Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Trial ID or NCT#

NCT02760498

Status

not recruiting iconNOT RECRUITING

Purpose

Groups 1 to 4 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 Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic \[nodal or distant\] or locally advanced treated with cemiplimab

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. Key
Exclusion Criteria:
  1. * 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
    1. Other protocol-defined inclusion/exclusion criteria apply
View All Criteria
Show Less

Investigator(s)

Anne Lynn S. Chang, MD
Anne Lynn S. Chang, MD
Dermatologist, General dermatologist, Dermatologic oncologist, Cutaneous oncology specialist
Professor of Dermatology
A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov