Study on BALSTILIMAB for Clearing HPV in Oropharyngeal Cancer Patients

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05363709

Provider View

This clinical trial is exploring whether the drug BALSTILIMAB can help clear the HPV virus in patients with oropharyngeal cancer after their main treatment is finished. The study will also look at how this affects the long-term control of the disease.

Patient Parameters

Program Overview

The purpose of this study is to see if BALSTILIMAB, an immune therapy, can help clear the HPV virus in patients with oropharyngeal cancer who still have traces of the virus after completing their main treatment. Researchers will evaluate how well the virus is cleared and if this leads to better long-term control of the cancer.

Description

The main goal of this study is to find out if BALSTILIMAB can help clear the HPV virus from the blood in patients with oropharyngeal cancer who still have the virus after their main treatment.

Secondary goals include:

  • Checking if patients remain free of cancer for one and two years.
  • Assessing overall survival after two years.
  • Evaluating the safety and tolerability of the treatment.
  • Monitoring patient compliance and quality of life.

The study will also explore:

  • How quickly the virus clears from the mouth and blood with treatment.
  • The relationship between virus levels in the mouth and blood at different stages of treatment.
  • The link between tumor mutations and the persistence of the virus.
  • The connection between where the cancer returns and virus detection in the mouth and blood.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and agree to share personal health information.
  • Have a confirmed diagnosis of squamous cell carcinoma from the oropharynx.
  • Cancer must be at Stage I-III.
  • Must test positive for HPV or have unknown HPV status with a low smoking history.
  • Be 18 years or older.
  • Have a good performance status (ECOG 0-1).
  • Have persistent HPV in the blood after treatment.
  • Have adequate blood, liver, and kidney function for treatment.
  • Women of childbearing potential must not be pregnant or breastfeeding and must use contraception.
  • Men must use contraception if sexually active with a woman of childbearing potential.

Exclusion Criteria

  • Have previously received anti-PD-1 or anti-PD-L1 therapies.
  • Have severe or uncontrolled diseases, including high blood pressure or active infections like hepatitis or HIV.
  • Have conditions that make it difficult to follow study procedures.
  • Have active autoimmune conditions needing treatment.
  • Have current or past lung diseases like interstitial lung disease or pneumonitis.

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