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Immunotherapy and Chemotherapy for Advanced Nasal Cavity/Paranasal Sinus Cancer

This study is testing a new treatment combination for advanced squamous cell carcinoma (a type of cancer) in the nasal cavity or paranasal sinuses. It combines an immunotherapy drug called pembrolizumab with chemotherapy drugs (docetaxel, and either cisplatin or carboplatin). The goal is to see if this combination increases the number of patients whose cancer shrinks or disappears (overall response rate) compared to chemotherapy alone. You may be eligible if you are at least 18 years old, have newly diagnosed, untreated Stage II-IVb nasal cavity/paranasal sinus squamous cell carcinoma, and meet other health criteria. The study will also look at how safe the treatment is and how long patients live without their cancer growing. Researchers are also studying specific markers (biomarkers) like PD-1 and PD-L1 in tumors and blood to understand how they relate to treatment success.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll 35 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, overall response rate, is measured through study completion, an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05027633

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~35 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:PembrolizumabDocetaxelCisplatinCarboplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To increase overall response rate (ORR)
Measured over through study completion, an average of 1 year

Conditions

Squamous Cell Carcinoma
the Nasal Cavity
Paranasal Sinuses

Explore related trials

Nasal Cavity Squamous Cell CarcinomaParanasal Sinus Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Renata Ferrarotto · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Renata Ferrarotto
[email protected]
(713) 745-6774
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male/female participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and/or cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.
Male participants:
Female participants:
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Have measurable disease based on RECIST 1.1.
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.

Exclusion

A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Patients must not have received prior systemic anti-cancer therapy including investigational agents or radiation therapy for PNS SCC but could have received treatment for prior cancers if greater than 2 years (refer to Item 8 for further details).

What this trial measures

  • To increase overall response rate (ORR)through study completion, an average of 1 year