RecruitingPhase 2NCT05929664

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


Sponsor

Thomas Jefferson University

Enrollment

70 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two immunotherapy drugs — cemiplimab and fianlimab — given before surgery to people with large or locally advanced basal cell carcinoma of the head and neck that cannot be safely removed without causing major disfigurement, to see if the drugs can shrink the tumor enough for less extensive surgery. **You may be eligible if...** - You are 18 or older with locally advanced basal cell carcinoma of the head and neck - Your tumor cannot be removed without major disfigurement (e.g., significant removal of ear, nose, lip, eye, or facial nerve) - Your general health score (performance status) is 0 or 1 - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have had radiation therapy to this area in the past 6 months - You have another active cancer (with some exceptions) - You are on immune-suppressing medications or have had an organ transplant - You have a serious connective tissue disorder - You have active tuberculosis, hepatitis B, C, or HIV - You have had immunotherapy before for this cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCemiplimab

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

OTHERQuality-of-Life Assessment

Ancillary studies

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREBiopsy

Undergo biopsy

BIOLOGICALFianlimab

Fianlimab (REGN3767) administered intravenously in combination with Cemiplimab.


Locations(3)

University of Miami Health System

Miami, Florida, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT05929664


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