Testing Investigational Drugs Atezolizumab and/or Bevacizumab with or without Standard Chemotherapy for Advanced Head and Neck Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05063552

Provider View

This clinical trial is exploring different combinations of drugs, including atezolizumab and bevacizumab, with or without standard chemotherapy, to treat advanced head and neck cancers that have spread or returned after treatment.

Patient Parameters

Program Overview

This study is testing whether adding the drugs atezolizumab and/or bevacizumab to standard chemotherapy can better treat advanced head and neck cancers that have spread or come back after treatment. Atezolizumab is an immunotherapy that helps the immune system attack cancer cells, while bevacizumab stops the growth of blood vessels that feed tumors. The study compares these new combinations to the current standard treatment to see which works best.

Description

The trial is divided into two phases. In Phase II, patients are randomly assigned to one of three groups:

  • Group A receives standard chemotherapy with cetuximab.
  • Group B receives standard chemotherapy with bevacizumab.
  • Group C receives a combination of bevacizumab and atezolizumab.

In Phase III, patients are assigned to either continue with the best treatment from Phase II or the standard chemotherapy with cetuximab.

Throughout the study, patients will have regular scans and tests to monitor their cancer and overall health. Blood samples will be collected to help researchers understand how the treatments are working. After completing the study treatment, patients will have follow-up visits to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of squamous cell carcinoma of the head and neck, excluding certain types.
  • Must have measurable cancer based on specific medical criteria.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they are fully active or able to carry out light work.
  • Must have cancer that has progressed after previous treatment with an immune checkpoint inhibitor.
  • Must not have had previous antiangiogenic treatment.
  • Must not have a history of severe immune-related side effects from previous treatments.
  • Must not have certain medical conditions that increase the risk of bleeding.
  • Must not have uncontrolled high blood pressure or a history of severe blood clots.
  • Must not be taking certain medications that affect blood clotting.
  • Must have a specific level of PD-L1 expression in their cancer cells.
  • Must not have had a severe infection or active tuberculosis recently.
  • Must not have a history of severe lung inflammation requiring high doses of steroids.
  • Must not have had a solid organ or stem-cell transplant.
  • Must not be on immunosuppressive medication recently, with some exceptions.
  • Must not have an active autoimmune disease requiring treatment recently.
  • Must not have had a severe allergic reaction to similar drugs.
  • Must not have received a live vaccine recently.
  • Must not be pregnant or breastfeeding and must agree to use effective contraception.
  • Must be able to understand and sign a consent form.
  • Must meet specific blood and organ function criteria.
  • Must not have uncontrolled calcium levels.
  • Must not have untreated or unstable brain metastases.
  • Must not have uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • Must not have significant heart disease recently.
  • Must not be receiving other cancer treatments during the study.
  • Must not have had major surgery recently.
  • Must not have other medical conditions that could interfere with the study.

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