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

Part of paid clinical trials in San Francisco, California.

Sponsor
Duke University
Study ID
NCT06069726
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    One dose of atezolizumab will be given prior to resection.

Study Details

This is to study if neoadjuvant atezolizumab therapy is beneficial for patients with recurrent glioblastoma and a low mutational burden.

Key Dates

Start date
Mar 21, 2024
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-Surgery Atezolizumab
    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

Primary Outcome Measure

Median survival within the low and high TMB groups [ Time Frame: Day 1 of atezolizumab treatment until death or off study due to any other reason whichever comes first, assessed for up to 24 months. If the patient is alive at the time of analysis, survival will be censored at the time of last follow-up. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
John de Groot, MD
[email protected]
415-353-2193
Saint Luke's Cancer InstituteKansas CityMissouri64111-
Duke UniversityDurhamNorth Carolina27705
Mustafa Khasraw, MD
[email protected]
919-684-5301
Monika Anand, PhD
[email protected]
9196818838
Mustafa Khasraw, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer InstituteSalt Lake CityUtah84112
Howard Colman, MD
[email protected]
801-646-4090
Yuri Kida, MSW
[email protected]
801-646-4397

Find similar trials in San Francisco, CA

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By specialty
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By research site
University of California, San Francisco· San Francisco, CASaint Luke's Cancer Institute· Kansas City, MODuke University· Durham, NCHuntsman Cancer Institute· Salt Lake City, UT

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