Study on Ibrutinib Combined with Nivolumab or Cetuximab for Treating Recurrent or Metastatic Head and Neck Cancer

Sponsor: University of California, San Diego

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03646461

Provider View

This clinical trial is testing the effectiveness of combining Ibrutinib with either Nivolumab or Cetuximab to treat head and neck cancer that has returned or spread to other parts of the body.

Patient Parameters

Program Overview

This study aims to find out if using Ibrutinib together with either Nivolumab or Cetuximab can help treat head and neck squamous cell carcinoma (HNSCC) that has come back or spread. The trial is open-label, meaning both the researchers and participants know which treatment is being given. Participants will be randomly assigned to receive either Ibrutinib with Cetuximab or Ibrutinib with Nivolumab. The study will include adults aged 18 and older who have not been treated with EGFR inhibitors for their recurrent or metastatic cancer.

Description

This clinical trial is designed to test the combination of Ibrutinib with either Nivolumab or Cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups: one group will receive Ibrutinib with Cetuximab, and the other will receive Ibrutinib with Nivolumab. The study will evaluate how effective these combinations are in treating the cancer.

Ibrutinib is provided as capsules to be taken by mouth, while Cetuximab and Nivolumab are given as clear liquids through an IV. The study will include patients who have not previously been treated with EGFR inhibitors for their recurrent or metastatic cancer. Participants must be at least 18 years old and meet other health criteria to join the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the head and neck that cannot be cured with surgery or radiation.
  • Known HPV or p16 status for oropharyngeal or unknown primary tumors.
  • Have measurable tumors based on specific medical criteria.
  • Life expectancy of more than 12 weeks.
  • Provide a tumor sample for analysis.
  • Have adequate blood cell counts and organ function.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Women must not be pregnant and must agree to use effective contraception during and after the study.
  • Men and women must agree to use birth control during and after the study.
  • Willing to provide informed consent and follow study procedures.

Exclusion Criteria

  • Previous treatment with EGFR inhibitors for recurrent or metastatic cancer.
  • Nasopharyngeal carcinoma.
  • Active brain metastases.
  • Recent chemotherapy or immunotherapy.
  • Previous treatment with BTK, PD-1, or PD-L1 inhibitors.
  • History of other cancers unless treated and inactive for 3 years.
  • Current use of immunosuppressive therapy.
  • Recent vaccination with live vaccines.
  • Recent infection requiring treatment.
  • Unresolved side effects from previous cancer treatments.
  • Known bleeding disorders.
  • Recent stroke or brain bleeding.
  • Active HIV, hepatitis B, or hepatitis C infections.
  • Active systemic infection.
  • History of lung disease.
  • Active autoimmune disease.
  • Recent major surgery.
  • Serious medical conditions that could affect safety or study results.
  • Significant heart disease.
  • Difficulty swallowing or gastrointestinal issues.
  • Use of certain medications that affect the liver or blood clotting.
  • Pregnant or breastfeeding women.
  • Unable to participate in study procedures or understand the study.

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