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NCT07281417 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma
A Phase 2 study of Sinonasal Squamous Cell Carcinoma and Stage III Sinonasal Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT07281417: Recruiting Phase 2 study of Sinonasal Squamous Cell Carcinoma and Stage III Sinonasal Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT07281417 is a Phase 2 study of Sinonasal Squamous Cell Carcinoma and Stage III Sinonasal Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07281417, a Phase 2 study of Sinonasal Squamous Cell Carcinoma and Stage III Sinonasal Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Progression will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1. To evaluate EFS, survival functions will be computed using the Kaplan-Meier method and compared between groups using the stratified log-rank test. Adjustment for additional covariates will be performed using Cox proportional hazards regression analysis if numbers allow.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Cemiplimab
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center LAO - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2026-11-24 |
| Est. Completion | 2030-12-16 |
| Phase | Phase 2 |
What NCT07281417 shows while recruiting
NCT07281417 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 4 conditions, with Sinonasal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT07281417 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07281417 about?
NCT07281417 is a clinical study titled "Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma". 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 b...
What is the current status of trial NCT07281417?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2026-11-24. Estimated completion is 2030-12-16.
What conditions does trial NCT07281417 study?
This clinical trial studies the following conditions: Sinonasal Squamous Cell Carcinoma, Stage III Sinonasal Cancer AJCC v8, Stage IVA Sinonasal Cancer AJCC v8, Stage IVB Sinonasal Cancer AJCC v8.
What interventions are being tested in trial NCT07281417?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Cemiplimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07281417?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07281417 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07281417's enrollment target sits among peer trials
108 640th of 2000 higher than 1,356 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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