Study on Ipilimumab, Nivolumab, and Radiation Therapy for Treating HPV Positive Advanced Throat Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03799445

Provider View

This clinical trial is exploring the use of two immunotherapy drugs, ipilimumab and nivolumab, combined with radiation therapy to treat patients with advanced throat cancer caused by HPV. The study aims to find the best dose and assess how well this combination works in shrinking tumors and preventing cancer from spreading.

Patient Parameters

Program Overview

This study is testing a combination of two immunotherapy drugs, ipilimumab and nivolumab, along with radiation therapy, to treat advanced throat cancer that is positive for human papillomavirus (HPV). The goal is to see if this combination can help the immune system attack cancer cells more effectively and stop them from growing and spreading. Radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. Researchers hope that using these treatments together will be more effective for patients with HPV-positive throat cancer.

Description

The main goals of this study are to determine if the combination of ipilimumab, nivolumab, and radiation therapy is safe and can be tolerated by patients, and to see how well it works in treating HPV-positive throat cancer. Researchers will also look at how well the cancer responds to this treatment after six months and track the patients' progress over two years to see if the cancer stays under control.

Secondary goals include evaluating how patients respond to the treatment after six weeks, checking for any swallowing difficulties, and monitoring any side effects reported by patients. The study will also assess how well the treatment controls the cancer locally and regionally, and track overall survival rates over one and two years.

Researchers will also study changes in the immune system and cancer environment before and after treatment, and explore how these changes relate to the treatment's effectiveness. Participants will receive nivolumab and ipilimumab through an IV, and undergo radiation therapy five days a week for six weeks. After treatment, patients will have follow-up visits to monitor their health and the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with a specific type of throat cancer (squamous cell carcinoma) in areas like the tonsils or base of the tongue.
  • Cancer must be at a certain stage and positive for HPV.
  • Must have measurable cancer at the primary site or lymph nodes.
  • Must have recent imaging tests to evaluate the cancer.
  • Must have a good performance status, meaning they are fully active or able to carry out light work.
  • Must have adequate blood counts and organ function based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Must not have active hepatitis B, hepatitis C, or HIV infections.
  • Must provide a tumor sample for testing.

Exclusion Criteria

  • Cancer in areas like the mouth, nasopharynx, or larynx, even if HPV positive.
  • Cancer of unknown origin in the neck.
  • Evidence of cancer spread beyond the neck or below the collarbones.
  • Previous complete removal of the cancer with surgery.
  • Other active cancers or previous cancers unless disease-free for at least three years.
  • Previous chemotherapy or radiation that overlaps with the study area.
  • Severe health conditions like heart failure or infections requiring hospitalization.
  • Active autoimmune diseases requiring treatment in the past two years.
  • Recent live vaccinations.
  • Pregnant or breastfeeding women.
  • Severe allergies to contrast materials used in imaging tests.

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