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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
Must not have
Prior treatment with CD137 agonists or immune checkpoint blockade therapies
Uncontrolled tumor-related pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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 below
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I can take care of myself but might not be able to do heavy physical work.
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My tumor is 3.5 cm or smaller.
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I am eligible for surgery aimed at removing more than 80% of my cancer lesion.
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I have been diagnosed with Grade IV glioblastoma multiforme.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with CD137 agonists or immune checkpoint inhibitors.
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My cancer pain is not managed with current treatments.
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My brain cancer has spread widely or affects both sides of my brain.
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I have high calcium levels in my blood that are causing symptoms.
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I have a serious heart condition.
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I have had a stem cell or organ transplant from another person.
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I need frequent procedures to remove fluid buildup in my chest or abdomen.
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I am on a high dose of corticosteroids or more than 8 mg/day of dexamethasone.
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I have had cancer other than my current diagnosis within the last year.
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I am taking medication that weakens my immune system.
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I am currently receiving treatment that boosts my immune system.
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I have a history of specific lung conditions or currently have active lung inflammation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 • NCT02008227
36%
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%
Dysgeusia
8%
Headache
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
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

Awards & Highlights

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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
223 Previous Clinical Trials
41,540 Total Patients Enrolled
1 Trials studying Glioblastoma
13 Patients Enrolled for Glioblastoma
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,988 Total Patients Enrolled
34 Trials studying Glioblastoma
1,954 Patients Enrolled for Glioblastoma
Alexander Stessin, MDPrincipal InvestigatorStony Brook Cancer Center

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05423210 — Phase < 1
Glioblastoma Research Study Groups: Treatment
Glioblastoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05423210 — Phase < 1
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05423210 — Phase < 1
~5 spots leftby Aug 2026
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