Testing the Combination of Anti-cancer Drugs Tiragolumab and Atezolizumab to Improve Outcomes for Patients With Recurrent Glioblastoma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06328036
Phase
PHASE2
Status
Withdrawn

Conditions

  • Recurrent Glioblastoma, IDH-Wildtype

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Surgical Procedure — PROCEDURE
    Undergo surgical resection
  • Tiragolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial compares the safety, side effects and effectiveness of atezolizumab with tiragolumab to atezolizumab alone in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Glioblastoma is the most common primary brain cancer in adults and despite aggressive treatment, it is nearly always fatal. Currently, there are limited effective treatment options in patients that have recurrence. Immunotherapy has been shown to be effective in other types of cancer and may be an appealing potential treatment option for recurrent glioblastoma. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Study doctors also want to learn if a tumor infiltrating T lymphocyte (TIL) response is helpful to determine the benefit of the combination of study drugs compared to the usual approach. TILs are a type of immune cell that has moved from the blood into a tumor. TILs can recognize and kill tumor cells. Giving atezolizumab with tiragolumab may be safe, tolerable and/or effective compared to atezolizumab alone in treating patients with recurrent glioblastoma.

Key Dates

Start date
Apr 30, 2025
Status verified
Dec 2024
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GROUP A (neoadjuvant atezolizumab, tiragolumab)
    Patients receive atezolizumab IV over 60 minutes and tiragolumab IV over 20-75 minutes and 14-19 days later, undergo surgical resection. Following surgery, patients may receive tiragolumab IV and atezolizumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI at baseline, 24-72 hours after surgery, then every 9 weeks until progression and blood sample collection throughout the study.
  • Experimental: GROUP B (neoadjuvant tiragolumab)
    Patients receive tiragolumab IV over 20-75 minutes and 14-19 days later, undergo surgical resection. Following surgery, patients may receive tiragolumab IV and atezolizumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI at baseline, 24-72 hours after surgery, then every 9 weeks until progression and blood sample collection throughout the study.
  • Experimental: GROUP C (neoadjuvant atezolizumab)
    Patients receive atezolizumab IV over 60 minutes and 14-19 days later, undergo surgical resection. Following surgery patients may receive atezolizumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI at baseline, 24-72 hours after surgery, then every 9 weeks until progression and blood sample collection throughout the study.
  • Active Comparator: GROUP D (no neoadjuvant drug)
    Patients undergo surgical resection on study. Following surgery patients may receive atezolizumab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI at baseline, 24-72 hours after surgery, then every 9 weeks until progression and blood sample collection throughout the study.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Up to 36 months ]

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