Actively Recruiting
A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in Recurrent Glioblastoma The MOAB Trial
Led by Duke University · Updated on 2026-04-21
80
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine if neoadjuvant atezolizumab therapy benefits patients with recurrent glioblastoma who have a low tumor mutational burden. Recurrent glioblastoma is a severe brain cancer with a poor prognosis and limited treatment options. The study investigates the complex interaction between the immune system and glioblastoma, focusing on molecular factors related to immune response and immunotherapy outcomes, especially in tumors with low mutational burden. The study involves 80 patients eligible for surgical tumor removal. Each patient receives one dose of atezolizumab before surgery, and the removed tumor tissue is analyzed to confirm recurrence and assess tumor mutational burden. Patients are then divided into two groups based on tumor mutational burden (low and high), and all receive postoperative atezolizumab until disease progression or other reasons for stopping treatment. The study compares survival after treatment between the two groups. Participants will undergo tumor surgery and receive atezolizumab at specific times during the study. Researchers will monitor survival, progression-free survival, and side effects related to atezolizumab over up to 24 months. Blood tests and other assessments will ensure organ function and safety. The study includes detailed biological analyses of tumor tissue to explore molecular markers linked to immunotherapy response. Participants will be followed closely for treatment effects and safety throughout the study.
CONDITIONS
Brief Title
A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed glioblastoma, IDH wild type
- First or second recurrence of glioblastoma after radiation and temozolomide treatment
- Tissue available from initial glioblastoma diagnosis
- Adequate organ function including hemoglobin ≥9 g/dl, platelet count ≥75,000/µl, neutrophil count ≥1000 cells/mm3, creatinine ≤1.5 times upper limit of normal, total bilirubin ≤1.5 times upper limit of normal (with exceptions), alkaline phosphatase ≤2.5 times upper limit of normal, AST and ALT ≤2.5 times upper limit of normal, serum albumin ≥25 g/L, and normal coagulation times
- Karnofsky Performance Status of 70% or higher
- Non-childbearing potential or agreement to use effective birth control methods
- Signed informed consent
- Negative HIV test or stable HIV with controlled viral load
- Negative hepatitis B and C tests or controlled infection as specified
You will not qualify if you...
- Pregnancy, breastfeeding, or intention to become pregnant during treatment or within 5 months after final dose
- Prior immunotherapy treatment
- Bevacizumab treatment within 4 weeks before biopsy (with some exceptions)
- Recent systemic immunosuppressive medication use, except for specified low-dose or inhaled steroids
- History of severe allergic reactions to antibodies or atezolizumab components
- Active autoimmune diseases or immune deficiencies with some controlled exceptions
- Less than 12 weeks from radiation therapy unless disease progression confirmed
- Contraindication to surgery
- Significant recent cardiovascular disease or unstable conditions
- Major surgery within 4 weeks prior to treatment
- Recent or active malignancies with some exceptions
- Severe infection within 4 weeks prior to treatment
- Recent live vaccine use or planned use during treatment or shortly after
- Treatment with investigational therapy within 28 days
- Prior treatment with certain immune checkpoint therapies
- Uncontrolled effusions requiring frequent drainage
- Uncontrolled or symptomatic high calcium levels
- Active tuberculosis
- History or evidence of certain lung diseases or active pneumonitis
- Recent therapeutic antibiotics use with exceptions
- Prior allogeneic stem cell or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From initial atezolizumab dose prior to surgery until progression or discontinuation
Participants receive one dose of atezolizumab before surgery followed by surgical tumor resection. After surgery, participants continue receiving atezolizumab until disease progression, unacceptable toxicity, death, or withdrawal of consent.
1 pre-surgery visit and multiple post-operative visits during atezolizumab treatment
Duration - Up to 24 months after treatment starts
Participants are monitored for survival and adverse events for up to 24 months after starting treatment.
Regular follow-up visits for assessments
Trial Site Locations
Total: 4 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Active, Not Recruiting
3
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
4
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
M
Mustafa Khasraw, MD
M
Monika Anand, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here