Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07281417

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

108

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed squamous cell carcinoma of sinonasal origin
  • Primary tumor stage T3, T4a, or select T4b according to AJCC 8th edition
  • Measurable disease with at least one lesion ≥ 20 mm by chest x-ray or ≥ 10 mm by CT, MRI, or clinical exam
  • No metastatic disease outside of neck nodes; N0 or N1-3 disease allowed
  • Known HPV status prior to enrollment
  • Age 18 years or older
  • ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  • Hemoglobin ≥ 8 g/dL (may be achieved with transfusion)
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Total bilirubin ≤ 1.5 times institutional upper limit of normal
  • AST/ALT ≤ 3 times institutional upper limit of normal
  • Creatinine clearance ≥ 40 mL/min
  • HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
  • Patients with chronic hepatitis B must have undetectable viral load on therapy if needed
  • Patients with hepatitis C infection must be treated and cured or have undetectable viral load if on treatment
  • Patients with prior or concurrent malignancy not affecting safety or efficacy assessment
  • Cardiac function classified as New York Heart Association class II or better
  • Women of childbearing potential and men must use highly effective contraception during treatment and for 6 months after
  • Willingness and ability to sign informed consent
  • Insurance coverage verified for neoadjuvant chemotherapy
Not Eligible

You will not qualify if you...

  • Unresectable disease
  • T3 disease not requiring maxillectomy or orbital dissection/resection
  • Prior systemic therapy to the index lesion within 12 months, including cemiplimab or immune modulators
  • Palliative radiation therapy (<20 Gy) within 1 week prior to study entry
  • Significant autoimmune disease requiring systemic immunosuppressive treatment within 5 years
  • History of pneumonitis within 5 years
  • Unresolved adverse events greater than grade 1 from prior anti-cancer therapy except alopecia
  • Use of other investigational agents
  • Known allergy to cemiplimab, carboplatin, paclitaxel, or related compounds
  • Uncontrolled illness or conditions that increase risk for study participation
  • Pregnant women or men and women not willing to use contraception during and 6 months after treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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