Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

To estimate the clinical benefit of REGN2810 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), as measured by overall response rate (ORR), according to central review.

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

Keywords

Advanced Cutaneous Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell REGN2810

Eligibility

For people ages 18 years and up

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
  • Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92161 United States
  • City of Hope Hospital accepting new patients
    Duarte California 91010 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT02760498
Phase
Phase 2
Study Type
Interventional
Last Updated
May 9, 2018