For Healthcare Professionals

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. At least 1 measurable lesion
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  3. Adequate bone marrow function
  4. Adequate renal function
  5. Adequate hepatic function
  6. Archived or newly obtained tumor material
  7. Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4, and 6)
  8. Surgical or radiological treatment of lesions contraindicated 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
  2. Prior treatment with an agent that blocks the PD-1/PD-L1pathway
  3. Prior treatment with a BRAF inhibitor
  4. 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.
  5. Untreated brain metastasis(es) that may be considered active
  6. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
  7. Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
  8. History of non-infectious pneumonitis within the last 5 years
  9. Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
  10. Known allergy to doxycycline or tetracycline
  11. Patients with a history of solid organ transplant
  12. 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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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
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Study’s details


Contition

Advanced Cutaneous Squamous Cell Carcinoma

Age (in years)

18 - 200

Phase

Phase 2

Participants needed

432

Est. Completion Date

Oct 2023

Treatment type

Interventional


Sponsor

Regeneron Pharmaceuticals

ClinicalTrials.gov identifier

NCT02760498

Study number

R2810-ONC-1540

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