Clinical Trials /

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT02760498

Description:

For Groups 1 to 4, the primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC. For Group 6, the primary objective is to provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced. Clinical benefit is measured by overall response rate (ORR) according to central review in each group.

Related Conditions:
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
  • Official Title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-1540
  • SECONDARY ID: 2016-000105-36
  • NCT ID: NCT02760498

Conditions

  • Advanced Cutaneous Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
cemiplimabREGN2810, LibtayoGroup 1

Purpose

For Groups 1 to 4, the primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC. For Group 6, the primary objective is to provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced. Clinical benefit is measured by overall response rate (ORR) according to central review in each group.

Trial Arms

NameTypeDescriptionInterventions
Group 1ExperimentalPatients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 2 weeks.
  • cemiplimab
Group 2ExperimentalPatients with unresectable locally advanced CSCC. Cemiplimab administered intravenously every 2 weeks.
  • cemiplimab
Group 3ExperimentalPatients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 3 weeks.
  • cemiplimab
Group 4ExperimentalPatients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered intravenously every 4 weeks.
  • cemiplimab
Group 6ExperimentalPatients with advanced CSCC (metastatic [nodal or distant] or locally advanced). Cemiplimab administered IV every 3weeks.
  • cemiplimab

Eligibility Criteria

        Key Inclusion Criteria:

          -  At least 1 measurable lesion

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

          -  Adequate bone marrow function

          -  Adequate renal function

          -  Adequate hepatic function

          -  Archived or newly obtained tumor material

          -  Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4 and 6)

          -  Surgical or radiological treatment of lesions contraindicated

        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

          -  Prior treatment with an agent that blocks the PD-1/PD-L1pathway

          -  Prior treatment with a BRAF inhibitor

          -  Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to
             the first dose of cemiplimab, or associated with immune-mediated adverse events that
             were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated
             with toxicity that resulted in discontinuation of the immune-modulating agent.
             Examples of immune-modulating agents include therapeutic vaccines, cytokine
             treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB
             (CD137), or OX-40.

          -  Untreated brain metastasis(es) that may be considered active

          -  Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
             4 weeks prior to the first dose of cemiplimab

          -  Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with
             hepatitis B virus or hepatitis C virus

          -  History of non-infectious pneumonitis within the last 5 years

          -  Allergic reactions or acute hypersensitivity reaction attributed to antibody
             treatments

          -  Known allergy to doxycycline or tetracycline

          -  Patients with a history of solid organ transplant

          -  Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or
             clinical laboratory abnormality that renders the patient unsuitable

        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:Overall Response Rate
Time Frame:30 months
Safety Issue:
Description:Groups 1, 3, 4, and 6: RECIST version 1.1 will be used to determine ORR. Group 2: Clinical response criteria will be used to determine ORR

Secondary Outcome Measures

Measure:Investigator Assessments of Overall Response Rate
Time Frame:Up to 30 months
Safety Issue:
Description:Groups 1-4 and 6
Measure:Duration of response
Time Frame:Up to 30 months
Safety Issue:
Description:Groups 1-4 and 6
Measure:PFS (progression-free survival)
Time Frame:Up to 30 months
Safety Issue:
Description:Groups 1-4 and 6
Measure:Overall Survival
Time Frame:Up to 30 months
Safety Issue:
Description:Groups 1-4 and 6
Measure:Complete Response (CR) Rate
Time Frame:Up to 30 months
Safety Issue:
Description:
Measure:Change in scores of patient reported outcomes on EORTC QLQ-C30
Time Frame:Up to 30 months
Safety Issue:
Description:
Measure:Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame:Up to 30 months
Safety Issue:
Description:
Measure:Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Cemiplimab PK: Peak concentrations (Cmax) (SC)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Cemiplimab PK: Pre-infusion concentration (Ctrough)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Cemiplimab PK: Time of end-of-infusion (teoi)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Cemiplimab PK: Time to peak concentration (tmax) (SC)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Cemiplimab PK: Absolute bioavailability after SC administration
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Anti-cemiplimab antibodies
Time Frame:Up to 30 months
Safety Issue:
Description:
Measure:Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR
Time Frame:Up to 30 months
Safety Issue:
Description:Group 6
Measure:IHC assessment of correlation between PD-L1 and DOR
Time Frame:Up to 30 months
Safety Issue:
Description:Group 6
Measure:IHC assessment of correlation between PD-L1 and PFS
Time Frame:Up to 30 months
Safety Issue:
Description:Group 6

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Metastatic CSCC
  • Unresectable locally advanced CSCC

Last Updated

January 26, 2021