Actively Recruiting
Phase I/II Study to Evaluate the Safety and Clinical Efficacy of Atezolizumab (Anti-PD-L1) in Combination With Cabozantinib in Patients With Recurrent Glioblastoma
Led by M.D. Anderson Cancer Center · Updated on 2025-12-19
6
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining atezolizumab and cabozantinib for patients with recurrent glioblastoma or gliosarcoma. This phase I/II trial aims to see if this combination can shrink tumors and improve progression-free survival. The study also investigates how the immune system and tumor profile may change with treatment. Participants receive atezolizumab through an intravenous infusion on the first day of each 28-day cycle and take cabozantinib orally daily for 28 days. Treatment cycles continue unless the disease worsens or side effects become unacceptable. After completing treatment, patients have follow-up visits starting 30 days later, then every three months. During the study, patients undergo assessments including brain MRIs, blood tests, stool collection for microbiome analysis, and immune profiling from tumor samples. Researchers monitor tumor response, progression-free survival at six months, overall survival, and side effects for up to three years. Participant involvement includes regular clinic visits for treatment, safety monitoring, and disease evaluation throughout the study period.
CONDITIONS
Brief Title
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Ability and willingness to comply with the study protocol
- Age 18 years or older
- Histologically confirmed WHO grade IV glioma (glioblastoma or gliosarcoma)
- Previously treated with radiation and temozolomide
- At least 12 weeks since finishing concurrent chemoradiation
- Karnofsky performance status of 60 or higher
- At first or second recurrence
- Baseline brain MRI within 14 days before enrollment
- Adequate blood counts (ANC ≥ 1500/mcL, platelets ≥ 100,000/mcL, hemoglobin ≥ 9 g/dL)
- Kidney function within normal limits or creatinine clearance ≥ 60 mL/min
- Urine protein/creatinine ratio ≤ 1 mg/mg or 24-hour urine protein ≤ 1g
- Liver function tests within specified limits
- Serum albumin ≥ 2.8 g/dl
- Coagulation tests within normal limits
- Labs performed within 14 days before treatment start
- For females of childbearing potential: negative pregnancy test and agreement to use two birth control methods or abstain during study and 5 months after last dose
- For males: agreement to use contraception during study and 5 months after last dose
You will not qualify if you...
- Prior interstitial brachytherapy, implanted chemotherapy, or local injection/convection enhanced delivery treatments
- Active treatment with Optune device or recent radiation therapy for bone metastasis within 2 weeks
- Radiation therapy within 4 weeks or radionuclide systemic treatment within 6 weeks before study treatment
- Ongoing complications from prior radiation therapy
- Participation in other recurrent therapeutic trials after chemoradiation
- History of cavitating pulmonary lesions or endotracheal/endobronchial disease
- Serious medical conditions affecting 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 or active pneumonitis
- Active infections requiring systemic therapy
- Conditions or therapies that interfere with study participation
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant or breastfeeding, or planning conception during trial
- Contraindications to MRI
- Inability to comply with study procedures
- History or risk of autoimmune diseases except certain controlled conditions
- History of idiopathic pulmonary fibrosis or active pneumonitis
- Other diseases or lab abnormalities contraindicating investigational drug use
- HIV infection or active hepatitis B or C infection
- Active tuberculosis or recent severe infections
- Use of antibiotics within 2 weeks before treatment unless prophylactic
- Anticipation of major surgery within 2 weeks or minor surgery within 10 days before treatment
- Live attenuated vaccine within 4 weeks before treatment
- Concomitant chemotherapy, hormonal therapy, immunotherapy, or radiotherapy during study
- Prior treatment with anti-PD-1 or anti-PD-L1 antibodies
- Recent systemic anticancer therapy or kinase inhibitors
- Prior anti-angiogenic therapy
- Recent immunostimulatory or immunosuppressive treatments
- History of severe allergic reactions to study drugs
- Prior bone marrow or solid organ transplantation
- Recent brain hemorrhage or lesions invading major blood vessels
- Prolonged QT interval on ECG
- Inability to swallow tablets
- Uncontrolled hypertension or history of hypertensive crisis
- Heart failure NYHA grade II or greater
- Recent myocardial infarction, unstable angina, stroke, or vascular disease
- Significant history of bleeding or clotting disorders
- Recent major surgery or trauma
- History of serious gastrointestinal conditions
- Clinically significant disorders precluding safe participation
- Concomitant anticoagulation with certain agents except allowed low-dose aspirin or stable anticoagulation without bleeding complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive atezolizumab intravenously on day 1 and take cabozantinib orally daily for 28 days. Treatment cycles repeat every 28 days as long as there is no disease progression or unacceptable side effects.
1 visit per cycle (in-person) for atezolizumab infusion and daily oral cabozantinib
Duration - Up to 3 years
After completing treatment, participants are followed up to monitor health and disease status.
1 visit at 30 days post-treatment, then visits every 3 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eva Gachimova
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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