Clinical Trials /

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

NCT03889912

Description:

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

Related Conditions:
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma
  • Official Title: A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Recurrent Cutaneous Squamous Cell Carcinoma (CSCC)

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-1787
  • NCT ID: NCT03889912

Conditions

  • Cutaneous Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
CemiplimabREGN2810, LibtayoCemiplimab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CemiplimabExperimentalThree dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion
  • Cemiplimab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Time Frame:From the first dose through day 28
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Day 85
Safety Issue:
Description:Determined by the investigator using the modified WHO criteria at the end of treatment for patients who complete planned 12-week treatment course
Measure:Pathologic complete response rate
Time Frame:At time of surgery
Safety Issue:
Description:
Measure:Major pathologic response rate
Time Frame:Up to 24 weeks
Safety Issue:
Description:
Measure:Cemiplimab concentration in serum over time
Time Frame:From the first dose up to 90 days after the last dose
Safety Issue:
Description:
Measure:Incidence of anti-drug antibody (ADA) titers for cemiplimab
Time Frame:Up to 90 days after last dose
Safety Issue:
Description:
Measure:Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
Time Frame:Up to 90 days after last dose
Safety Issue:
Description:The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Recurrent
  • CSCC

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