Study Comparing Nivolumab with Standard and Low Dose Bevacizumab for Glioblastoma

Sponsor: David Peereboom

Sponsor score: 0

ClinicalTrials ID:NCT03452579

Provider View

This clinical trial is testing two different doses of the drug bevacizumab, combined with nivolumab, to see which is more effective and safe for treating glioblastoma, a type of brain cancer. Participants will be randomly assigned to receive either the standard or low dose of bevacizumab along with nivolumab.

Patient Parameters

Program Overview

The study aims to find out how well the drug nivolumab works when combined with two different doses of bevacizumab in treating glioblastoma, a type of aggressive brain tumor. Nivolumab is an antibody that may help the immune system attack cancer cells, while bevacizumab works by cutting off the blood supply to the tumor. The study will compare the effectiveness, safety, and tolerability of these treatments in patients with recurrent glioblastoma.

Description

This study involves two groups of participants. One group will receive nivolumab and a standard dose of bevacizumab, while the other group will receive nivolumab and a lower dose of bevacizumab. The goal is to see which combination is more effective in improving survival rates and controlling the cancer. Participants will be randomly assigned to one of the two groups, and neither they nor their doctors will choose the group. The study will last over three years, including follow-up visits, depending on how the treatment affects the cancer and the participant's health.

The primary goal is to see if nivolumab with either dose of bevacizumab can improve survival rates at twelve months. Secondary goals include evaluating the safety of the treatments, comparing how long patients live without the cancer getting worse, and assessing the overall response to the treatments. The study is open-label, meaning both participants and researchers know which treatment is being given. It is designed for adults with glioblastoma that has returned after initial treatment.

Due to the COVID-19 pandemic, some in-person visits may be replaced with virtual visits, and some health checks can be done over the phone.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Willing to attend scheduled visits and follow the treatment plan.
  • Diagnosed with glioblastoma in the brain.
  • Previously treated with radiotherapy.
  • Cancer has returned, confirmed by biopsy or MRI.
  • At least 12 weeks since last radiation treatment unless new tumor growth is confirmed.
  • At least 28 days since any surgery and fully recovered.
  • Good overall health with a performance status of 70 or higher.
  • Life expectancy of more than 12 weeks.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception.
  • Men must use contraception if sexually active with women of childbearing potential.
  • Must meet specific blood and organ function criteria.
  • Must not have more than two recurrences of glioblastoma.
  • Must not have cancer spread outside the brain or significant disease in the brainstem or spinal cord.
  • Must not have serious medical conditions that could interfere with the study.
  • Must not have active autoimmune diseases requiring treatment.
  • Must not have had certain previous treatments or conditions that could affect the study results.

Exclusion Criteria

  • More than two recurrences of glioblastoma.
  • Cancer spread outside the brain or significant disease in the brainstem or spinal cord.
  • Serious medical conditions that could increase risk or interfere with the study.
  • Active autoimmune diseases requiring treatment.
  • Previous treatments with certain drugs or therapies that could affect the study.
  • Uncontrolled high blood pressure or recent severe cardiovascular issues.
  • Recent significant bleeding or clotting disorders.
  • Recent major surgery or significant injuries.
  • Unable to have an MRI due to medical conditions.
  • Positive tests for certain infections like hepatitis or HIV.
  • Severe allergies to monoclonal antibodies.
  • Need for high doses of steroids.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center44195ClevelandOhio

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