Clinical Trials /

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT02760498

Description:

To estimate the clinical benefit of cemiplimab monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with unresectable locally advanced CSCC (Group 2), or with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] treated (Group 4) as measured by overall response rate (ORR), according to central review.

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
  • NCT ID: NCT02760498

Conditions

  • Advanced Cutaneous Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
REGN2810Group 1

Purpose

To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central review.

Trial Arms

NameTypeDescriptionInterventions
Group 1ExperimentalPatients with metastatic CSCC: to distant sites or lymph nodes
  • REGN2810
Group 2ExperimentalPatients with unresectable locally advanced CSCC
  • REGN2810

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 externally visible CSCC lesions (Group 2
             only)

          -  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 REGN2810, or associated with immune-mediated adverse events that
             were ≥ grade 1 within 90 days prior to the first dose of REGN2810, 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 REGN2810

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

          -  History of 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 may 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:During the 12 treatment cycles (96 weeks)
Safety Issue:
Description:Overall Response Rate as determined by RECIST 1.1 for Group 1 and/or assessed per composite response criteria (Group 2)

Secondary Outcome Measures

Measure:Duration of response
Time Frame:From date of treatment until date of first documented progression or date of death, assessed up to 30 months
Safety Issue:
Description:
Measure:PFS (progression-free survival)
Time Frame:From date of treatment until date of death, assessed up to 30 months
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:From date of treatment until date of death, assessed up to 30 months
Safety Issue:
Description:
Measure:Change in scores of patient reported outcomes on EORTC QLQ-C30
Time Frame:From date of treatment until date of first documented progression or date of death, assessed up to 24 months
Safety Issue:
Description:

Details

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

Last Updated

April 12, 2017