Study on Adding Cemiplimab to Chemotherapy Before Surgery for Patients with Sinonasal Squamous Cell Carcinoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07281417

This clinical trial is testing whether adding the immunotherapy drug cemiplimab to standard chemotherapy before surgery can improve outcomes for patients with sinonasal squamous cell carcinoma, a type of cancer in the nasal cavity and sinuses.

Patient Parameters

Program Overview

This study is exploring if combining cemiplimab, an immunotherapy drug, with chemotherapy drugs carboplatin and paclitaxel before surgery can better control sinonasal squamous cell carcinoma compared to chemotherapy alone. The usual treatment involves surgery followed by radiation, sometimes with chemotherapy. By adding cemiplimab before surgery, researchers hope to stop the cancer from growing or spreading more effectively.

Description

The main goal of this study is to see if adding cemiplimab to chemotherapy before surgery can improve the time patients live without the cancer coming back. Researchers will compare the results of patients receiving cemiplimab with those receiving only chemotherapy. They will also look at how well the cancer responds to treatment, overall survival rates, and any side effects.

Patients will be randomly assigned to one of two groups. In the first group, patients will receive cemiplimab along with carboplatin and paclitaxel through an IV every three weeks for up to two cycles before surgery. In the second group, patients will receive only carboplatin and paclitaxel on the same schedule. After this initial treatment, patients will be evaluated and proceed to further therapy based on their response.

After surgery, patients may receive additional chemotherapy and radiation therapy to help prevent the cancer from returning. Throughout the study, patients will undergo various scans and tests to monitor their health and the cancer's response to treatment. Follow-up visits will continue for up to five years to track long-term outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of sinonasal squamous cell carcinoma.
  • Cancer must be at a specific stage (T3, T4a, or select T4b) and measurable by scans or exams.
  • No evidence of cancer spread beyond the local area, except to neck lymph nodes.
  • Must know HPV status from previous tests.
  • Age 18 or older.
  • Must have good overall health with a performance status score of 2 or less.
  • Must meet specific blood count and organ function criteria.
  • HIV-positive patients must have an undetectable viral load on treatment.
  • Hepatitis B or C patients must have controlled or cured infections.
  • Must not have other cancers that interfere with this study.
  • Must use effective birth control during and after treatment if of childbearing potential.
  • Must be able to understand and sign a consent form.
  • Must have insurance coverage for chemotherapy costs before joining the study.

Exclusion Criteria

  • Cancer that cannot be surgically removed.
  • Certain types of T3 cancer that do not require extensive surgery.
  • Previous treatment with cemiplimab or similar drugs within the past year.
  • Recent radiation therapy within one week before the study.
  • Significant autoimmune diseases requiring treatment in the past five years.
  • History of lung inflammation (pneumonitis) in the past five years.
  • Unresolved side effects from previous cancer treatments, except hair loss.
  • Currently taking other experimental drugs.
  • Allergies to cemiplimab, carboplatin, or paclitaxel.
  • Serious health conditions that make participation unsafe.
  • Pregnant women or those not willing to use birth control during and after treatment.

Locations

FACILITYZIPCITYSTATE
University of Kentucky/Markey Cancer Center40536LexingtonKentucky
Ohio State University Comprehensive Cancer Center LAO43210ColumbusOhio

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