Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: cemiplimab

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia
      • The Canberra Hospital
  • New South Wales
    • Gosford, New South Wales, Australia
      • Gosford Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Waratah, New South Wales, Australia
      • Calvary Mater Newcastle
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane & Women's Hospital
    • Woolloongabba, Queensland, Australia
      • Princess Alexandra Hospital
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Adelaide Cancer Centre
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
    • Wodonga, Victoria, Australia
      • Border Medical Oncology
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Brazil
  • Curitiba, Brazil
    • Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
  • Ipatinga, Brazil
    • Fundação São Francisco Xavier-Hospital Márcio Cunha
  • Lages, Brazil
    • ANIMI
  • Sao Paulo, Brazil
    • Instituto do Cancer do Estado de São Paulo ICESP
  • São Paulo, Brazil
    • Fundação Antônio Prudente - AC Camargo Câncer Center
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clínicas de Porto Alegre
• France
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Bordeaux, France, 33000
    • Hôpital Saint-André
  • Dijon, France, 21079
    • Chu Dijon Bourgogne
  • Grenoble, France, 38043
    • Chru Grenoble
  • Marseille, France, 13009
    • Hopitaux de La Timone
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire De Nantes
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75475
    • Hopital Saint Louis
  • Pierre Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Villejuif, France, 94085
    • Institut Gustave Roussy
  • Nord
    • Lille, Nord, France, 59037
      • Hopital Claude Huriez
• Germany
  • Berlin, Germany, 10117
    • Charite Campus Mitte
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Universitatsklinikum Tubingen
  • Bayern
    • Munich, Bayern, Germany, 80337
      • LMU Klinikum der Universität München
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitätsklinikum Essen
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitatsklinikum Carl Gustav Carus
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein
• Greece
  • Athens, Greece, 16121
    • Andreas Sygros Hosptial-University of Athen
• Italy
  • Brescia, Italy
    • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
  • L'Aquila, Italy
    • Ospedale San Salvatore
  • Milan, Italy
    • Istituto Europeo Di Oncologia
  • Roma, Italy
    • Fondazione Policlinico Universitario A Gemelli
  • Campania
    • Napoli, Campania, Italy
      • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
  • Veneto
    • Padova, Veneto, Italy
      • Istituto Oncologico Veneto - I.R.C.C.S.
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08916
    • Hospital Universitario Germans Trias i Pujol
  • Cordoba, Spain, 14004
    • C.H. Regional Reina Sofia - PPDS
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Valencia, Spain, 46009
    • Fundacion Instituto Valenciano de Oncologia
  • Barelona
    • L'Hospitalet de Llobregat, Barelona, Spain, 08908
      • ICO l'Hospitalet - Hospital Duran i Reynals
  • Cataluna
    • Barcelona, Cataluna, Spain, 08036
      • Hospital Clinic De Barcelona
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
    • Phoenix, Arizona, United States, 85004
      • University of Arizona Cancer Center
  • California
    • Duarte, California, United States, 91010
      • City of Hope Hospital
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
    • Redwood City, California, United States, 94063
      • Stanford University
    • San Diego, California, United States, 92161
      • University of California, San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Denver
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02130
      • Dana-Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • St. Louis University
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New York
    • New York, New York, United States, 10016
      • New York University
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
    • Rochester, New York, United States, 14623
      • University of Rochester Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18015
      • St. Luke's Hematology Oncology Specialists
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Dermatology and Laser Center of Charleston
  • Texas
    • Houston, Texas, United States, 77030
      • Md Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: cemiplimab; Other Names: REGN2810; Libtayo
Experimental: 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).	Drug: cemiplimab; Other Names: REGN2810; Libtayo
Experimental: 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).	Drug: cemiplimab; Other Names: REGN2810; Libtayo
Experimental: 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).	Drug: cemiplimab; Other Names: REGN2810; Libtayo
Experimental: 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).	Drug: cemiplimab; Other Names: REGN2810; Libtayo
Experimental: 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).	Drug: cemiplimab; Other Names: REGN2810; Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR by Investigator Assessment	ORR was defined as percentage of participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 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 mm <1 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
Duration of Response (DOR) by Independent Central Review	DOR was measured from the time measurement criteria were first met for CR/PR, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.	Up to approximately 65 months (treatment period + follow-up including survival follow-up)
DOR by Investigator Assessment	DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.	Up to approximately 65 months (treatment period + follow-up including survival follow-up)
Progression-Free Survival (PFS) by Independent Central Review	PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.	Up to approximately 65 months (treatment period + follow-up including survival follow-up)
PFS by Investigator Assessment	PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.	Up to approximately 65 months (treatment period + follow-up including survival follow-up)
Overall Survival (OS)	OS was measured from start of treatment until death due to any cause.	Up to approximately 65 months (treatment period + follow-up including survival follow-up)
Complete Response (CR) Rate by Independent Central Review	CR rate was defined as percentage of participants with BOR of CR. For participants with metastatic disease, RECIST v1.1 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 mm <1 cm. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions.	Up to 108 weeks
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score	EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.	Baseline, Up to Cycle 12 Day 1 (Week 89)
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.	Up to 108 weeks plus 105 days (5 half-lives)
Peak Concentration (Cmax) of Cemiplimab		Up to approximately 43 months
Trough Concentration (Ctrough) of Cemiplimab		Up to approximately 43 months
Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies		Up to approximately 43 months
ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays	ORR was defined as percentage of participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by immunohistochemistry (IHC). -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
DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays	DOR was measured from the time measurement criteria are first met for CR/PR, as defined in Outcome Measure 13, whichever was recorded first, until the first date of recurrent or PD or death due to any cause in participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by IHC. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.	Up to approximately 65 months (treatment period + follow-up including survival follow-up)
PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays	PFS was measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause. Expression level of PD-L1 was assessed in tumor biopsy samples. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.	Up to approximately 65 months (treatment period + follow-up including survival follow-up)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• A Plain Language Summary is available on TrialSummaries.com

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2016
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimated): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Metastatic CSCC; Unresectable locally advanced CSCC
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1540; 2016-000105-36 (EudraCT Number)

Drug and device information, study documents

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