Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    433
  • sponsor
    Regeneron Pharmaceuticals
Updated on 28 January 2021

Summary

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.

Details
Condition Advanced Cutaneous Squamous Cell Carcinoma
Treatment REGN2810, Cemiplimab
Clinical Study IdentifierNCT02760498
SponsorRegeneron Pharmaceuticals
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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

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
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