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

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.

Conditions

• Sinonasal Squamous Cell Carcinoma
• Stage III Sinonasal Cancer AJCC v8
• Stage IVA Sinonasal Cancer AJCC v8
• Stage IVB Sinonasal Cancer AJCC v8

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Carboplatin

Given IV

DRUG

Carboplatin

Given carboplatin

BIOLOGICAL

Cemiplimab

Given IV

OTHER

Chemoradiotherapy

Undergo SOC CRT

DRUG

Cisplatin

Given cisplatin

PROCEDURE

Computed Tomography

Undergo PET/CT and CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Surgical Procedure

Undergo surgery

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Siddharth Sheth · Ohio State University Comprehensive Cancer Center LAO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-11-24

Primary Completion

2030-12-16

Completion

2030-12-16

FDA Drug

Yes

Countries

• United States

Study Locations