Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
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
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: cemiplimab
Eligibility
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 CSCC lesions (Groups 2, 4, and 6)
- 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 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.