Study on Immune Modulation by Abemaciclib in HPV-Negative Head and Neck Cancer (AIM Trial)

Sponsor: University of Arizona

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04169074

Provider View

This clinical trial is testing the effects of a drug called abemaciclib on patients with HPV-negative head and neck cancer. The study aims to see if the drug can reduce tumor size before surgery and understand its impact on the immune system.

Patient Parameters

Program Overview

This study is exploring the effects of a drug called abemaciclib on patients with HPV-negative head and neck squamous cell carcinoma (HNSCC) who are scheduled for surgery. The trial will last between 10 to 21 days, during which patients will receive abemaciclib before their surgery. Researchers will collect tumor samples before and after treatment to study how the drug affects the tumor and the surrounding environment. The main goal is to see if abemaciclib can reduce the size of the tumor and increase the presence of immune cells that fight cancer.

Description

This trial is designed to test the effects of abemaciclib, a cancer drug, on patients with HPV-negative head and neck cancer who are preparing for surgery. The study will last for 10 to 21 days, during which patients will take abemaciclib before their surgery. Researchers will collect tumor samples before and after the treatment to study how the drug affects the tumor and its environment. The main goal is to see if abemaciclib can reduce the size of the tumor and increase the presence of immune cells that fight cancer.

The trial will also explore how the drug works in different genetic contexts, such as tumors with specific mutations. Patients will be monitored for changes in tumor size and immune response, and the study will help develop biomarkers that can predict how well the drug works.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma in the mouth, throat, or voice box, and the cancer is HPV-negative.
  • Cancer must be at stage I to IVa and planned for surgical removal.
  • Tumors must be measurable by scans or physical examination.
  • No previous treatment for the current head and neck cancer.
  • Can have two primary tumors or tumors on both sides.
  • If previously treated for head and neck cancer, the new cancer must be at least 1 cm away and treated at least 2 years ago.
  • Good overall health with a performance status of 0 or 1.
  • Adequate blood, liver, and kidney function based on specific tests.
  • Able to swallow pills.
  • Willing to sign informed consent and agree to tumor sample collection.

Exclusion Criteria

  • Previous treatment with CDK 4/6 inhibitors or certain immune therapies.
  • Use of immunosuppressive medication within 14 days before starting the study, with some exceptions.
  • Active or past autoimmune or inflammatory disorders, with some exceptions.
  • History of certain heart or lung conditions.
  • Gastrointestinal issues that affect drug absorption.
  • Use of certain medications that affect drug metabolism.
  • Active infections requiring treatment.
  • Any condition that may affect participation or safety.
  • Pregnant or breastfeeding women.
  • Not using effective contraception during the study and for a specified time after.
  • Prisoners or those involuntarily detained.

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