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

NCT05929664 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Joseph Curry, MD · Thomas Jefferson University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2031-07-05
Completion
2031-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05929664 on ClinicalTrials.gov