Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT03970447

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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