NCT05929664

Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery

Neoadjuvant REGN2810 (Cemiplimab) or REGN2810 (Cemiplimab) Plus REGN3767 (Fianlimab) in Cutaneous Basal Cell Carcinoma of the Head and Neck

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.

Detailed description

The proposed study is a phase II trial of neoadjuvant Cemiplimab (cohort 1) or Cemiplimab plus Fianlimab (cohort 2) that will target patients with advanced BCCHN who have not been previously treated with anti-PD1 checkpoint therapy for this primary lesion. Patients will be assessed by the enrolling surgeon for response to therapy every 3 weeks (before initiating the next cycle) by clinical assessment, and by imaging assessment (every 6 weeks). Patients will undergo a minimum of 2 cycles of therapy over a 6-week window prior to surgery. Patients who demonstrate clinical or RECISTv1.1 response or stable disease with regression or up to 5% growth, will go on to the next cycle of treatment. Patients who demonstrate clinical or RECISTv1.1 radiographic progression or stable disease with \>5%-20% growth will proceed directly to surgery or to other SOC therapy (after biopsies) (Fig 1). Patients who demonstrate a complete clinical response prior to at any assessment prior to completion of 6 cycles will proceed to appropriate surgery or biopsy of tumor site to ensure complete pathologic response at the time of CR. PRIMARY OBJECTIVE: I. Our primary objective is to assess treatment response of locally advanced BCC of the head and neck (BCCHN) in the neoadjuvant, presurgical setting. SECONDARY OBJECTIVES: I. To assess functional organ preservation with neoadjuvant Cemiplimab or Cemiplimab plus Fianlimab therapy. II. To assess pathologic response. III. To assess safety of neoadjuvant therapy. IV. To assess changes in quality of life. EXPLORATORY OBJECTIVE: I. To assess treatment-related changes in the immune microenvironment related to functional changes in immune cell composition.

Conditions

• Locally Advanced Basal Cell Carcinoma
• Basal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Cemiplimab	Given IV
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Biopsy	Undergo biopsy
BIOLOGICAL	Fianlimab	Fianlimab (REGN3767) administered intravenously in combination with Cemiplimab.

Timeline

• Start date: 2023-07-05
• Primary completion: 2031-07-05
• Completion: 2031-07-05
• First posted: 2023-07-03
• Last updated: 2026-03-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study