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Atezolizumab + Cabozantinib for Glioblastoma
Study Summary
This trial is testing the safety and side effects of two drugs, atezolizumab and cabozantinib, in patients with recurrent glioblastoma. The drugs may help to shrink tumors by interfering with the ability of tumor cells to grow and spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT02008227Trial Design
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Who is running the clinical trial?
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- I haven't had radiation for bone metastasis in 2 weeks or any radiation in 4 weeks.I have multiple brain tumors that need separate treatment areas.I have a tumor affecting my digestive system or a serious digestive condition.I haven't had cancer, other than the one being studied, in the last 5 years, except for certain low-risk types.I have not had major surgery or significant injury in the last 28 days.I have had lung scarring from previous radiation treatment.I haven't taken any immune-boosting drugs in the last 6 weeks.I am a woman able to have children and agree to use 2 birth control methods or abstain from sex during the study and for 5 months after.I am mostly able to care for myself but may need occasional help.I do not have any health conditions that could interfere with the study treatment.It has been at least 12 weeks since I finished my combined chemotherapy and radiation treatment.I have been treated with radiation and temozolomide before.I had a minor surgery or biopsy (not in the brain) within the last 107 days, or I had a central line placed within the last 2 days.I am not receiving any other cancer treatments while on this study.I am 18 years old or older.I have a history of HIV or active hepatitis B or C.You need to have a certain amount of white blood cells called neutrophils in your body (ANC >= 1,500 /mcL).I am experiencing side effects from previous radiation therapy.I had a brain MRI within the last 2 weeks.My kidney function is within the normal range or slightly above.I have had cancer treatments directly in the tumor area but not Gliadel wafers or Optune device.I am currently being treated for an infection.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I have a lung condition not caused by an infection.You are unable to undergo MRI scans for medical reasons.I have or am at risk for an autoimmune disease.I have autoimmune hypothyroidism and am on a stable thyroid medication dose.I have type 1 diabetes that is well-managed with a stable insulin routine.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I don't have any upcoming surgeries and have healed from past ones.My rash covers less than 10% of my body.My condition is stable with mild steroid creams.I haven't had a severe flare-up of my condition requiring strong treatments in the past year.I have not had signs of infection in the last 2 weeks.I had hepatitis B in the past but it's not active now.I have not taken any antibiotics in the last 2 weeks.I am taking antibiotics to prevent infections.I have not received a live flu vaccine within the last 4 weeks and won't during the study.I have been treated with drugs targeting PD-1 or PD-L1.I am not taking any medications that would exclude me from the trial.I have previously been treated with medication targeting blood vessel growth in cancer.I've only had a one-time low-dose immunosuppressant medication.I haven't had any cancer treatment in the last 4 weeks.I haven't taken any kinase inhibitor medication in the last 2 weeks.I am using inhaled corticosteroids or fludrocortisone for low blood pressure or adrenal gland issues.I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.You had a bone marrow or solid organ transplant in the past.My recent brain MRI shows bleeding, but I don't have symptoms.My cancer has spread to major blood vessels, but I am still eligible.I cannot swallow pills.I have or had nephrotic syndrome.I have had a severe hypertension crisis or brain issues due to high blood pressure.I have heart failure that affects my daily activities.I have not had a stroke or TIA in the last 6 months.I haven't had significant bleeding, like coughing up or vomiting blood, in the last 3 months.I haven't had serious abdominal issues like fistulas or obstructions in the last 6 months.I haven't taken any immune-weakening medications in the last 2 weeks.I am a woman who can have children and have a recent negative pregnancy test.I haven't had any cancer other than the one I'm being treated for in the last 5 years, except for certain low-risk types or those under watchful waiting.I agree to use birth control during and for 5 months after the study.My heart's electrical activity (QTcF) is not over 500 ms.I have a history of lung scarring or inflammation.I have psoriasis and have had an eye exam to check for related eye issues.I have skin conditions like eczema or psoriasis without severe symptoms.My diagnosis is grade IV glioma, confirmed by tissue analysis.I have not had a heart attack or unstable chest pain in the last 6 months.You have read and signed a document that explains the study and your participation in it.I do not have any health issues that would prevent me from following the study's requirements.I have lung lesions with cavities or disease in my airways.I tested positive for hepatitis C but do not currently have the virus in my blood.I have active tuberculosis.My condition has returned for the first or second time.I do not have a bleeding disorder or blood clotting problem that isn't treated with medication.You have mental health or drug/alcohol addiction issues that may make it difficult for you to participate in the trial.You are willing and able to follow the study's rules and requirements.I am not in any other cancer treatment trials since finishing chemoradiation.
- Group 1: Treatment (atezolizumab, cabozantinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the primary functions of Atezolizumab?
"Atezolizumab is not only useful for small cell lung cancer patients, it can also help treat those who have previously been treated with anti-vegf medication as well as high risk patients with malignant neoplasms."
Are patients being actively sought for this research project?
"This study, which is currently recruiting participants, was first posted on clinicaltrials.gov on 9/23/2022 and was last edited on the same date."
How many study participants are receiving treatment?
"That is correct. The clinicaltrials.gov website has information suggesting that this study is still looking for participants. This research was originally posted on September 23rd, 2020 and the listing was edited on the same date. There are 1 locations where researchers are 6 patients total."
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