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Checkpoint Inhibitor

Atezolizumab for Recurrent Glioblastoma (MOAB Trial)

Phase 2
Recruiting
Led By Mustafa Khasraw, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of treatment until 30 days post last dose
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if giving atezolizumab before surgery can help patients with recurrent glioblastoma and low mutational burden."

Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma, who've had prior radiation and TMZ treatment. They must have evidence of recurrence, tissue from their initial diagnosis, and normal levels of certain blood components like bilirubin (with exceptions for Gilbert's Syndrome), alkaline phosphatase, hemoglobin, platelets, neutrophils, and creatinine.
What is being tested?
The MOAB Trial is testing whether Atezolizumab given before surgery can help patients with recurrent glioblastoma that has a low number of genetic mutations. The study aims to find the best biomarkers to predict the effectiveness of this therapy.
What are the potential side effects?
Atezolizumab may cause side effects such as immune-related reactions affecting organs like lungs or intestines; skin issues; hormone gland problems; fatigue; liver enzymes changes; decreased appetite; nausea; infections due to weakened immune response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of treatment until 30 days post last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of treatment until 30 days post last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median survival within the low and high TMB groups
Median survival within the low and high TMB groups and their respective matched historical control group
Secondary study objectives
Compare Progression Free Survival (PFS) using mRANO criteria between low vs high TMB arms and between TMB-matched historical control arms (low and high TMB)
Proportion of patients that experience grade 3, 4, or 5 adverse events that are possibly, probably, or definitely related to atezolizumab.

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%
Headache
8%
Dysgeusia
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

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: Pre-Surgery AtezolizumabExperimental Treatment1 Intervention
80 patients with rGBM who are eligible for surgical debulking will be treated with one dose of atezolizumab prior to resection. Resected tissue will be used to pathologically confirm recurrence, and tumor tissue will be analyzed by whole exome sequencing (WES). Anticipating that40 patients with low TMB and 40 with high TMB will be treated. All treated subjects will receive post-operative atezolizumab until progression, unacceptable toxicity, death or withdrawal of consent. Post-atezolizumab survival will be compared between low vs high TMB arms to determine if low TMB associates with longer survival after atezolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,452 Previous Clinical Trials
2,971,711 Total Patients Enrolled
40 Trials studying Glioblastoma
1,774 Patients Enrolled for Glioblastoma
Mustafa Khasraw, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
105 Total Patients Enrolled
1 Trials studying Glioblastoma
34 Patients Enrolled for Glioblastoma
~50 spots leftby Jan 2026
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