Study on NBTXR3, Radiation Therapy, and Pembrolizumab for Treating Recurrent or Metastatic Head and Neck Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04862455

Provider View

This clinical trial is exploring a new treatment combination of NBTXR3, radiation therapy, and pembrolizumab for patients with head and neck cancer that has returned or spread. The study aims to see if this combination can effectively kill cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is testing a new treatment approach for patients with head and neck squamous cell cancer that has come back or spread to other parts of the body. The treatment involves using NBTXR3, a substance that can destroy cancer cells when activated by radiation. The radiation therapy is delivered precisely to target tumors, potentially reducing side effects. Pembrolizumab, an immunotherapy drug, is also used to help the immune system attack cancer cells. The goal is to see if this combination can kill more cancer cells and improve patient outcomes.

Description

The main goal of this study is to see how well the combination of NBTXR3, radiation therapy, and pembrolizumab works in shrinking tumors in patients with recurrent or metastatic head and neck cancer. Researchers also want to understand the safety and side effects of this treatment.

Patients will receive an injection of NBTXR3 directly into the tumor. A few days later, they will start radiation therapy, which will be given every other day or daily for 1-2 weeks. At the same time, patients will receive pembrolizumab through an IV every three weeks for up to two years, as long as the cancer does not progress and side effects are manageable.

After completing the treatment, patients will have follow-up visits every six weeks for two years to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Have head and neck squamous cell cancer that has returned or spread and cannot be cured with local treatments.
  • Have at least two cancer lesions, with one being the target for NBTXR3 injection and radiation.
  • Have previously received chemotherapy or targeted therapy for advanced disease.
  • Have results from HPV testing for oropharyngeal cancer.
  • Provide a tissue sample for PD-L1 biomarker analysis.
  • Be able to receive NBTXR3 injections in up to three target lesions.
  • Be 18 years or older.
  • Have a performance status score of 0-2, indicating good overall health.
  • Meet specific blood count and organ function criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for six months after.

Exclusion Criteria

  • Have a different type of cancer that can be treated with curative intent.
  • Have had radiation to the head and neck within the last six months.
  • Have had radiation to the lung or liver target lesions.
  • Have had severe side effects from previous immunotherapy.
  • Have received other cancer treatments within four weeks before starting the study.
  • Have not recovered from previous treatment side effects to a mild level.
  • Have active brain metastases or cancer in the brain lining.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Have a history of lung or gastrointestinal issues that are unresolved.
  • Have received a live vaccine within four weeks before starting the study.
  • Have had a stem cell transplant or organ transplant.
  • Have a history of other cancers, except for certain non-threatening types.
  • Have uncontrolled illnesses or infections.
  • Be pregnant or breastfeeding.
  • Be unable or unwilling to use effective birth control during the study and for a specified period after.

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