Phase II Study of Nivolumab Injections for High-Risk Oral Premalignant Lesions

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06561087

Provider View

This clinical trial is testing whether injections of the drug nivolumab can help prevent oral cancer in patients with high-risk oral premalignant lesions.

Patient Parameters

Program Overview

The study aims to find out if injecting nivolumab directly into high-risk oral premalignant lesions can help prevent the development of oral cancer. Researchers will also look at how well the lesions respond to the treatment and if they completely disappear after the injections.

Description

This study is focused on patients with high-risk oral premalignant lesions, which are areas in the mouth that could potentially develop into cancer. The main goal is to see if injecting nivolumab directly into these lesions can help prevent oral cancer. Researchers will monitor how long patients remain free from oral cancer after receiving the treatment. They will also evaluate how well the lesions respond to the treatment, including whether they shrink or disappear completely. The study will follow specific criteria to measure these responses and ensure the safety and effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a visible, biopsy-confirmed premalignant lesion inside the mouth that has not been treated before.
  • Be willing and able to sign a consent form to participate in the study.
  • Be 18 years or older.
  • Agree to provide a tissue sample from the lesion, either from a previous biopsy or a new one.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have adequate organ function based on specific medical tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the treatment and agree to use two methods of birth control or be surgically sterile or abstain from heterosexual activity during the study and for 120 days after the last dose of nivolumab.
  • Men must agree to use effective contraception during the study and for 120 days after the last dose of nivolumab.

Exclusion Criteria

  • Currently participating in another study with anti-cancer treatment or have done so within the last 4 weeks.
  • Have a history of active tuberculosis (TB).
  • Allergic to nivolumab or its ingredients.
  • Have received a monoclonal antibody treatment for cancer within 4 weeks before the study or have not recovered from side effects of previous treatments.
  • Have had chemotherapy, targeted therapy, or radiation within 2 weeks before the study or have not recovered from side effects of previous treatments.
  • Have another progressing cancer that requires treatment, except for certain skin cancers or cervical cancer.
  • Have a history of lung inflammation not caused by infection.
  • Have an active infection requiring treatment.
  • Have any condition or treatment that could interfere with the study results or participation.
  • Have psychiatric or substance abuse issues that could affect participation.
  • Are pregnant, breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose of nivolumab.
  • Have received a live vaccine within 30 days before starting the study treatment. (Note: Inactivated flu vaccines are allowed, but live vaccines like Flu-Mist® are not.)

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