Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT02760498 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: R2810-ONC-15402016-000105-36
• Study Type: interventional
• Target: 432
• Locations: 8 countries
• Sites: 78

Brief Summary

The goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) Cutaneous Squamous Cell Carcinoma (CSCC), or unresectable locally advanced CSCC.

Conditions

Advanced Cutaneous Squamous Cell Carcinoma

Keywords

Metastatic CSCC; Unresectable locally advanced CSCC

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) by Independent Central Review

  ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.

  Up to 108 weeks

Secondary Outcomes (15)

• ORR by Investigator Assessment

  Up to 108 weeks

• Duration of Response (DOR) by Independent Central Review

  Up to approximately 65 months (treatment period + follow-up including survival follow-up)

• DOR by Investigator Assessment

  Up to approximately 65 months (treatment period + follow-up including survival follow-up)

• Progression-Free Survival (PFS) by Independent Central Review

  Up to approximately 65 months (treatment period + follow-up including survival follow-up)

• PFS by Investigator Assessment

  Up to approximately 65 months (treatment period + follow-up including survival follow-up)

Study Arms (6)

Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W

EXPERIMENTAL

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).

Drug: cemiplimab

Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W

EXPERIMENTAL

Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).

Drug: cemiplimab

Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W

EXPERIMENTAL

Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).

Drug: cemiplimab

Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W

EXPERIMENTAL

Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).

Drug: cemiplimab

Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W

EXPERIMENTAL

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).

Drug: cemiplimab

Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W

EXPERIMENTAL

Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).

Drug: cemiplimab

Interventions

cemiplimab DRUG

Also known as: REGN2810, Libtayo

Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W; Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W; Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W; Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W; Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W; Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 1 measurable lesion
• 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

You may not qualify if:

• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (78)

University of Arizona Cancer Center

Phoenix, Arizona, 85004, United States

Location

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

City of Hope Hospital

Duarte, California, 91010, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

University of California, San Diego

San Diego, California, 92161, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02130, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

New York University

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14623, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

St. Luke's Hematology Oncology Specialists

Easton, Pennsylvania, 18015, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Dermatology and Laser Center of Charleston

Charleston, South Carolina, 29407, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Location

Gosford Hospital

Gosford, New South Wales, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

Adelaide Cancer Centre

Kurralta Park, South Australia, 5037, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Border Medical Oncology

Wodonga, Victoria, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

Curitiba, Brazil

Location

Fundação São Francisco Xavier-Hospital Márcio Cunha

Ipatinga, Brazil

Location

Animi

Lages, Brazil

Location

Fundação Antônio Prudente - AC Camargo Câncer Center

São Paulo, Brazil

Location

Instituto do Cancer do Estado de São Paulo ICESP

São Paulo, Brazil

Location

Hôpital Claude Huriez

Lille, Nord, 59037, France

Location

Hopital Avicenne

Bobigny, 93000, France

Location

Hôpital Saint-André

Bordeaux, 33000, France

Location

CHU Dijon Bourgogne

Dijon, 21079, France

Location

CHRU Grenoble

Grenoble, 38043, France

Location

Hopitaux de La Timone

Marseille, 13009, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hôpital Saint Louis

Paris, 75475, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Gustave Roussy

Villejuif, 94085, France

Location

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

LMU Klinikum der Universität München

Munich, Bavaria, 80337, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charitè Campus Mitte

Berlin, 10117, Germany

Location

SRH Wald-Klinikum Gera

Gera, 07548, Germany

Location

Andreas Sygros Hosptial-University of Athen

Athens, 16121, Greece

Location

Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

Napoli, Campania, Italy

Location

Istituto Oncologico Veneto - I.R.C.C.S.

Padua, Veneto, Italy

Location

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale San Salvatore

L’Aquila, Italy

Location

Istituto Europeo Di Oncologia

Milan, Italy

Location

Fondazione Policlinico Universitario A Gemelli

Roma, Italy

Location

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barelona, 08908, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Germans Trias i Pujol

Barcelona, 08916, Spain

Location

C.H. Regional Reina Sofia - PPDS

Córdoba, 14004, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Fundacion Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Related Publications (6)

• 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.

  PMID: 38471711 DERIVED

• 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.

  PMID: 34413166 DERIVED

• 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.

  PMID: 33768419 DERIVED

• 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.

  PMID: 32554615 DERIVED

• 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.

  PMID: 31952975 DERIVED

• 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.

  PMID: 29863979 DERIVED

Related Links

• A Plain Language Summary is available on TrialSummaries.com

MeSH Terms

Interventions

cemiplimab

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: May 3, 2016
• Study Start: April 7, 2016
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: May 28, 2025
• Results First Posted: December 11, 2024

Record last verified: 2025-05

Locations

US (26); FR (11); AU (10); DE (8); BR (6); ES (10); IT (6); GR (1)