NCT05027633

Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II study that will evaluate the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as single treatment modality in patients with stage II-IVb (T2-4, any N, M0) squamous cell carcinoma of the nasal cavity/paranasal sinuses (PNS SCC).

Detailed description

Primary Objective -Increase overall response rate (ORR), following pembrolizumab combined with induction chemotherapy prior to radiation, from historical 60% with induction chemotherapy alone to 80%. Secondary Objective * Improve the following efficacy endpoints relative to historical results with chemotherapy alone: progression free survival (PFS), overall survival (OS), organ \[orbital, maxillary, cranial\] preservation rate (OPR), and locoregional failure (LRF). * To determine safety and tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC. * Correlate immune phenotype in tumors and blood, including T cell infiltration and PD-L1 status, with treatment outcomes.

Conditions

• Squamous Cell Carcinoma
• the Nasal Cavity
• Paranasal Sinuses

Interventions

Type	Name	Description
DRUG	Pembrolizumab	given by IV
DRUG	Docetaxel	given by IV
DRUG	Cisplatin	given by IV
DRUG	Carboplatin	given by IV

Timeline

• Start date: 2021-11-02
• Primary completion: 2028-03-30
• Completion: 2028-03-30
• First posted: 2021-08-30
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study