Study on CUE-101 and Pembrolizumab for Advanced HPV-Related Head and Neck Cancer

Sponsor: Yale University

Sponsor score: 40

ClinicalTrials ID:NCT07172256

Provider View

This clinical trial is testing the safety and effectiveness of CUE-101 alone and in combination with pembrolizumab for patients with advanced head and neck cancer linked to HPV-16. The study focuses on patients whose cancer cannot be removed by surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of CUE-101, both on its own and combined with pembrolizumab, as a treatment for patients with advanced head and neck cancer associated with HPV-16. This trial is for patients who have not received prior treatment and whose cancer cannot be surgically removed. The study will involve administering CUE-101 and pembrolizumab in different combinations to see how well they work in controlling the cancer.

Description

This study is designed to test the safety and effectiveness of CUE-101, both alone and in combination with pembrolizumab, for treating advanced head and neck cancer linked to HPV-16. Participants will receive CUE-101 and pembrolizumab in different combinations to see how well these treatments work. CUE-101 will be given at a dose of 4 mg/kg through an IV on Days 1 and 21. Pembrolizumab will be given at 200 mg through an IV on the same days. When used together, pembrolizumab will be given first, followed by CUE-101. The study aims to find out if these treatments can help control the cancer and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced head and neck cancer that cannot be removed by surgery.
  • Cancer must be linked to HPV-16 and express a specific protein called p16INK4A.
  • Must have a specific genetic marker called HLA-A*0201.
  • Must have measurable cancer that can be tracked using scans or exams.
  • Must be 18 years or older.
  • Must have good overall health and organ function.
  • HIV-positive participants must have an undetectable viral load.
  • Participants with hepatitis B or C must have controlled or treated infections.
  • Must agree to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cancer has spread to distant parts of the body or the brain.
  • Pregnant or breastfeeding women.
  • Have received prior treatment for head and neck cancer.
  • Currently participating in another clinical trial.
  • Have allergies to similar drugs or ingredients in the study medications.
  • Have a history of autoimmune diseases, except for certain conditions like vitiligo or resolved childhood eczema.
  • Have had a transplant or are taking high doses of steroids.
  • Have significant heart, lung, or gastrointestinal issues.
  • Have active infections or other serious medical conditions.
  • Have a history of substance abuse or psychiatric conditions that may affect participation.
  • Have received a live vaccine recently.
  • Have significant hearing loss or nerve damage.
  • Are unable to comply with study requirements.

Locations

FACILITYZIPCITYSTATE
Yale University06510New HavenConnecticut

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