California (USC) Los Angeles California United States 90033
    5 University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94143-0981
    6 George Washington University School of Medicine and Health Sciences Washington District of Columbia United States 20037
    7 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    8 University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    9 Regeneron Study Site Atlanta Georgia United States 30342
    10 Regeneron Study Site Chicago Illinois United States 60611
    11 Regeneron Study Site Louisville Kentucky United States 40202
    12 Regeneron Study Site Baltimore Maryland United States 21287
    13 Massachusetts General Cancer Center Boston Massachusetts United States 02114
    14 Dana Farber/Harvard Cancer Center Boston Massachusetts United States 02215
    15 University of Missouri Health Care - University Physicians - Medicine Specialty Clinic Columbia Missouri United States 65212
    16 Washington University in Saint Louis Saint Louis Missouri United States 63110
    17 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    18 Memorial Sloan Kettering Basking Ridge New Jersey United States 07920
    19 Memorial Sloan Kettering Middletown New Jersey United States 07748
    20 Memorial Sloan Kettering Montvale New Jersey United States 07645
    21 Memorial Sloan Kettering New Brunswick New Jersey United States 08903
    22 Memorial Sloan Kettering Commack New York United States 11725
    23 Memorial Sloan Kettering Harrison New York United States 10604
    24 NYU Langone Health New York New York United States 10016
    25 Columbia University New York New York United States 10032
    26 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    27 Memorial Sloan Kettering Uniondale New York United States 11553
    28 Regeneron Research Site Cincinnati Ohio United States 45267
    29 The Ohio State University Gahanna Ohio United States 43230
    30 Penn State Hershey Children's Hospital Hershey Pennsylvania United States 17025
    31 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    32 Sarah Cannon Research Institute - Tennessee Oncology Nashville Tennessee United States 37203
    33 Texas Oncology - Baylor Charles A. Simmons Cancer Center Dallas Texas United States 75246
    34 UT Southwestern Medical Center Dallas Texas United States 75390
    35 University Of Virginia Health System Charlottesville Virginia United States 22908
    36 The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre Albury New South Wales Australia 2640
    37 Coffs Harbour Health Campus Coffs Harbour New South Wales Australia 2450
    38 Central Coast Cancer Centre-Gosford and Wyong Hospitals Gosford New South Wales Australia 2250
    39 St George Hospital Kogarah New South Wales Australia 2217
    40 University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre Liverpool New South Wales Australia 2170
    41 North Shore Private Hospital St Leonards New South Wales Australia 2065
    42 Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC) Wagga Wagga New South Wales Australia 2650
    43 Calvary Mater Newcastle Waratah New South Wales Australia 2298
    44 Westmead Hospital Westmead New South Wales Australia 2145
    45 Illawarra Cancer Care Centre (ICCC) Wollongong New South Wales Australia 2500
    46 Wide Bay Hospital and Health Service - Cancer Care Services Bundaberg Queensland Australia 4670
    47 The Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
    48 ICON Cancer Care Southport Queensland Australia 4215
    49 Genesis Care Tugun - John Flynn Private Hospital Tugun Queensland Australia 4224
    50 Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay Urraween Queensland Australia 4655
    51 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    52 Ashford Cancer Centre Research-Adelaide Cancer Centre Kurralta Park South Australia Australia 5037
    53 Royal Hobart Hospital-Hobart Hospital Hobart Tasmania Australia 7000
    54 Bendigo Health Bendigo Victoria Australia 3550
    55 St. Vincent's Hospital Fitzroy Victoria Australia 3065
    56 Olivia Newton -John Cancer Wellness & Research Centre Heidelberg Victoria Australia 3084
    57 Peter Maccallum Cancer Centre (PMCC) Melbourne Victoria Australia 3000
    58 Sir Charles Gairdner Hospital Nedlands Western Australia Australia 6009
    59 Royal Adelaide Hospital Adelaide Australia 5000
    60 The Townsville Hospital and Health Service Townsville Australia 4814
    61 Universitair Ziekenhuis Leuven Gasthuisberg Campus Leuven Vlaams-Brabant Belgium 3000
    62 Cliniques Universitaires Saint-Luc Bruxelles Belgium 1200
    63 Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I Ipatinga Minas Gerais Brazil 35160-158
    64 Fundacao Pio XII - Hospital de Cancer de Barretos Barretos Porte Alegre Brazil 90610-000
    65 Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA Santo Cristo Rio De Janiero Brazil 20220-410
    66 Hospital Sao Vicente de Paulo (HSVP) Passo Fundo Rio Grande Do Sul Brazil 99010-080
    67 Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS Porto Alegre Rio Grande Do Sul Brazil 90610-000
    68 Centro De Novos Tratamentos Itajai Itajai Santa Catarina Brazil 88301-220
    69 ANIMI Lajes Santa Catarina Brazil 88501-001
    70 Centro Oncologico Mogi das Cruzes Mogi das Cruzes Sao Paulo Brazil 08730-500
    71 Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP Ribeirao Preto Sao Paulo Brazil 14049-900
    72 Ynova pesquisa clinica Florianopolis Brazil 88020-210
    73 Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo Brazil 05403-000
    74 University Health Network- Princess Margaret Cancer Center Toronto Ontario Canada M5G 2M9
    75 Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage Dijon Dijon Cedex France 21079
    76 Hopital Saint Andre - CHU de Bordeaux Bordeaux France 33604
    77 Hopital Ambroise Pare Boulogne Billancourt France 92100
    78 Regeneron Study Site Grenoble Cedex 09 France 38043
    79 Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon La Tronche France 38700
    80 Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez Lille France 59037
    81 Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu Nantes France 44093
    82 Centre Hospitalier Universitaire de Nice,Hopital l Archet Nice France 06202
    83 Hospital Saint-Louis - APHP Paris Cedex 10 France 75475
    84 Centre Hospitalier Lyon Sud Pierre Benite Cedex France 69495
    85 Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle Rouen cedex France 76031
    86 Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP Villejuif Cedex France 94805
    87 NCT Dermatoonkologie -Hautklinik Heidelberg Heidelberg Baden-Württemberg Germany 69120
    88 Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR Mainz Rheinland-Pfalz Germany 55131
    89 Elbekliniken Buxtehude Buxtehude Germany 21614
    90 University Hospital Dresden Dresden Germany 01307
    91 Universitaetsklinikum Essen (AoR) Essen Germany 45147
    92 SLK-Kliniken Heilbronn GmbH Heilbronn Germany 74078
    93 Universitaetsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany 24105
    94 Klinikum der Universitaet zu Koeln Koeln Germany 50937
    95 LMU Munchen Muenchen Germany 80337
    96 University Hospital Tuebingen Tuebingen Germany 72076
    97 University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros Athens Attiki Greece 16121
    98 St. Vincent's University Hospital Dublin Leinster Ireland DO4 YN63
    99 University College Cork-Cork University Maternity Hospital Cork Ireland
    100 ASST Papa Giovanni XXIII Bergamo Italy 24128
    101 Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna Bologna Italy 40138
    102 University of Brescia Brescia Italy 25121
    103 Universita di Firenze - Azienda Sanitaria Firenze Firenze Italy 50125
    104 University L'Aquila L'Aquila Italy 67100
    105 IRCCS-Istituto Europeo di Oncologia Milan Italy 20141
    106 U.O.S.C Di Oncologia Medica E Terapie Innovative Napoli Italy 43100
    107 A. Gemelli University Hospital, Catholic University of the Sacred Heart Rome Italy 00168
    108 AOU Citta della Salute e della Scienza di Torino Torino Italy 10126
    109 Sapporo Medical University Hospital Sapporo Hokkaido Japan 060-8543
    110 Shizuoka Cancer Center - Oncology Nagaizumi-Cho Shizuoka Japan 411-8777
    111 National Cancer Center Hospital - Gastrointestinal Oncology Chuo-ku Tokyo Japan 104-0045
    112 Niigata Cancer Center Hospital Niigata Japan 951-8566
    113 Osaka International Cancer Institute - Clinical Oncology Osaka Japan 541-8567
    114 Regeneron Study Site Auckland New Zealand 1023
    115 Palmerston North Hospital Palmerston North New Zealand 4410
    116 Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach Gliwice Poland 44-102
    117 Regeneron Study Site Krakow Poland 30-820
    118 Regeneron Study Site Poznan Poland 61-306
    119 Regeneron Study Site Warsaw Poland 04-141
    120 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Warszawa Poland 20-090
    121 State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region Sochi Krasnodar Krai Russian Federation 354057
    122 SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary Pyatigorsk Stavropol Region Russian Federation 357502
    123 Regeneron Study Site Magnitogorsk Russian Federation 455001
    124 N.N.Blokhin Cancer Research Center Moscow Russian Federation 33756
    125 Regeneron Research Site Omsk Russian Federation 644013
    126 Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation Rostov-Na-Donu Russian Federation 344037
    127 Regeneron Study Site Saint Petersburg Russian Federation 198255
    128 Hospital Universitari Vall d'Hebron Barcelona Cataluna Spain 08035
    129 Hospital Universitario Fundacion Alcorcon Alcorcon Madrid Spain 28922
    130 Hospital Universitario de Torrejon Torrejon de Ardoz Madrid Spain 28850
    131 Catalan institute of Oncology Badalona Badalona Spain 8916
    132 Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO) Barcelona Spain 08036
    133 Hospital General Universitario Gregorio Maranon (HGUGM) Madrid Spain 28007
    134 Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias Madrid Spain 28041
    135 Hospital Clinico Universitario de Salamanca Salamanca Spain 37007
    136 Hospital Universitario Virgen Macarena-merge Sevilla Spain 41009
    137 Instituto Valenciano de Oncología Valencia Spain 46009
    138 Hospital Universitario y Politecnico La Fe-merge Valencia Spain 46026
    139 Derriford Hospital Plymouth Devon United Kingdom PL6 8DH
    140 Western General Hospital - Nhs Lothian - Lothian University Hospitals Division Edinburgh Scotland United Kingdom EH4 2XU
    141 University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute Bristol Somerset United Kingdom BS2 8ED
    142 St George's Hospital - St George's University Hospitals NHS Foundation Trust London United Kingdom SW17 0QT
    143 The Christie - The Christie NHS Foundation Trust Manchester United Kingdom M20 4QL

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Sanofi

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03969004
    Other Study ID Numbers:
    • R2810-ONC-1788
    • 2019-000566-38
    First Posted:
    May 31, 2019
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    High risk
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Cemiplimab

    Study Results

    No Results Posted as of Jul 22, 2022