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Clinical Trial 20299

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03889912

Phase: Phase I
Prinicipal Investigator:

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Overview

Study Title

A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810) Administered Intralesionally, for Patients with Recurrent Cutaneous Squamous Cell Carcinoma (CSCC)

Summary

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

Objective

The primary objective is to characterize the safety and tolerability of cemiplimab (also known as REGEN2810) injected intralesionally in patients with recurrent cutaneous squamous cell carcinoma (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 CSCC.

Treatments

Therapies

Medications

Inclusion Criteria

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

  • 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.
  • Participants with a history of solid organ transplant
  • Note: Other protocol defined Inclusion/Exclusion criteria apply.

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