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.
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
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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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