Immunotherapy with Chemotherapy and Radiation for Advanced Squamous Cancer of the Nasal Cavity and Sinuses (I-NAPA)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05027633

Provider View

This study is testing a combination of immunotherapy and chemotherapy drugs, along with radiation, to treat advanced squamous cell cancer in the nasal cavity and sinuses. The goal is to see if this approach can improve treatment outcomes compared to chemotherapy alone.

Patient Parameters

Program Overview

This clinical trial is a Phase II study focusing on a treatment combination for patients with advanced squamous cell carcinoma of the nasal cavity and paranasal sinuses. The treatment includes pembrolizumab, docetaxel, and either cisplatin or carboplatin. The study aims to evaluate the effectiveness of this combination in improving response rates and other outcomes compared to historical data with chemotherapy alone.

Description

The main goal of this study is to increase the overall response rate of the cancer treatment from 60% to 80% by using pembrolizumab with chemotherapy before radiation.

Secondary goals include:

  • Improving outcomes like progression-free survival, overall survival, and organ preservation compared to past results with chemotherapy alone.
  • Assessing the safety and tolerability of the treatment combination.
  • Examining how the immune system's response in tumors and blood relates to treatment success, focusing on T cell activity and PD-L1 status.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 or older with a new diagnosis of advanced squamous cell cancer in the nasal cavity or sinuses.
  • Men must agree to use contraception during treatment and for 150 days after the last dose.
  • Women must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
  • Participants must provide written consent to join the study.
  • Must have measurable cancer based on specific medical criteria.
  • Must provide a tumor sample for analysis, preferably a new biopsy.
  • Must be in good general health with an ECOG performance status of 0 or 1 and have adequate organ function.

Exclusion Criteria

  • Women who are pregnant or have a positive pregnancy test before treatment.
  • Anyone who has previously received certain types of immunotherapy targeting PD-1, PD-L1, or similar receptors.
  • Anyone who has had prior systemic anti-cancer therapy or radiation for this type of cancer, unless it was for a different cancer more than two years ago.

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