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Advanced Cutaneous Squamous Cell CarcinomaPhase 2NCT02760498

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

A Phase 2 study testing cemiplimab in people with Advanced Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 78 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
78 sitesin 8 countries
Study dates
7 Apr 2016to 18 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

78 sites in 8 countries.

78 sites in 8 countries

United States26 sites

  • University of Colorado, Denver

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02130

  • Dermatology and Laser Center of Charleston

    Charleston, South Carolina, 29407

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope Hospital

    Duarte, California, 91010

  • St. Luke's Hematology Oncology Specialists

    Easton, Pennsylvania, 18015

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • New York University

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Arizona Cancer Center

    Phoenix, Arizona, 85004

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Stanford University

    Redwood City, California, 94063

  • University of Rochester Medical Center

    Rochester, New York, 14623

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California, San Diego

    San Diego, California, 92161

  • St. Louis University

    St Louis, Missouri, 63104

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

France11 sites

  • Hopital Avicenne

    Bobigny, 93000

  • Hôpital Saint-André

    Bordeaux, 33000

  • CHU Dijon Bourgogne

    Dijon, 21079

  • CHRU Grenoble

    Grenoble, 38043

  • Hôpital Claude Huriez

    Lille, Nord, 59037

  • Hopitaux de La Timone

    Marseille, 13009

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Hopital Cochin

    Paris, 75014

  • Hôpital Saint Louis

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Institut Gustave Roussy

    Villejuif, 94085

Other trials in France

Australia10 sites

  • The Canberra Hospital

    Garran, Australian Capital Territory

  • Gosford Hospital

    Gosford, New South Wales

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Calvary Mater Newcastle

    Waratah, New South Wales

  • Border Medical Oncology

    Wodonga, Victoria

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

Other trials in Australia

Spain10 sites

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barelona, 08908

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Fundacion Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

Germany8 sites

  • Charitè Campus Mitte

    Berlin, 10117

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • SRH Wald-Klinikum Gera

    Gera, 07548

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitatsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • LMU Klinikum der Universität München

    Munich, Bavaria, 80337

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Brazil6 sites

  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

    Curitiba

  • Fundação São Francisco Xavier-Hospital Márcio Cunha

    Ipatinga

  • Animi

    Lages

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Fundação Antônio Prudente - AC Camargo Câncer Center

    São Paulo

  • Instituto do Cancer do Estado de São Paulo ICESP

    São Paulo

Other trials in Brazil

Italy6 sites

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

    Brescia

  • Ospedale San Salvatore

    L’Aquila

  • Istituto Europeo Di Oncologia

    Milan

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

    Naples, Campania

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

    Padova, Veneto

  • Fondazione Policlinico Universitario A Gemelli

    Roma

Other trials in Italy

Greece1 site

  • Andreas Sygros Hosptial-University of Athen

    Athens, 16121

Other trials in Greece

About this study

Official title: 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.

Being tested
cemiplimab
Keywords
Metastatic CSCC, Unresectable locally advanced CSCC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02760498
Study groupRoleWhat they receive
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2WExperimentalParticipants 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).
Receives: Drug: cemiplimab
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2WExperimentalParticipants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Receives: Drug: cemiplimab
Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3WExperimentalParticipants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Receives: Drug: cemiplimab
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4WExperimentalParticipants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
Receives: Drug: cemiplimab
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3WExperimentalParticipants 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).
Receives: Drug: cemiplimab
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3WExperimentalParticipants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
Receives: Drug: cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 108 weeks

Secondary outcomes (15)

  1. 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.

    Measured: Up to 108 weeks

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. Overall Survival (OS)

    OS was measured from start of treatment until death due to any cause.

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

  7. 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.

    Measured: Up to 108 weeks

  8. 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.

    Measured: Baseline, Up to Cycle 12 Day 1 (Week 89)

  9. 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.

    Measured: Up to 108 weeks plus 105 days (5 half-lives)

  10. Peak Concentration (Cmax) of Cemiplimab

    Measured: Up to approximately 43 months

  11. Trough Concentration (Ctrough) of Cemiplimab

    Measured: Up to approximately 43 months

  12. Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies

    Measured: Up to approximately 43 months

  13. 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.

    Measured: Up to 108 weeks

  14. 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.

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

  15. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study start7 Apr 2016
  3. Primary completion18 Oct 2023
  4. Study completion18 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760498
Sponsor's protocol ID
R2810-ONC-1540
Other IDs
2016-000105-36, 2016
Status last verified
May 2025
First submitted
8 Apr 2016
Last updated
28 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hughes BGM, Guminski A, Bowyer S, Migden MR, Schmults CD, Khushalani NI, Chang ALS, Grob JJ, Lewis KD, Ansstas G, Day F, Ladwa R, Stein BN, Munoz Couselo E, Meier F, Hauschild A, Schadendorf D, Basset-Seguin N, Modi B, Dalac-Rat S, Dunn LA, Flatz L, Mortier L, Guegan S, Heinzerling LM, Mehnert JM, Trabelsi S, Soria-Rivas A, Stratigos AJ, Ulrich C, Wong DJ, Beylot-Barry M, Bossi P, Buges Sanchez C, Chandra S, Robert C, Russell JS, Silk AW, Booth J, Yoo SY, Seebach F, Lowy I, Fury MG, Rischin D. A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6. J Am Acad Dermatol. 2025 Jan;92(1):68-77. doi: 10.1016/j.jaad.2024.06.108. Epub 2024 Sep 7.

    PubMed 39245360

  • 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.

    PubMed 38471711

  • 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.

    PubMed 34413166

  • 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.

    PubMed 33768419

  • 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.

    PubMed 32554615

  • 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.

    PubMed 31952975

  • 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.

    PubMed 29863979

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cemiplimab in people with Advanced Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals at 78 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, France, Australia, Spain, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) by Independent Central Review (time frame: Up to 108 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760498, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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