Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma (NCT05039281) | Clinical Trial Compass
RecruitingPhase 1/2
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
United States6 participantsStarted 2022-09-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent form (ICF)
* Ability and willingness to comply with the requirements of the study protocol
* Age \>= 18 years
* Have histologically confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma). Archival tissue will be required for diagnosis confirmation. Receipt of archival tissue is not required for the start of treatment
* Patients must have been previously treated with radiation and temozolomide
* Patients must be at least 12 weeks out from completion of concurrent chemoradiation
* Have a performance status of \>= 60 on the Karnofsky performance status (KPS)
* Patients at either first or second recurrence will be considered eligible
* A baseline brain magnetic resonance imaging (MRI) obtained no more than 14 days prior to study enrollment
* Absolute neutrophil count (ANC) \>= 1,500 /mcL
* Platelets \>= 100,000 /mcL
* Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L
* Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN
* Creatinine clearance should be calculated per institutional standard
* Urine protein/creatinine ratio (UPCR) =\< 1 mg/mg (=\< 113.2 mg/mmol) OR 24 hour (h) urine protein =\< 1g
* Serum total bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with tota…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines two drugs — atezolizumab, an immunotherapy, and cabozantinib, a targeted therapy — that aren't typically used together for glioblastoma; can you walk me through what side effects are most likely when these two drugs are combined, and how serious they could be?
2Since this is a Phase 1/2 trial, it's still partly figuring out safety and dosing — does that mean we'd be trading some certainty about risks for a chance at a newer approach, and how does that trade-off look given where I am in my treatment?
3The trial is measuring progression-free survival and objective response rate — what would a meaningful result actually look like for someone in my situation, and how does that compare to what standard options for recurrent glioblastoma might realistically offer?
4Recurrent gliosarcoma is also included in this trial alongside glioblastoma — does my specific diagnosis affect whether this combination might be a good fit, or are the two treated the same way here?
5What would participation actually involve day-to-day — how often would I need to come in for treatment or monitoring, and is that realistic given my current health and support situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.