Actively Recruiting
Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
Led by M.D. Anderson Cancer Center · Updated on 2026-03-20
35
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants at least 18 years old with newly diagnosed, untreated stage II-IVb squamous cell carcinoma of the nasal cavity or paranasal sinuses
- Male participants must agree to use contraception during treatment and for at least 150 days after last dose and avoid sperm donation during this time
- Female participants must not be pregnant, not breastfeeding, and either not of childbearing potential or agree to contraception during treatment and for at least 150 days after last dose
- Participant or legally authorized representative provides written informed consent
- Have measurable disease based on RECIST 1.1 criteria
- Provided archival tumor tissue or newly obtained biopsy of tumor lesion not previously irradiated, preferably formalin-fixed, paraffin embedded tissue blocks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function confirmed by blood tests within 14 days prior to treatment start
You will not qualify if you...
- Female participants of childbearing potential with positive urine pregnancy test within 72 hours prior to treatment
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or agents targeting T-cell receptors such as CTLA-4, OX 40, or CD137
- Previous systemic anti-cancer therapy or radiation therapy for paranasal sinus squamous cell carcinoma
- Prior cancer treatments allowed only if completed more than 2 years ago
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Renata Ferrarotto
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here