Actively Recruiting
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
Led by M.D. Anderson Cancer Center · Updated on 2025-12-19
6
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help control the disease in patients with recurrent glioblastoma.
CONDITIONS
Official Title
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form (ICF)
- Ability and willingness to follow study requirements
- Age 18 years or older
- Histologically confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma)
- Previously treated with radiation and temozolomide
- At least 12 weeks since completion of concurrent chemoradiation
- Karnofsky performance status of 60 or more
- Eligible at first or second recurrence of disease
- Baseline brain MRI within 14 days before enrollment
- Absolute neutrophil count of at least 1,500 /mcL
- Platelet count of at least 100,000 /mcL
- Hemoglobin of at least 9 g/dL or 5.6 mmol/L
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance/GFR of at least 60 mL/min for higher creatinine
- Urine protein/creatinine ratio less than or equal to 1 mg/mg or 24-hour urine protein less than or equal to 1 g
- Total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin less than or equal to upper limit of normal
- AST and ALT less than or equal to 2.5 times upper limit of normal
- Serum albumin of at least 2.8 g/dL
- INR or PT/aPTT less than or equal to 1.3 times upper limit of normal
- Screening labs done within 14 days (+3 working days) before treatment
- Negative serum pregnancy test for females of childbearing potential within 14 days (+/- 3 working days) before enrollment
- Female subjects of childbearing potential agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for 5 months after last dose
- Male subjects agree to use adequate contraception during the study and for 5 months after last dose
You will not qualify if you...
- Prior interstitial brachytherapy, implanted chemotherapy, local injection therapies, or Gliadel wafers
- Active treatment with the Optune device
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before first dose
- Systemic radionuclide treatment within 6 weeks before first dose
- Clinically relevant ongoing complications from prior radiation
- Participation in other recurrent therapeutic trials after chemoradiation
- History of cavitating pulmonary lesions or endotracheal/endobronchial disease
- Serious medical conditions interfering with study adherence
- Other malignancies within 5 years except certain low-risk cancers
- Known leptomeningeal disease, gliomatosis cerebri, extracranial or multifocal disease
- History of interstitial lung disease, active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Conditions or therapies that interfere with participation or study results
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnant or breastfeeding or planning conception during study
- Contraindication to MRI
- Inability to comply with study procedures
- History or risk of autoimmune disease except some controlled conditions
- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or active pneumonitis
- Diseases or conditions contraindicating investigational drug use
- HIV infection or active hepatitis B or C infection (with exceptions for resolved infections)
- Active tuberculosis
- Severe infections or signs of infection within 4 weeks or 2 weeks before first dose
- Recent use of oral or IV antibiotics within 2 weeks before first dose (prophylactic use allowed)
- Anticipated major or minor surgery close to first dose without complete healing
- Recent live attenuated vaccine within 4 weeks before first dose or expected during study
- Concomitant chemotherapy, hormonal therapy, immunotherapy, or radiotherapy during study
- Prior treatment with anti-PD-1/PD-L1 agents or certain kinase inhibitors
- Treatment with systemic immunostimulatory or immunosuppressive medications within defined timeframes
- History of severe allergic reactions to study drugs
- Prior allogeneic bone marrow or solid organ transplantation
- Recent brain hemorrhage or major bleeding history
- Known lesions invading major blood vessels with exceptions
- QTcF interval greater than 500 ms on ECG
- Inability to swallow tablets
- Uncontrolled hypertension or certain cardiovascular conditions
- History of nephrotic syndrome or hypertensive crisis
- Significant vascular disease within 6 months prior to enrollment
- History of certain gastrointestinal conditions or recent abdominal surgery
- Clinically significant disorders precluding safe participation
- Concomitant anticoagulation with certain agents except allowed low-dose therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eva Gachimova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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