Basal Cell Carcinoma (Regeneron Study)

Study Description

Brief Summary

The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)

The secondary objectives of this study are:

  • To describe the objective response rate (ORR) in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC, according to modified World Health Organization (WHO) criteria
  • To describe the pathologic complete response (CR) rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC
  • To describe the major pathologic response rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC
  • To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with CSCC or BCC
  • To assess the immunogenicity of cemiplimab in patients with CSCC or BCC
  • To establish a recommended dose of intralesional cemiplimab for further study in patients with CSCC or BCC

Condition or Disease

Cutaneous Squamous Cell Carcinoma

Basal Cell Carcinoma

Study Design

Study Type: Interventional (Clinical Trial)
EstimatedĀ Enrollment: 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
ActualĀ Study Start Date: April 11, 2019
EstimatedĀ Primary Completion Date: October 26, 2023
EstimatedĀ Study Completion Date: January 11, 2024

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Dose Escalation: 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 ā‰¤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 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 COVID-19 vaccination (initial series and booster) within 1 week of planned start of study medication

Note: Other protocol defined Inclusion/Exclusion criteria apply.

ADDITIONAL DETAILS