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

Phase 1

Recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma
• Interventions: Drug: Cemiplimab

• Registration Number: NCT03889912
• Lead Sponsor: Regeneron Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-26
• Study Start: 2019-04-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-08-12
• Study Completion: 2027-10-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cemiplimab	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.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of TEAEs graded according to the NCI CTCAE v5	From the first dose up to 90 days after the last dose
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	From the first dose through day 28	Dose levels 1-3
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	From the first dose to 90 days after the last dose	Dose levels 1-3
The incidence and severity of injection site reactions (ISRs)	From the first dose to 90 days after the last dose

Secondary Outcome Measures

Name	Time	Method
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
Objective response rate (ORR) of index lesion	At baseline and at Week 13	Determined by the investigator using the modified World Health Organization (WHO) criteria
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	Up to 90 days after last dose	The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.

Trial Locations

Locations (22)

Medical Dermatology Specialists; 🇺🇸 Phoenix, Arizona, United States

Stanford University School of Medicine; 🇺🇸 Redwood City, California, United States

TCR Medical Corporation; 🇺🇸 San Diego, California, United States

Dermatology Associates of the Palm Beaches; 🇺🇸 Delray Beach, Florida, United States

MCC - Magnolia Drive, SRB-3; 🇺🇸 Tampa, Florida, United States

MetroDerm; 🇺🇸 Atlanta, Georgia, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Northeast Dermatology Associates; 🇺🇸 Beverly, Massachusetts, United States

Dermatology Surgery Associates; 🇺🇸 New York, New York, 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, Noord-Holland, Netherlands

University of Groningen, University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands