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PD-L1 Inhibitor
Atezolizumab + Cabozantinib for Glioblastoma
Phase 1 & 2
Recruiting
Led By Shiao-Pei S Weathers
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a performance status of >= 60 on the Karnofsky performance status (KPS)
Patients must be at least 12 weeks out from completion of concurrent chemoradiation
Must not have
Has received radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment
Evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
Adults (18+) with recurrent glioblastoma previously treated with radiation and temozolomide, who have a Karnofsky performance status of >=60. Must not be pregnant or breastfeeding, agree to use contraception, and have adequate organ function as indicated by specific lab values. Cannot join if they've had certain other cancer treatments, serious medical conditions that interfere with the study, or known allergies to trial medications.
What is being tested?
The safety and effectiveness of combining Atezolizumab (an immunotherapy drug) with Cabozantinib (a drug that blocks tumor growth enzymes) in shrinking tumors for patients whose glioblastoma has returned after treatment.
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs, fatigue, liver issues reflected in blood tests, high blood pressure problems from Cabozantinib; plus typical chemotherapy-related side effects like nausea and low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself but may need occasional help.
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It has been at least 12 weeks since I finished my combined chemotherapy and radiation treatment.
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I have been treated with radiation and temozolomide before.
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I am 18 years old or older.
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My kidney function is within the normal range or slightly above.
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My condition has returned for the first or second time.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had radiation for bone metastasis in 2 weeks or any radiation in 4 weeks.
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I have a tumor affecting my digestive system or a serious digestive condition.
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I have a history of HIV or active hepatitis B or C.
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I am experiencing side effects from previous radiation therapy.
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I have had cancer treatments directly in the tumor area but not Gliadel wafers or Optune device.
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I am currently being treated for an infection.
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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.
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I have a lung condition not caused by an infection.
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I have or am at risk for an autoimmune disease.
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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.
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I don't have any upcoming surgeries and have healed from past ones.
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My rash covers less than 10% of my body.
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I have not had signs of infection in the last 2 weeks.
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I have not taken any antibiotics in the last 2 weeks.
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I have not received a live flu vaccine within the last 4 weeks and won't during the study.
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I have been treated with drugs targeting PD-1 or PD-L1.
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I have previously been treated with medication targeting blood vessel growth in cancer.
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I cannot swallow pills.
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I have or had nephrotic syndrome.
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I have had a severe hypertension crisis or brain issues due to high blood pressure.
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I have heart failure that affects my daily activities.
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I have not had a stroke or TIA in the last 6 months.
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I haven't had significant bleeding, like coughing up or vomiting blood, in the last 3 months.
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I haven't taken any immune-weakening medications in the last 2 weeks.
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My heart's electrical activity (QTcF) is not over 500 ms.
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I have a history of lung scarring or inflammation.
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I have lung lesions with cavities or disease in my airways.
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I tested positive for hepatitis C but do not currently have the virus in my blood.
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I have active tuberculosis.
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I do not have a bleeding disorder or blood clotting problem that isn't treated with medication.
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I am not in any other cancer treatment trials since finishing chemoradiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Objective response rate
Progression-free survival (PFS)
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab, cabozantinib)Experimental Treatment2 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 and cabozantinib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5850
Cabozantinib
2020
Completed Phase 2
~1760
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,695 Total Patients Enrolled
43 Trials studying Glioblastoma
1,820 Patients Enrolled for Glioblastoma
Shiao-Pei S WeathersPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
160 Total Patients Enrolled
3 Trials studying Glioblastoma
110 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (atezolizumab, cabozantinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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