Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
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.
Arms & interventions
- DrugPembrolizumab
given by IV
- DrugDocetaxel
given by IV
- DrugCisplatin
given by IV
- DrugCarboplatin
given by IV
Outcome measures
Primary
To increase overall response rate (ORR)
Time frame: through study completion, an average of 1 year
Secondary
To improve the following efficacy endpoints relative to historical results with chemotherapy alone
Time frame: through study completion, an average of 1 year
To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC
Time frame: through study completion, an average of 1 year
To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC
Time frame: through study completion, an average of 1 year
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030