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

NCT ID: NCT03889912

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2025-12-10

Brief Summary

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

Conditions

Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

REGN2810; Libtayo

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Medical Dermatology Specialists

Phoenix, Arizona, United States

TCR Medical Corporation

San Diego, California, United States

Dermatology Associates of the Palm Beaches

Delray Beach, Florida, United States

MetroDerm

Atlanta, Georgia, United States

Northeast Dermatology Associates

Beverly, Massachusetts, United States

Rochester Dermatologic Surgery, P.C.

Victor, New York, United States

Duke Cancer Center

Durham, North Carolina, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Alfred Health

Melbourne, Victoria, Australia

Fremantle Dermatology

Fremantle, Western Australia, Australia

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

The Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

University of Groningen, University Medical Centre Groningen

Groningen, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Countries

United States; Australia; Netherlands

Other Identifiers

2024-511440-76-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

R2810-ONC-1787

Identifier Type: -

Identifier Source: org_study_id