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RECRUITING

NCT03970447

PHASE2/PHASE3

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

Sponsor: Global Coalition for Adaptive Research

View on ClinicalTrials.gov

Summary

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.

Official title: GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2250

Start Date

2019-07-30

Completion Date

2030-06

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Glioblastoma

Interventions

DRUG

Temozolomide

Dosage Form: Capsule for oral administration Strengths: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg

DRUG

Lomustine

Dosage Form: Capsule for oral administration Strength: 5 mg, 10 mg, 40 mg, and 100 mg

DRUG

Regorafenib

Dosage Form: Tablet for oral administration Strength: 40 mg Standard Regimen: 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)

RADIATION

Radiation

60 Gy

DRUG

Paxalisib

Dosage Form: Tablet for oral administration Strength: 15 mg Standard Regimen: 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles

DRUG

VAL-083

Dosage Form: Infusion for intravenous administration Strength: 40 mg per vial Standard Regimen: 30 mg/m2 on Day 1, 2 and 3 of 21-day cycle. The drug is available in powder form. It is reconstituted with 5 mL of 0.9% Sodium Chloride for Injection, USP. This will produce a solution of 40 mg VAL-083 in 5 mL. The required volume of reconstituted VAL-083 for the patient is then calculated at the rate of 30 mg/m2. The corresponding volume is further diluted into 250 mL of 0.9% Sodium Chloride for Injection, USP, prior to intravenous administration.

DRUG

VT1021

Dosage Form: Infusion for intravenous administration Strength: 10 mg/mL Standard Regimen Newly Diagnosed: Dose as confirmed through the dose finding phase, administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). Standard Regimen Recurrent: 12 mg/kg administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). The drug is available as a sterile solution of the acetate salt formulated with phosphate-buffered saline, mannitol, and 2.5% polysorbate 80. The required volume stock solution for the patient is calculated. The corresponding volume is diluted in 500 mL of either 0.9% saline or D5W, prior to intravenous administration.

DRUG

Troriluzole

Dosage Form: Capsule for oral administration Strength: 100 mg Standard Regimen: Dose as confirmed through the dose finding phase orally BID.

BIOLOGICAL

ADI-PEG 20

Dosage Form: Solution for intramuscular injection Strength: 11.5 ± 1.0 mg/ml Standard Regimen: For newly diagnosed patients, 36mg/m2. For recurrent disease patients, dose as confirmed through the dose finding phase intramuscularly once a week

DRUG

AZD1390

Standard Regimen Newly Diagnosed: Given once daily on days of radiation and once daily for 14 consecutive days after completion of radiation.

DRUG

Tinostamustine

Dosage form: Reconstituted powder for intravenous administration Strength: 2mg/mL Standard Regimen: Dose as confirmed through the dose finding phase, on Day 1 of 21-day cycle for up to 12 cycles in the maintenance phase.

Newly Diagnosed Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \[IHC\] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained. * Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization. * Availability of tumor tissue representative of GBM from definitive surgery or biopsy. Recurrent Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \[IHC\] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT). * Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria. * Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression. * Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization. * Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed. Newly Diagnosed Exclusion Criteria: * Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial. * Extensive leptomeningeal disease. * QTc \> 470 msec * History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Recurrent Exclusion Criteria: * Early disease progression prior to 3 months (12 weeks) from the completion of RT. * More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.) * Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent. * Any prior treatment with prolifeprospan 20 with carmustine wafer. * Any prior treatment with an intracerebral agent. * Receiving additional, concurrent, active therapy for GBM outside of the trial * Extensive leptomeningeal disease. * QTc \> 470 msec * History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

Locations (63)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California, San Diego

La Jolla, California, United States

Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

St. Joseph Hospital

Orange, California, United States

University of California, San Francisco

San Francisco, California, United States

Stanford Cancer Center

Stanford, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Yale Cancer Center / Smilow Cancer Hospital

New Haven, Connecticut, United States

Mayo Clinic Cancer Center

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

LSU Health Sciences Center - New Orleans

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center - Rochester

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Perlmutter Cancer Center, NYU Langone Health

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Comprehensive Cancer Center of Wake Forest

Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Cancer Center

Columbus, Ohio, United States

University of Pennsylvania - Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina - Hollings Cancer Center

Charleston, South Carolina, United States

Texas Oncology - Austin

Austin, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia Health

Charlottesville, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Northern Sydney Cancer Centre/Royal North Shore Hospital

St Leonards, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Montreal Neurological Institute and Hospital, McGill University

Montreal, Quebec, Canada

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer

Bron, France

Hopital de la Timone

Marseille, France

Hopital Piti-Salpetriere

Paris, France

Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie

Cologne, Germany

Dr. Senckenbergisches Institut für Neuroonkologie

Frankfurt, Germany

Universitätsklinik Heidelberg

Heidelberg, Germany

Universitaetsklinikum Heidelberg - Neurologische Klinik

Mannheim, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, Canton of Vaud, Switzerland

University Hospital Zurich

Zurich, Switzerland

Clinical Research Directory

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)