Cemiplimab and Chemotherapy for Sinonasal Cancer

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

Recruiting Phase 2 Interventional Study
Sinonasal Squamous Cell Carcinoma Stage III Sinonasal Cancer AJCC v8 Stage IVA Sinonasal Cancer AJCC v8 Stage IVB Sinonasal Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
108 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for adults with a specific type of nose and sinus cancer. Participants will receive a combination of chemotherapy and a drug to enhance the immune response before surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with sinonasal squamous cell carcinoma.
  • I am at least 18 years old.
  • I have measurable disease.
  • I have a specific tumor stage.
  • I have a known HPV status.
  • I have good overall health (ECOG performance status ≤ 2).
  • I have certain blood test results within required limits.

You may not be able to join if

  • I have unresectable disease.
  • I have received previous treatment for my cancer in the last 12 months.
  • I have had recent radiation therapy.
  • I have a significant autoimmune disease.
  • I have had pneumonitis in the last 5 years.
  • I am currently taking another investigational drug.
  • I am pregnant or not using effective contraception.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 c…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed squamous cell carcinoma of sinonasal origin * Patients must have a T stage (T3, T4a, and select T4b) primary tumor according to American Joint Committee on Cancer (AJCC) 8th edition. Patients must have measurable disease, defined as …
Contacts

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