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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03889912
• Other study ID #: R2810-ONC-1787
• Secondary ID: 2024-511440-76-0
• Status: Recruiting
• Phase: Phase 1
• Start date: April 11, 2019
• Est. completion date: October 22, 2027

Study information

• Verified date: April 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trial Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: October 22, 2027
• Est. primary completion date: August 12, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Regeneron Research Facility	Atlanta	Georgia
United States	Northeast Dermatology Associates	Beverly	Massachusetts
United States	Dermatology Associates of the Palm Beaches	Delray Beach	Florida
United States	Duke Cancer Center	Durham	North Carolina
United States	INOVA Schar Cancer Institute	Fairfax	Virginia
United States	MD Anderson Cancer Center	Houston	Texas
United States	Regeneron Research Facility	Louisville	Kentucky
United States	NYU Langone	New York	New York
United States	Medical Dermatology Specialists	Phoenix	Arizona
United States	Regeneron Research Facility	Redwood City	California
United States	Therapeutics Clinical Research	San Diego	California
United States	Regeneron Research Facility	Tampa	Florida
United States	Rochester Dermatologic Surgery	Victor	New York

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence and severity of TEAEs graded according to the NCI CTCAE v5		From the first dose up to 90 days after the last dose
Primary	The incidence and severity of injection site reactions (ISRs)		From the first dose to 90 days after the last dose
Secondary	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
Secondary	Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion		At time of surgery
Secondary	Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion		At time of surgery
Secondary	Cemiplimab concentration in serum over time		From the first dose up to 90 days after the last dose
Secondary	Incidence of anti-drug antibody (ADA) titers for cemiplimab		Up to 90 days after last dose
Secondary	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