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

The goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) Cutaneous Squamous Cell Carcinoma (CSCC), or unresectable locally advanced CSCC.

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 6 patient groups

Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W

Experimental group

Description:

Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).

Treatment:

Drug: cemiplimab

Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W

Experimental group

Description:

Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).

Treatment:

Drug: cemiplimab

Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W

Experimental group

Description:

Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).

Treatment:

Drug: cemiplimab

Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W

Experimental group

Description:

Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).

Treatment:

Drug: cemiplimab

Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W

Experimental group

Description:

Participants received a single subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).

Treatment:

Drug: cemiplimab

Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W

Experimental group

Description:

Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).

Treatment:

Drug: cemiplimab