Study on IPI-549 for Patients with Locally Advanced Head and Neck Cancer

Sponsor: Ezra Cohen

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03795610

Provider View

This clinical trial is testing the experimental drug IPI-549 to see how well it works against certain types of head and neck cancers. Participants will take the drug for two weeks before surgery, and researchers will collect tumor samples to study the effects.

Patient Parameters

Program Overview

The aim of this study is to evaluate the effectiveness of the experimental drug IPI-549 in treating locally advanced head and neck cancers. IPI-549 is not yet approved by the FDA for cancer treatment. Participants will take IPI-549 for two weeks before their scheduled surgery. During this time, researchers will collect tumor samples to analyze how the drug affects the cancer and the immune system.

Description

This is a phase 2 trial for patients with locally advanced head and neck cancer who are planning to have surgery. The main goal is to see if IPI-549 can change the behavior of certain immune cells in the body, which could help fight cancer. Participants will take IPI-549, a drug that targets specific proteins in the body, for two weeks before their surgery. Researchers will collect tumor samples before starting the drug and during surgery to study the effects.

The study team believes that the drug will increase certain immune responses in the body. They will use specific criteria to measure how well the drug works.

Eligibility Criteria

Inclusion Criteria

  • Have locally advanced head and neck cancer that can be surgically removed.
  • Must be able to swallow tablets.
  • Must be able to have a core tumor biopsy.
  • Must have good organ function.

Exclusion Criteria

  • Have skin cancer or Epstein-Barr virus-related nasopharynx cancer.
  • Have major surgery planned within 4 weeks before starting the study drug.
  • Have received chemotherapy, biologic therapy, or other experimental treatments within 28 days before starting the study drug.
  • Have a history of HIV, hepatitis B, or hepatitis C infection.
  • Are currently taking long-term immunosuppressants or systemic steroids.
  • Have had surgery or digestive issues that could affect drug absorption.
  • Are pregnant or breastfeeding.
  • Have another active cancer, except for certain non-threatening types.

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