Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
NCT ID: NCT02760498
Last Updated: 2025-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
432 participants
INTERVENTIONAL
2016-04-07
2023-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
cemiplimab
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
cemiplimab
Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
cemiplimab
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
cemiplimab
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W
Participants received a single subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
cemiplimab
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
cemiplimab
Interventions
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cemiplimab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate bone marrow function
* Adequate renal function
* Adequate hepatic function
* Archived or newly obtained tumor material
* Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6)
* Surgical or radiological treatment of lesions contraindicated
Exclusion Criteria
* Prior treatment with an agent that blocks the PD-1/PD-L1pathway
* Prior treatment with a BRAF inhibitor
* Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
* Untreated brain metastasis(es) that may be considered active
* Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
* Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
* History of non-infectious pneumonitis within the last 5 years
* Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
* Known allergy to doxycycline or tetracycline
* Patients with a history of solid organ transplant
* Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Fundacion Instituto Valenciano de Oncología
Valencia, , Spain
University of Arizona Cancer Center
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
City of Hope Hospital
Duarte, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University
Redwood City, California, United States
University of California, San Diego
San Diego, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
St. Louis University
St Louis, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
New York University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
St. Luke's Hematology Oncology Specialists
Easton, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Dermatology and Laser Center of Charleston
Charleston, South Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, , Brazil
Fundação São Francisco Xavier-Hospital Márcio Cunha
Ipatinga, , Brazil
Animi
Lages, , Brazil
Fundação Antônio Prudente - AC Camargo Câncer Center
São Paulo, , Brazil
Instituto do Cancer do Estado de São Paulo ICESP
São Paulo, , Brazil
Hôpital Claude Huriez
Lille, Nord, France
Hopital Avicenne
Bobigny, , France
Hôpital Saint-André
Bordeaux, , France
CHU Dijon Bourgogne
Dijon, , France
CHRU Grenoble
Grenoble, , France
Hopitaux de La Timone
Marseille, , France
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Hopital Cochin
Paris, , France
Hôpital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Gustave Roussy
Villejuif, , France
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
LMU Klinikum der Universität München
Munich, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Charitè Campus Mitte
Berlin, , Germany
SRH Wald-Klinikum Gera
Gera, , Germany
Andreas Sygros Hosptial-University of Athen
Athens, , Greece
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli, Campania, Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padua, Veneto, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, , Italy
Ospedale San Salvatore
L’Aquila, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Fondazione Policlinico Universitario A Gemelli
Roma, , Italy
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barelona, Spain
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, , Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Countries
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References
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Rischin D, Hughes BGM, Basset-Seguin N, Schadendorf D, Bowyer S, Trabelsi Messai S, Meier F, Eigentler TK, Casado Echarren V, Stein B, Beylot-Barry M, Dalac S, Dreno B, Migden MR, Hauschild A, Schmults CD, Lim AM, Yoo SY, Paccaly AJ, Papachristos A, Nguyen JH, Okoye E, Seebach F, Booth J, Lowy I, Fury MG, Guminski A. High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma. J Immunother Cancer. 2024 Mar 11;12(3):e008325. doi: 10.1136/jitc-2023-008325.
Rischin D, Khushalani NI, Schmults CD, Guminski A, Chang ALS, Lewis KD, Lim AM, Hernandez-Aya L, Hughes BGM, Schadendorf D, Hauschild A, Thai AA, Stankevich E, Booth J, Yoo SY, Li S, Chen Z, Okoye E, Chen CI, Mastey V, Sasane M, Lowy I, Fury MG, Migden MR. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. J Immunother Cancer. 2021 Aug;9(8):e002757. doi: 10.1136/jitc-2021-002757.
Paccaly AJ, Migden MR, Papadopoulos KP, Yang F, Davis JD, Rippley RK, Lowy I, Fury MG, Stankevich E, Rischin D. Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis. Adv Ther. 2021 May;38(5):2365-2378. doi: 10.1007/s12325-021-01638-5. Epub 2021 Mar 25.
Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing. J Immunother Cancer. 2020 Jun;8(1):e000775. doi: 10.1136/jitc-2020-000775.
Migden MR, Khushalani NI, Chang ALS, Lewis KD, Schmults CD, Hernandez-Aya L, Meier F, Schadendorf D, Guminski A, Hauschild A, Wong DJ, Daniels GA, Berking C, Jankovic V, Stankevich E, Booth J, Li S, Weinreich DM, Yancopoulos GD, Lowy I, Fury MG, Rischin D. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4. Epub 2020 Jan 14.
Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Summary is available on TrialSummaries.com
Other Identifiers
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2016-000105-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R2810-ONC-1540
Identifier Type: -
Identifier Source: org_study_id
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