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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07281417
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Carboplatin — DRUG
    Given IV
  • Carboplatin — DRUG
    Given carboplatin
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Chemoradiotherapy — OTHER
    Undergo SOC CRT
  • Cisplatin — DRUG
    Given cisplatin
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Paclitaxel — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Surgical Procedure — PROCEDURE
    Undergo surgery

Study Details

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.

Key Dates

Start date
Nov 24, 2026
Status verified
May 2026
Primary completion
Dec 16, 2030
Completion
Dec 16, 2030

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (cemiplimab, carboplatin, paclitaxel)
    See Detailed Description.
  • Active Comparator: Arm 2 (carboplatin, paclitaxel)
    See Detailed Description.

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: From randomization to first occurrence of progression of disease or death, assessed up to 5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536
Site Public Contact
859-257-3379
Susanne M. Arnold (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer Center LAOColumbusOhio43210
Siddharth Sheth
[email protected]
919-843-7709
Siddharth Sheth (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kentucky/Markey Cancer Center· Lexington, KYOhio State University Comprehensive Cancer Center LAO· Columbus, OH

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