Your session is about to expire
← Back to Search
PD-L1 Inhibitor
Atezolizumab + Radiation for Glioblastoma
Phase < 1
Recruiting
Led By Alexander Stessin, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG status <= 2
Tumor volume <= 3.5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trialstudies a new combo treatment for Glioblastoma, a malignant brain tumor. Patients will receive a 2 week combination of radiotherapy and a drug, then have surgery and continue with the drug.
Who is the study for?
This trial is for patients with a new diagnosis of Glioblastoma Multiforme, a serious brain tumor. They must be candidates for surgery aiming to remove over 80% of the tumor, have good organ function and performance status (ECOG <=2), and not be pregnant. Exclusions include recent other cancers, severe infections or diseases, high steroid use, certain heart conditions, immune system issues like autoimmune disease or prior immunotherapy.Check my eligibility
What is being tested?
The study tests Atezolizumab combined with FSRT radiation in treating Glioblastoma before and after surgical removal of the tumor. Patients will receive two doses of Atezolizumab along with two weeks of radiotherapy followed by surgery and then continue Atezolizumab every two weeks during adjuvant treatment.See study design
What are the potential side effects?
Atezolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), infusion reactions; fatigue; possible increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My tumor is 3.5 cm or smaller.
Select...
I am eligible for surgery aimed at removing more than 80% of my cancer lesion.
Select...
I have been diagnosed with Grade IV glioblastoma multiforme.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who progress/relapse after surgical resection
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
215 Previous Clinical Trials
39,915 Total Patients Enrolled
1 Trials studying Glioblastoma
13 Patients Enrolled for Glioblastoma
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,887 Total Patients Enrolled
34 Trials studying Glioblastoma
1,954 Patients Enrolled for Glioblastoma
Alexander Stessin, MDPrincipal InvestigatorStony Brook Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with CD137 agonists or immune checkpoint inhibitors.My organs are working well.My cancer pain is not managed with current treatments.My brain cancer has spread widely or affects both sides of my brain.I can take care of myself but might not be able to do heavy physical work.I have high calcium levels in my blood that are causing symptoms.I have a serious heart condition.My tumor is 3.5 cm or smaller.I have had a stem cell or organ transplant from another person.I need frequent procedures to remove fluid buildup in my chest or abdomen.I am eligible for surgery aimed at removing more than 80% of my cancer lesion.I have not had a severe infection in the last 4 weeks.I am on a high dose of corticosteroids or more than 8 mg/day of dexamethasone.I have had cancer other than my current diagnosis within the last year.I am taking medication that weakens my immune system.I am currently receiving treatment that boosts my immune system.I have a history of specific lung conditions or currently have active lung inflammation.I have been diagnosed with Grade IV glioblastoma multiforme.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolment for this experiment still accessible?
"Clinicaltrials.gov indicates that this research study is presently searching for participants, with initial posting on September 21st 2022 and the most recent edit occurring November 2nd 2022."
Answered by AI
How extensive is the current participation in this clinical experiment?
"Affirmative. Clinicaltrials.gov corroborates that this trial is actively seeking participants, having been first listed on September 21st 2022 and modified most recently on November 2nd 2022. This study requires a total of 12 patients from 1 medical centre."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger