Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)

This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).

The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).

The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.

The study is also looking at several other research questions, including:

• What side effects may happen from taking the study drug
• To see effect of cemiplimab on the tumor
• How much study drug is in the blood at different times

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology
• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University of Groningen, University Medical Centre Groningen
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Medical Center
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Maastricht University Medical Center
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • The Netherlands Cancer Institute - Antoni van Leeuwenhoek
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists
  • California
    • San Diego, California, United States, 92123
      • TCR Medical Corporation
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Dermatology Associates of the Palm Beaches
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • MetroDerm
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Northeast Dermatology Associates
  • New York
    • Victor, New York, United States, 14564
      • Rochester Dermatologic Surgery, P.C.
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar 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

1. Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
2. Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key Exclusion Criteria

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
2. Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
3. Prior treatment with other systemic immune modulating agent as defined in the protocol
4. M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
5. Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
6. Patients with a history of solid organ transplant
7. Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication

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; Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B. Note: Cohort E through G will not be opened for participation.	Drug: Cemiplimab; Each patient will receive intralesional injections of cemiplimab every week (QW), or at less frequent dosing into the lesion at the assigned dose level for 3-12 weeks prior to scheduled surgery; Other Names: REGN2810; Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5	Dose levels 1-3	From the first dose through day 28
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5	Dose levels 1-3	From the first dose to 90 days after the last dose
Incidence and severity of TEAEs graded according to the NCI CTCAE v5		From the first dose up to 90 days after the last dose
The incidence and severity of injection site reactions (ISRs)		From the first dose to 90 days after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cemiplimab concentration in serum over time		From the first dose up to 90 days after the last dose
Incidence of anti-drug antibody (ADA) titers for cemiplimab		Up to 90 days after last dose
Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations	The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.	Up to 90 days after last dose
Objective response rate (ORR) of index lesion	Determined by the investigator using the modified World Health Organization (WHO) criteria	At baseline and at Week 13
Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion		At time of surgery
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion		At time of surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): November 13, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: BCC; CSCC
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Basal Cell; Carcinoma, Basal Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; cemiplimab
• Other Study ID Numbers: R2810-ONC-1787; 2024-511440-76-00 (Registry Identifier: EU CT Number)

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