Study Comparing Nivolumab and Temozolomide with Temozolomide Alone in Newly Diagnosed Elderly Patients with Glioblastoma

Sponsor: University of Sydney

Sponsor score: 0

ClinicalTrials ID:NCT04195139

Provider View

This clinical trial is exploring whether adding the drug Nivolumab to the standard treatment of Temozolomide can improve survival in elderly patients newly diagnosed with glioblastoma, a type of brain cancer.

Patient Parameters

Program Overview

The study aims to find out if combining Nivolumab with Temozolomide can help elderly patients with newly diagnosed glioblastoma live longer. Glioblastoma is a severe form of brain cancer. Participants must be 65 years or older and have had surgery to confirm their diagnosis. The results will help determine the best treatment approach for these patients in the future.

Description

Participants in this study will be randomly assigned to one of two groups. One group will receive both Nivolumab and Temozolomide, while the other group will receive only Temozolomide. Nivolumab will be given through an IV infusion, starting with 240 mg on days 1 and 15 every 28 days for the first four cycles, then 480 mg on day 1 every 28 days for cycles 5 and 6. Temozolomide will be taken as tablets, with doses ranging from 150-200 mg/m2 on days 1-5 every 28 days for six cycles. Both groups will also receive standard radiotherapy treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 70 or older, or 65-69 if long course radiotherapy is not suitable, with newly diagnosed glioblastoma confirmed by surgery.
  • Tissue available for specific testing (MGMT testing).
  • ECOG performance status of 0-2, indicating full activity or some restriction in strenuous activities.
  • Life expectancy of more than 12 weeks.
  • Adequate bone marrow function, with specific blood cell counts.
  • Adequate liver and kidney function as determined by blood tests.
  • Willingness to follow all study requirements, including treatments and assessments like MRI scans.
  • Signed informed consent to participate in the study.

Exclusion Criteria

  • Certain health conditions or medications that could interfere with the study treatments.
  • Other health issues that might affect the study's results.
  • Previous chemotherapy or brain radiation within the last 5 years, except for surgery.
  • History of another cancer within the last 2 years, except for certain skin cancers or other cancers that have been disease-free for at least 2 years.
  • Significant infections like hepatitis B, C, or HIV, unless testing is needed for medical reasons.
  • Active autoimmune diseases, except for certain conditions like type I diabetes or skin disorders that don't need systemic treatment.
  • Need for high doses of steroids for symptoms related to glioblastoma or other conditions within 14 days before starting the study, except for certain inhaled or topical steroids.

Locations

FACILITYZIPCITYSTATE
Duke University Medical Center27710DurhamNorth Carolina

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