Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Advanced Cutaneous Squamous Cell Carcinoma

Treatments: Drug: cemiplimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02760498

2016-000105-36 (EudraCT Number)

R2810-ONC-1540

Details and patient eligibility

About

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

Enrollment: 432 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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432 participants in 5 patient groups

Group 1

Experimental group

Description:

Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously (IV) every 2 weeks (Q2W).

Treatment:

Drug: cemiplimab

Group 2

Experimental group

Description:

Patients with unresectable locally advanced CSCC. Cemiplimab administered IV Q2 weeks.

Treatment:

Drug: cemiplimab

Group 3

Experimental group

Description:

Patients with metastatic CSCC to distant sites or lymph nodes. Cemiplimab administered IV Q3 weeks.

Treatment:

Drug: cemiplimab

Group 4

Experimental group

Description:

Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered IV Q4 weeks.

Treatment:

Drug: cemiplimab

Group 6

Experimental group

Description:

Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) who received cemiplimab IV Q3W for at least 27 weeks without experiencing disease progression, will have the option to receive cemiplimab by subcutaneous (SC) injection Q3W (first 12 patients) or Q6W (next ≥ 6 patients) basis.

Treatment:

Drug: cemiplimab