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

NCT03889912 | Completed Phase 1 FDA Drug

• 2 other identifiers: R2810-ONC-17872024-511440-76-00
• Study Type: interventional
• Target: 97
• Locations: 3 countries
• Sites: 18

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

Keywords

CSCC; BCC

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Objective response rate (ORR) of index lesion

  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

• 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

Study Arms (1)

Cemiplimab

EXPERIMENTAL

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

Interventions

Cemiplimab 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

Also known as: REGN2810, Libtayo

Cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
• Prior treatment with other systemic immune modulating agent as defined in the protocol
• 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
• Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
• Patients with a history of solid organ transplant
• Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (18)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

Dermatology Associates of the Palm Beaches

Delray Beach, Florida, 33445, United States

Location

MetroDerm

Atlanta, Georgia, 30342, United States

Location

Northeast Dermatology Associates

Beverly, Massachusetts, 01915, United States

Location

Rochester Dermatologic Surgery, P.C.

Victor, New York, 14564, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

Radboud University Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

The Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066 CX, Netherlands

Location

University of Groningen, University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohorts A, B, D and H will enroll sequentially (not randomized). Cohort C and I for BCC will enroll in parallel with, and independently of, Cohorts A, B, D and H for CSCC patients

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 26, 2019
• Study Start: April 11, 2019
• Primary Completion: November 13, 2025
• Study Completion: December 10, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

NL (5); AU (4); US (9)