Preoperative Immunotherapy for Patients with Head and Neck Squamous Cell Carcinoma

Sponsor: Alain Algazi

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03708224

Provider View

This clinical trial is exploring the effects of using immunotherapy drugs before surgery in patients with advanced squamous cell carcinoma of the head and neck. The study aims to see how these treatments affect immune cells in the tumor and surgical outcomes.

Patient Parameters

Program Overview

The study is investigating how the immunotherapy drug atezolizumab, alone or combined with other immune-boosting drugs, affects immune cells in tumors of patients with advanced squamous cell carcinoma of the head and neck. Researchers want to see if this pre-surgery treatment can improve surgical results. The trial will also look at how these treatments change immune responses in the body and their safety. Additionally, the study will explore how these treatments affect the gut microbiome and certain blood markers related to inflammation and cancer.

Description

This study is testing the effects of the immunotherapy drug atezolizumab, given before surgery, on patients with advanced squamous cell carcinoma of the head and neck. The study has several parts:

  • Primary Goals:

    • To see how atezolizumab, alone or with other drugs like tiragolumab or tocilizumab, affects immune cells in the tumor.
    • To evaluate how this treatment impacts surgical outcomes.

  • Secondary Goals:

    • To observe changes in immune cell types and other immune responses caused by the treatment.
    • To assess the safety of these treatments when given before surgery.

  • Exploratory Goals:

    • To study changes in gut bacteria related to the treatment.
    • To examine the relationship between disease status and certain blood markers.
    • To explore if this treatment improves survival without cancer returning for two years.

Study Design:

  • This is a phase II trial with multiple treatment groups.
  • Patients will receive atezolizumab alone or with other drugs before surgery.
  • After surgery, patients will be monitored at various intervals to assess their health and treatment effects.

Treatment Arms:

  • Arm A: Patients receive atezolizumab before surgery and possibly after surgery if certain conditions are met.
  • Arm B: Patients receive atezolizumab and tiragolumab before surgery.
  • Arm C: Patients receive atezolizumab and tocilizumab before surgery.

Patients will be followed up after surgery at 30 days, 3 months, 6 months, 12 months, and 24 months to monitor their progress.

Eligibility Criteria

Inclusion Criteria

  • Must have a type of head and neck cancer that can be surgically removed.
  • Must be 18 years or older.
  • Must agree to provide a tumor sample for research.
  • Must be in good general health with specific blood test results within normal ranges.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception and not donate sperm during the study.

Exclusion Criteria

  • Currently participating in another study or have recently received certain treatments.
  • Have a weakened immune system or are taking medications that suppress the immune system.
  • Have active infections like tuberculosis or Epstein-Barr virus.
  • Have allergies to the study drugs.
  • Have other active cancers or autoimmune diseases requiring treatment.
  • Have certain lung or heart conditions.
  • Are pregnant or breastfeeding.
  • Have received certain vaccines recently.
  • Have a history of severe allergic reactions to similar drugs.

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