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Checkpoint Inhibitor

Pre-Surgery Atezolizumab for 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

MOAB Trial 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.Check my eligibility

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.See study design

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.

MOAB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of treatment until 30 days post last dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Peripheral sensory neuropathy

Pain in extremity

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

MOAB 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

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,367 Previous Clinical Trials

3,425,160 Total Patients Enrolled

39 Trials studying Glioblastoma

1,581 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the use of atezolizumab before surgery received approval from the FDA?

"In this Phase 2 trial evaluating Pre-Surgery Atezolizumab, our team at Power rates its safety as a 2 on the scale of 1 to 3. This indicates that while some data supports its safety profile, there is no existing evidence supporting its efficacy in this context."

Answered by AI

Are there any ongoing efforts to enroll participants in this clinical trial at the moment?

"Indeed, the details on clinicaltrials.gov indicate that this research endeavor is currently seeking participants. This trial was initially listed on March 21st, 2024 and underwent its most recent update on April 16th, 2024. The study aims to enroll a total of 80 patients at one designated site."

Answered by AI

What is the current number of individuals undergoing treatment within this clinical trial?

"Indeed, information provided on clinicaltrials.gov indicates that this research project is actively seeking participants. The trial was initially uploaded on 3/21/2024 and last revised on 4/16/2024. It aims to enroll 80 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial

Mustafa Khasraw, MBChB, MD, FRCP, FRACP 2024. "A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06069726.

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