Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2021-07-12
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with recurrent CSCC.

The secondary objectives of this study are:

• To describe the objective response rate (ORR) in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC, according to modified World Health Organization (WHO) criteria

• To describe the pathologic complete response (CR) rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC

• To describe the major pathologic response rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC

• To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with recurrent CSCC

• To assess the immunogenicity of cemiplimab in patients with recurrent CSCC

• To establish a recommended dose of intralesional cemiplimab for further study in patients with recurrent CSCC

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Cemiplimab

Criteria

Key Inclusion Criteria

• History of recurrent resectable CSCC that satisfies conditions as defined in the protocol

• Patient must have measurable disease in the index lesion, as defined by modified WHO criteria. Measurable disease is defined as at least one lesion that is at least 1 cm in both of the longest perpendicular diameters.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key Exclusion Criteria

• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs)

• 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. Patients with history of metastatic CSCC (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

Note: Other protocol defined Inclusion/Exclusion criteria apply.