Study on Atezolizumab and Cabozantinib for Treating Recurrent Glioblastoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05039281

Provider View

This clinical trial is testing a combination of two drugs, atezolizumab and cabozantinib, to see if they can safely and effectively shrink tumors in patients with glioblastoma that has returned after treatment.

Patient Parameters

Program Overview

This study is exploring whether a combination of two drugs, atezolizumab and cabozantinib, can help control glioblastoma that has come back after previous treatment. Atezolizumab is an immunotherapy drug that may help the immune system attack cancer cells, while cabozantinib may block certain enzymes that help tumor cells grow. The trial aims to determine if these drugs can safely reduce tumor size and improve patient outcomes.

Description

The study is divided into two phases. Phase I focuses on evaluating the safety of the drug combination, while Phase II assesses how well the treatment works in preventing the cancer from getting worse over six months. Researchers will also look at overall survival rates and how long the treatment response lasts.

Participants will receive atezolizumab through an IV infusion and take cabozantinib pills daily. Treatment cycles repeat every 28 days as long as the cancer does not progress and side effects are manageable. After completing the treatment, patients will have follow-up visits to monitor their health.

The study also involves collecting blood and stool samples to analyze immune responses and gut bacteria, as well as examining tumor samples to understand the cancer better.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of glioblastoma or gliosarcoma.
  • Previously treated with radiation and temozolomide.
  • At least 12 weeks since completing initial chemoradiation.
  • Have a performance status score of 60 or higher, indicating the ability to care for oneself with some assistance.
  • At first or second recurrence of the cancer.
  • Recent brain MRI scan within 14 days before joining the study.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for five months after.
  • Men must agree to use contraception during the study and for five months after.

Exclusion Criteria

  • Have had certain types of previous cancer treatments, such as Gliadel wafers or Optune device.
  • Have received recent radiation therapy or systemic treatment with radionuclides.
  • Have ongoing complications from previous radiation therapy.
  • Participating in another therapeutic trial for recurrent cancer.
  • Have certain lung conditions or serious medical issues that interfere with study participation.
  • Have other cancers within the past five years, except for certain non-threatening types.
  • Have specific brain conditions or multifocal glioblastoma.
  • Have active infections or require systemic therapy for infections.
  • Have autoimmune diseases or conditions that could affect study results.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have a history of severe allergic reactions to similar drugs.
  • Have uncontrolled high blood pressure or heart conditions.
  • Have had recent major surgery or plan to have surgery during the study.
  • Are taking certain medications that could interfere with the study treatment.

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