Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
