RecruitingPhase 2NCT07281417

Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma

Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study


Sponsor

National Cancer Institute (NCI)

Enrollment

108 participants

Start Date

Nov 24, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding cemiplimab, an immunotherapy drug, to standard chemotherapy before surgery improves outcomes for patients with squamous cell carcinoma of the sinonasal cavity (cancer in the nasal passages and sinuses). **You may be eligible if...** - Your cancer has been confirmed as squamous cell carcinoma of the sinonasal area by a biopsy - Your cancer is classified as stage T3, T4a, or select T4b (meaning it has grown into nearby structures) - You have at least one measurable tumor on imaging - There is no evidence the cancer has spread to distant organs (spread to nearby neck lymph nodes is allowed) **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body beyond the neck - You do not meet the organ function or performance status requirements - You have conditions that would make immunotherapy unsafe 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

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

DRUGCarboplatin

Given IV

DRUGCarboplatin

Given carboplatin

BIOLOGICALCemiplimab

Given IV

OTHERChemoradiotherapy

Undergo SOC CRT

DRUGCisplatin

Given cisplatin

PROCEDUREComputed Tomography

Undergo PET/CT and CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGPaclitaxel

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONRadiation Therapy

Undergo radiation therapy

PROCEDURESurgical Procedure

Undergo surgery


Locations(1)

Ohio State University Comprehensive Cancer Center LAO

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07281417


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