Actively Recruiting
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Led by Global Coalition for Adaptive Research · Updated on 2026-05-08
2250
Participants Needed
63
Research Sites
565 weeks
Total Duration
On this page
Sponsors
G
Global Coalition for Adaptive Research
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\*).
CONDITIONS
Official Title
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed Grade IV glioblastoma or gliosarcoma (IDH wild-type) by biopsy or surgery
- MRI scan within 21 days prior to randomization with required imaging sequences
- Karnofsky performance status of at least 60% (newly diagnosed) or 70% (recurrent) within 14 days prior to randomization
- Availability of tumor tissue from surgery or biopsy
- For recurrent GBM: evidence of disease progression confirmed by two scans
- For recurrent GBM: first or second recurrence after initial therapy including radiation
You will not qualify if you...
- Prior treatment for glioma including chemotherapy, radiation, immunotherapy, or intracerebral agents (newly diagnosed)
- Receiving other active therapy for GBM outside the trial
- Extensive leptomeningeal disease
- QTc interval greater than 470 milliseconds
- History of another malignancy within the past 2 years, except in situ cancer or certain skin cancers
- Early disease progression within 3 months after radiation (recurrent)
- More than 2 prior chemotherapy lines (recurrent)
- Prior treatment with lomustine, bevacizumab, or other VEGF-targeted agents (recurrent)
- Prior treatment with prolifeprospan 20 with carmustine wafer
- More than 2 prior lines of chemotherapy for recurrent GBM
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 63 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
3
Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Actively Recruiting
4
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
5
St. Joseph Hospital
Orange, California, United States, 92868
Actively Recruiting
6
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
7
Stanford Cancer Center
Stanford, California, United States, 94305
Completed
8
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Yale Cancer Center / Smilow Cancer Hospital
New Haven, Connecticut, United States, 06511
Actively Recruiting
10
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
Completed
11
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
12
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
13
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Actively Recruiting
14
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Completed
15
LSU Health Sciences Center - New Orleans
New Orleans, Louisiana, United States, 70112
Active, Not Recruiting
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
17
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
18
Henry Ford Health System
Detroit, Michigan, United States, 48202
Active, Not Recruiting
19
Allina Health Systems/Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
20
Mayo Clinic Cancer Center - Rochester
Rochester, Minnesota, United States, 55905
Completed
21
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39213
Completed
22
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Completed
23
Perlmutter Cancer Center, NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
24
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
25
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
26
Memorial Sloan Kettering Cancer Center*
New York, New York, United States, 10065
Actively Recruiting
27
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
28
Comprehensive Cancer Center of Wake Forest*
Winston-Salem, North Carolina, United States, 272157
Actively Recruiting
29
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
30
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
31
Ohio State University Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
32
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
33
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Active, Not Recruiting
34
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
35
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
36
Texas Oncology - Austin
Austin, Texas, United States, 78705
Active, Not Recruiting
37
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Active, Not Recruiting
38
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
39
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
40
University of Virginia Health
Charlottesville, Virginia, United States, 22908
Actively Recruiting
41
University of Washington Medical Center
Seattle, Washington, United States, 98101
Active, Not Recruiting
42
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Active, Not Recruiting
43
Northern Sydney Cancer Centre/Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
44
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
45
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Actively Recruiting
46
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
47
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
48
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Actively Recruiting
49
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
50
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
51
Montreal Neurological Institute and Hospital, McGill University
Montreal, Quebec, Canada, H3A 2B4
Actively Recruiting
52
Université de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5H3
Active, Not Recruiting
53
Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer
Bron, France, 69677
Actively Recruiting
54
Hopital de la Timone
Marseille, France, 13005
Actively Recruiting
55
Hopital Piti-Salpetriere
Paris, France, 75013
Actively Recruiting
56
Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie
Cologne, Germany, 50937
Active, Not Recruiting
57
Dr. Senckenbergisches Institut für Neuroonkologie
Frankfurt, Germany, 60528
Actively Recruiting
58
Universitätsklinik Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
59
Universitaetsklinikum Heidelberg - Neurologische Klinik
Mannheim, Germany, 68167
Actively Recruiting
60
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
61
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
62
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
63
University Hospital Zurich
Zurich, Switzerland
Actively Recruiting
Research Team
P
Patient Information
CONTACT
R
Rachel Rosenstein-Sisson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
17
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