Study on NBTXR3 With or Without Cetuximab for Treating Locally Advanced Head and Neck Cancer

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04892173

Provider View

This clinical trial is testing a new treatment option for elderly patients with locally advanced head and neck cancer who cannot receive platinum-based chemotherapy. The study compares the effectiveness and safety of NBTXR3 combined with radiation therapy, with or without cetuximab, against radiation therapy with or without cetuximab alone.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new treatment called NBTXR3, used with radiation therapy, for elderly patients with locally advanced head and neck cancer who cannot receive platinum-based chemotherapy. The study will compare this treatment to the standard radiation therapy, with or without the drug cetuximab, to see if it offers better outcomes.

Description

This study involves two groups of participants. One group will receive NBTXR3, a new treatment injected directly into the tumor, combined with radiation therapy, with or without cetuximab. The other group will receive radiation therapy, with or without cetuximab, as chosen by the study doctor. All participants will receive a total of 70 Gy of radiation over 35 sessions in 7 weeks.

Participants will first undergo a screening process to determine eligibility, which includes confirming the type of cancer and ensuring the tumor can be injected with the treatment. After the screening, participants will be randomly assigned to one of the two treatment groups.

After completing the radiation therapy, participants will have a follow-up visit 4 weeks later. Additional follow-up visits will occur every 12 weeks for the first 2 years, and then every 24 weeks until the end of the study or other specified conditions are met. The study aims to monitor the participants' health and the effectiveness of the treatment over time.

Eligibility Criteria

Inclusion Criteria

  • Must be 65 years or older.
  • Have a confirmed diagnosis of squamous cell carcinoma in specific areas of the head and neck.
  • For those with oropharyngeal cancer, HPV p16 status must be known.
  • Tumor must be of a certain size and stage according to medical guidelines.
  • Must have a tumor that can be injected with the treatment.
  • Cannot receive platinum-based chemotherapy due to age, kidney function, hearing loss, nerve damage, or heart condition.
  • Must be able to undergo radiation therapy with the intent to cure.
  • Must have a life expectancy of at least 6 months.
  • Must have adequate organ and bone marrow function as determined by specific blood tests.

Exclusion Criteria

  • Have a type of head and neck cancer that does not meet the study's criteria.
  • Have received previous treatment for head and neck cancer.
  • Have severe allergies to cetuximab or certain lung diseases.
  • Have active HIV, hepatitis B, or hepatitis C infections.
  • Have a history of head and neck cancer that has returned after treatment.
  • Have tumors with certain characteristics that increase the risk of bleeding.
  • Have other types of cancer that could interfere with the study.
  • Have significant heart problems or heart failure.
  • Are pregnant, nursing, or not using effective birth control if of childbearing potential.
  • Are consuming areca nut (betel nut) within 6 months before the study.
  • Have any condition that the study doctor believes would not be in the participant's best interest.
  • Are participating in another clinical study.

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