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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as a single treatment for patients with stage II-IVb squamous cell carcinoma of the nasal cavity or paranasal sinuses (PNS SCC). This phase II study aims to increase the overall response rate from historical levels of 60% with chemotherapy alone to 80% when pembrolizumab is added before radiation. Secondary goals include improving progression-free survival, overall survival, organ preservation rates, and reducing local failure, while assessing treatment safety and immune markers in tumors and blood. Participants will receive pembrolizumab, docetaxel, and either cisplatin or carboplatin intravenously as induction chemotherapy combined with immunotherapy, followed by chemoradiation. This single-arm study monitors the effects of this combination throughout the treatment period. The study does not include placebo groups or blinding. During the study, patients will undergo assessments including tumor measurements based on RECIST 1.1 criteria, tumor biopsies or archival tissue collection, and evaluations of organ function and performance status. Researchers will track treatment response, survival outcomes, safety, and immune system changes over about one year. The study is sponsored by M.D. Anderson Cancer Center and includes ongoing monitoring to evaluate tolerability and effectiveness of the combined therapies.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Newly diagnosed, previously untreated stage II-IVb squamous cell carcinoma of the nasal cavity or paranasal sinuses
- Males must agree to use contraception during treatment and for 150 days after last dose, and avoid sperm donation during this time
- Females must not be pregnant or breastfeeding and must either not be of childbearing potential or agree to use contraception during treatment and for 150 days after last dose
- Signed informed consent provided
- Measurable disease based on RECIST 1.1 criteria
- Provided archival tumor tissue or newly obtained biopsy not previously irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function with blood tests within 14 days before treatment start
You will not qualify if you...
- Women of childbearing potential with a positive urine pregnancy test within 72 hours before treatment
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or agents targeting other T-cell receptors like CTLA-4, OX 40, or CD137
- Previous systemic anti-cancer therapy or radiation therapy for nasal cavity or paranasal sinus squamous cell carcinoma
- Prior cancer treatment allowed only if completed more than 2 years ago
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year until study completion
Participants receive pembrolizumab combined with induction chemotherapy followed by chemoradiation to treat advanced squamous cell carcinoma of the nasal cavity or paranasal sinuses.
Visits scheduled according to treatment cycles and chemoradiation sessions
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Renata Ferrarotto
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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