NCT05925491

Pembrolizumab in Locally Advanced Sinonasal Carcinoma

Neoadjuvant Pembrolizumab Plus Chemotherapy in Locally Advanced Sinonasal Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced sinonasal undifferentiated carcinoma (SNUC). Activity of neoadjuvant chemotherapy in locally advanced SNUC has been already demonstrated; the primary hypothesis is that the addition of pembrolizumab as neoadjuvant and adjuvant agent might confirm the results obtained with a combined treatment strategy including chemotherapy, decreasing the burden of treatment-related side effects.

Conditions

• Sinonasal Undifferentiated Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab administration in combination with chemotherapy for 3 cycles, followed by standard of care
DRUG	Cisplatin	Cisplatin 75mg/mq in combination with pembrolizumab 200 mg and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses.
DRUG	Docetaxel	Docetaxel 75 mg/mq in combination with pembrolizumab 200 mg and cisplatin 75 mg/mq every three weeks (Q3W) for 3 courses.
DRUG	Carboplatin	Carboplatin AUC 5 alternative to Cisplatin if toxicities occur.

Timeline

• Start date: 2024-12-24
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-06-29
• Last updated: 2026-04-16

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study