Study on Pre-Surgery Treatment with Nivolumab and BMS-986253 for Head and Neck Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04848116

Provider View

This clinical trial is testing the safety and feasibility of using nivolumab, combined with another drug called BMS-986253, before surgery in patients with head and neck squamous cell carcinoma. The study aims to see if this combination can be safely administered to patients who are scheduled for surgery.

Patient Parameters

Program Overview

The main goal of this study is to evaluate if using nivolumab, an immunotherapy drug, together with BMS-986253, which targets specific immune cells, is safe and feasible for patients with head and neck squamous cell carcinoma (SCCHN) who are planning to undergo surgery. This treatment is given before the surgery to see if it can help manage the cancer more effectively.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma in the head and neck area, including oral cavity, throat, or voice box. Cancer of unknown origin in neck lymph nodes can be included if tested for HPV.
  • Must be HPV negative or, if HPV positive, have a high risk due to a history of heavy smoking (20 or more pack years).
  • Must be considered suitable for surgery by a team of specialists.
  • Must have at least one tumor that can be biopsied.
  • Patients with cancer that has spread (metastatic) are allowed if surgery is needed for local disease and life expectancy is 6 months or more.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must be 18 years or older.
  • Must have a life expectancy of more than 6 months.
  • Must have normal organ and bone marrow function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception if their partners are women of childbearing potential.
  • Must understand the study and agree to sign an informed consent form.
  • Must have measurable disease to assess treatment response.

Exclusion Criteria

  • History of autoimmune diseases, except for certain stable conditions like vitiligo or type 1 diabetes.
  • Previous treatment with certain immune-targeting therapies.
  • Recent vaccination with live vaccines within 30 days before starting the study.
  • Uncontrolled brain metastases or brain metastases requiring steroids.
  • Active, uncontrolled cancer other than the one being studied.
  • Uncontrolled illnesses like severe heart conditions or infections.
  • Women who are pregnant or breastfeeding.
  • Men whose partners are not willing to use contraception.
  • Active hepatitis B or C infection.
  • Need for chronic systemic steroid or immunosuppressive treatment.
  • Epstein-Barr Virus positive head and neck cancer.
  • Patients with HIV due to unknown interactions with their treatment.

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