Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review.

The secondary objectives of the study are:

• To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including:
• Major pathologic response (mPR) rate per independent central pathology review
• pCR rate and mPR rate per local pathology review
• ORR prior to surgery, according to local assessment using RECIST 1.1
• To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS)
• To evaluate the safety profile of neoadjuvant cemiplimab
• To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review
• To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Regeneron Study Site
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Regeneron Study Site
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Regeneron Study Site
• Germany
  • Dresden, Germany, 01307
    • Regeneron Study Site
  • Essen, Germany, 45147
    • Regeneron Study Site
  • Kiel, Germany, 24105
    • Regeneron Study Site
  • Tübingen, Germany, 72076
    • Regeneron Study Site
• United States
  • California
    • Palo Alto, California, United States, 94304
      • Regeneron Study Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Regeneron Study Site
  • Florida
    • Miami, Florida, United States, 33176
      • Regeneron Study Site
    • Tampa, Florida, United States, 33612
      • Regeneron Study Site
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Regeneron Study Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Regeneron Study Site
    • Boston, Massachusetts, United States, 02215
      • Regeneron Study Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Regeneron Study Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Regeneron Study Site
  • New York
    • New York, New York, United States, 10065
      • Regeneron Study Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Regeneron Study Site
    • Durham, North Carolina, United States, 27710
      • Regeneron Study Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Regeneron Study Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Regeneron Study Site
    • Houston, Texas, United States, 77030
      • Regeneron Study Site

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria

• Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
• At least 1 lesion that is measurable by RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Key Exclusion Criteria

• Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
• Distant metastatic disease (M1), visceral and/or distant nodal
• Prior radiation therapy for CSCC
• Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
• Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
• History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
• Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cemiplimab; Will receive IV infusion Q3W	Drug: Cemiplimab; Intravenous (IV) infusion every 3 weeks (Q3W); Other Names: REGN2810; Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review	Up to 12 Weeks
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review	Up to 12 weeks
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review	Up to 12 Weeks
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1	Up to 12 Weeks
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab	Up to 12 Weeks
Number of Participants With Planned and Actual Post-Surgical Management	Up to 14 Weeks
Event Free Survival (EFS)	Up to 50 Months
Disease Free Survival (DFS)	Up to 47 Months
Overall Survival (OS)	Up to 50 Months
Incidence of Adverse Events (AEs)	Up to 52 Months
Incidence of Serious Adverse Events (SAEs)	Up to 52 Months
Incidence of Deaths	Up to 52 Months
Incidence of Laboratory Abnormalities	Up to 52 Months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Kaufman HL, Seebach F, Lowy I, Yoo SY, Mathias M, Fenech K, Han H, Fury MG, Rischin D. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2022 Oct 27;387(17):1557-1568. doi: 10.1056/NEJMoa2209813. Epub 2022 Sep 12.
• Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Yoo SY, Mathias M, Han H, Seebach F, Lowy I, Fury MG, Rischin D. Neoadjuvant cemiplimab and surgery for stage II-IV cutaneous squamous-cell carcinoma: follow-up and survival outcomes of a single-arm, multicentre, phase 2 study. Lancet Oncol. 2023 Nov;24(11):1196-1205. doi: 10.1016/S1470-2045(23)00459-X. Epub 2023 Oct 21.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): November 19, 2025

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stage II; Stage III; Stage IV; CSCC; CSCC of Head/neck; CSCC of Extremity; CSCC of Trunk
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; cemiplimab
• Other Study ID Numbers: R2810-ONC-1901; 2019-003007-35 (EudraCT Number); 2022-500811-37-00 (Ctis: EU CTR-CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy

• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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