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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 > 450 msec if male and QTc > 470 msec if female.
  • - 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 > 450 msec if male and QTc > 470 msec if female.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03970447
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Global Coalition for Adaptive Research
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tim Cloughesy, MD
Principal Investigator Affiliation GCAR CMO and GBM AGILE Global PI
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Australia, Canada, France, Germany, Switzerland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Study Website: View Trial Website
Additional Details

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. Its goals are to identify effective therapies for glioblastoma and match effective therapies with patient subtypes. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to Arms based on their performance. The primary endpoint is overall survival (OS). GBM AGILE is designed to efficiently evaluate therapies. The trial will be conducted under a single Master Investigational New Drug Application/Clinical Trial Application and Master Protocol, allowing multiple drugs and drug combinations from different pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental therapies as new information about promising new drugs are identified and remove therapies as they complete their evaluation.

Arms & Interventions

Arms

Active Comparator: Control Arm

Newly Diagnosed GBM: Radiation therapy (XRT) 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 2-6 weeks from the last day of radiation, and the start of the first cycle of Maintenance Therapy 2-6 weeks after the last day of radiotherapy. The start of all subsequent maintenance therapy cycles (2-12) every 4 weeks + 7 days after the first daily dose of temozolomide of the preceding cycle. Total number of cycles should comply with institutional or country standards. During maintenance therapy, the first cycle of temozolomide will be at 150 mg/m2 for Days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for Days 1-5 of a 28-day cycle. Recurrent GBM: Lomustine started at 110 mg/m2/day on Day 1 of a 42-day cycle as per local standards. Treatment will continue for up to 6 total cycles.

Experimental: Regorafenib Treatment Arm

Newly Diagnosed MGMT Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: Regorafenib (Dosage Form: Tablet for oral administration; Strength: 40 mg) 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Recurrent GBM: Regorafenib (Dosage Form: Tablet for oral administration; Strength: 40 mg) 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).

Experimental: Paxalisib Treatment Arm

Newly Diagnosed MGMT Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: Paxalisib (Dosage Form: Tablet for oral administration; Strength: 15 mg per tablet) 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. Recurrent GBM: Paxalisib (Dosage Form: Tablet for oral administration; Strength: 15 mg per tablet) 45 mg orally (PO) every day for 21 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 21 days for all subsequent cycles.

Experimental: VAL-083 Treatment Arm

Newly Diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: VAL-083 (Dosage Form: Infusion for intravenous administration; Strength: 30 mg/m2) on Day 1, 2 and 3 of 21-day cycle. Recurrent GBM: VAL-083 (Dosage Form: Infusion for intravenous administration; Strength: 30 mg/m2) on Day 1, 2 and 3 of 21-day cycle.

Experimental: VT1021 Treatment Arm - Dose Finding Phase

Newly diagnosed MGMT Methylated and Unmethylated GBM: Rolling 6 design. Treatment as outlined in section "Experimental: VT1021 Treatment Arm" with the first 6 patients receiving VT1021 at 12 mg/kg twice weekly in combination with temozolomide and radiation therapy. If there are two dose limiting toxicities reported, the dose will be de-escalated to 9 mg/kg two times a week. 6 patients will then be receiving 9 mg/kg two times a week and observed for DLTs for 4 weeks. Recurrent GBM: Dose Finding Phase is not applicable for patients with Recurrent GBM in the VT1021 treatment arm.

Experimental: VT1021 Treatment Arm - Enhanced Safety Management (ESM)

Experimental: VT1021 Treatment Arm - Enhanced Safety Management (ESM) Newly diagnosed MGMT Methylated and Unmethylated GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. PK and PD assessments are done for patients as a part of ESM. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data. Recurrent GBM: ESM is not applicable for patients with Recurrent GBM in the VT1021 treatment arm.

Experimental: VT1021 Treatment Arm

Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily and VT1021 (Dosage Form: Infusion for intravenous administration; Strength: 10 mg/mL; Dose: As confirmed through the dose finding phase) twice weekly during radiation therapy. Rest period: 2-6 weeks from last day of radiation. VT1021 dosing will continue during the rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with VT1021. After 6 cycles, VT1021 only. Recurrent GBM: VT1021 (Dosage Form: Infusion for intravenous administration; Strength: 10 mg/mL; Dose: 12mg/kg) twice weekly.

Experimental: Troriluzole Treatment Arm - Dose Finding Phase

Newly diagnosed MGMT Methylated and Unmethylated GBM: Rolling 6 design. The first 6 patients will receive troriluzole at 100 mg BID for the first two weeks followed by 200 mg BID for the next two weeks in combination with temozolomide and radiation therapy. If there are two dose limiting toxicities (DLTs) reported, the dose will be de-escalated to 100 mg in the morning and followed by 200 mg in the evening. 6 patients will receive this dose and observed for 4 weeks. If there are two DLTs reported, then this dose will be de-escalated to 100 mg BID. 6 patients will then be receiving this dose and observed for DLTs for 4 weeks. Recurrent GBM: Rolling 6 design. The first 6 patients receiving troriluzole 100 mg twice a day (BID) for the first two weeks followed by 200 mg BID for the next two weeks in combination with lomustine. The dose de-escalation is similar to that of newly diagnosed patients during the rolling 6 design.

Experimental: Troriluzole Treatment Arm - Enhanced Safety Management (ESM)

Newly diagnosed MGMT Methylated and Unmethylated GBM and Recurrent GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.

Experimental: Troriluzole Treatment Arm

Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg/m2 orally daily and troriluzole (Dosage Form: Capsule for oral administration; Strength: 100 mg; Dose: As confirmed by dose finding phase) BID. Rest period: 2-6 weeks from last day of radiation. Troriluzole dosing will continue during the rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with troriluzole. After 6 cycles, troriluzole only. Recurrent GBM: Lomustine 100 mg/m2 orally on day 1 of a 42-day cycle in combination with troriluzole (Dosage Form: Capsule for oral administration; Strength: 100 mg; Dose: As confirmed by dose finding phase) BID. After 6 cycles, troriluzole only.

Experimental: ADI-PEG 20 Treatment Arm - Dose Finding Phase

Newly diagnosed MGMT Methylated and Unmethylated GBM: Dose Finding Phase is not applicable for newly diagnosed patients on the ADI-PEG 20 treatment arm. Recurrent GBM: Rolling 6 design. The first 6 patients will receive ADI-PEG 20 at 36 mg/m2 once a week in combination with lomustine 100 mg/m2 orally on day 1 of a 42-day cycle. 6 patients will receive this dose and be observed for 4 weeks. If there are two dose limiting toxicities (DLTs) reported, the dose will be de-escalated to 18 mg/m2 once a week. 6 patients will receive this dose and be observed for 4 weeks.

Experimental: ADI-PEG 20 Treatment Arm - Enhanced Safety Management (ESM)

Newly diagnosed MGMT Methylated and Unmethylated GBM: ESM is not applicable for newly diagnosed patients on the ADI-PEG 20 treatment arm. Recurrent GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.

Experimental: ADI-PEG 20 Treatment Arm

Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy over 6 weeks. Temozolomide (75 mg/m2 orally daily and ADI-PEG 20 (Dosage Form: Solution for intramuscular injection; Strength: 11.5 ± 1.0 mg/ml; Dose: 36 mg/m2) once a week. Rest period: 2-6 weeks from last day of radiation. ADI-PEG 20 dosing will continue during rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Subsequent cycles will be at 200 mg/m2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with ADI-PEG 20. After 6 cycles, ADI-PEG 20 only for up to 104 weeks of total treatment. Recurrent GBM: Lomustine 100 mg/m2 orally on day 1 of a 42-day cycle in combination with ADI-PEG 20 (Dosage Form: Solution for IM injection; Strength: 11.5 ± 1.0 mg/ml; Dose: As confirmed by dose finding phase, once a week. After 6 cycles, ADI-PEG 20 only for up to 104 weeks of total treatment.

Experimental: AZD1390 Treatment Arm

Newly Diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks in combination with AZD1390 given on days of radiation followed by 14 days with daily AZD1390. Rest Period 2-4 weeks from the last day of AZD1390. The first cycle of temozolomide will be at 150 mg/m2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg/m2 for days 1-5 of a 28-day cycle, if there is no toxicity. Temozolomide will be administered for up to 6 cycles in the maintenance phase.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham 4049979, Alabama 4829764, 35249

Site Contact

Shirley Gibbs

[email protected]

(205) 975-0447

University of California, San Diego, La Jolla 5363943, California 5332921

Status

Recruiting

Address

University of California, San Diego

La Jolla 5363943, California 5332921, 92093

Site Contact

Sheila Medina-Torne

[email protected]

858-822-1847

Los Angeles 5368361, California 5332921

Status

Recruiting

Address

Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute

Los Angeles 5368361, California 5332921, 90048

Site Contact

Anna Rosen

[email protected]

310-248-7640

University of California, Los Angeles, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

University of California, Los Angeles

Los Angeles 5368361, California 5332921, 90095

Site Contact

Emy Filka

[email protected]

310-794-3521

St. Joseph Hospital, Orange 5379513, California 5332921

Status

Recruiting

Address

St. Joseph Hospital

Orange 5379513, California 5332921, 92868

Site Contact

Christine Lichti

[email protected]

714-714-6220

University of California, San Francisco, San Francisco 5391959, California 5332921

Status

Recruiting

Address

University of California, San Francisco

San Francisco 5391959, California 5332921, 94143

Site Contact

UCSF Neuro Onc New Patient Coordinator

[email protected]

(415) 353-2193

Stanford Cancer Center, Stanford 5398563, California 5332921

Status

Completed

Address

Stanford Cancer Center

Stanford 5398563, California 5332921, 94305

University of Colorado Denver, Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

University of Colorado Denver

Aurora 5412347, Colorado 5417618, 80045

Site Contact

Meaghan Greb, MPH

[email protected]

303-724-9690

New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale Cancer Center / Smilow Cancer Hospital

New Haven 4839366, Connecticut 4831725, 06511

Site Contact

Phyllis Nortey

[email protected]

203-737-1881

Mayo Clinic Cancer Center, Jacksonville 4160021, Florida 4155751

Status

Completed

Address

Mayo Clinic Cancer Center

Jacksonville 4160021, Florida 4155751, 32224

Sylvester Comprehensive Cancer Center, Miami 4164138, Florida 4155751

Status

Recruiting

Address

Sylvester Comprehensive Cancer Center

Miami 4164138, Florida 4155751, 33136

Site Contact

Yaima de la Fuente

[email protected]

305-243-5189

Moffitt Cancer Center, Tampa 4174757, Florida 4155751

Status

Recruiting

Address

Moffitt Cancer Center

Tampa 4174757, Florida 4155751, 33612

Site Contact

Sebastian Matzza

[email protected]

813-745-1158

Piedmont Atlanta Hospital, Atlanta 4180439, Georgia 4197000

Status

Recruiting

Address

Piedmont Atlanta Hospital

Atlanta 4180439, Georgia 4197000, 30309

Site Contact

Ali Arabnia

[email protected]

404-425-7943

Atlanta 4180439, Georgia 4197000

Status

Completed

Address

Winship Cancer Institute of Emory University

Atlanta 4180439, Georgia 4197000, 30322

LSU Health Sciences Center - New Orleans, New Orleans 4335045, Louisiana 4331987

Status

Active, not recruiting

Address

LSU Health Sciences Center - New Orleans

New Orleans 4335045, Louisiana 4331987, 70112

Massachusetts General Hospital, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Massachusetts General Hospital

Boston 4930956, Massachusetts 6254926, 02114

Site Contact

Lauren Hibyan

[email protected]

617-643-8992

Dana Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02115

Site Contact

Jennifer Borowka

[email protected]

617-632-2166

Henry Ford Health System, Detroit 4990729, Michigan 5001836

Status

Active, not recruiting

Address

Henry Ford Health System

Detroit 4990729, Michigan 5001836, 48202

Abbott Northwestern Hospital, Minneapolis 5037649, Minnesota 5037779

Status

Recruiting

Address

Abbott Northwestern Hospital

Minneapolis 5037649, Minnesota 5037779, 55407

Mayo Clinic Cancer Center - Rochester, Rochester 5043473, Minnesota 5037779

Status

Completed

Address

Mayo Clinic Cancer Center - Rochester

Rochester 5043473, Minnesota 5037779, 55905

University of Mississippi Medical Center, Jackson 4431410, Mississippi 4436296

Status

Completed

Address

University of Mississippi Medical Center

Jackson 4431410, Mississippi 4436296, 39213

St Louis 4407066, Missouri 4398678

Status

Completed

Address

Washington University School of Medicine - Siteman Cancer Center

St Louis 4407066, Missouri 4398678, 63110

New York 5128581, New York 5128638

Status

Recruiting

Address

Perlmutter Cancer Center, NYU Langone Health

New York 5128581, New York 5128638, 10016

Site Contact

Bronson/Rachel Krull/Kim

#[email protected]

212-731-6267

Icahn School of Medicine at Mount Sinai, New York 5128581, New York 5128638

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York 5128581, New York 5128638, 10029

Site Contact

Suzette Days-Mays

[email protected]

646-531-4350

Columbia University Medical Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Columbia University Medical Center

New York 5128581, New York 5128638, 10032

Site Contact

Denisse Torres

[email protected]

212-304-6329

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Site Contact

Lindsey Myers

[email protected]

917-453-2968

Duke University Medical Center, Durham 4464368, North Carolina 4482348

Status

Recruiting

Address

Duke University Medical Center

Durham 4464368, North Carolina 4482348, 27710

Site Contact

Erin K Bell

[email protected]

919-668-6230

Winston-Salem 4499612, North Carolina 4482348

Status

Recruiting

Address

Comprehensive Cancer Center of Wake Forest

Winston-Salem 4499612, North Carolina 4482348, 272157

Site Contact

Ashley Fansler

[email protected]

336-713-3551

Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland 5150529, Ohio 5165418, 44106

Site Contact

Melissa Brately

[email protected]

310-598-3199

Cleveland Clinic, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

Cleveland Clinic

Cleveland 5150529, Ohio 5165418, 44195

Site Contact

Herbert Newton, MD

[email protected]

216-444-8923

Ohio State University Cancer Center, Columbus 4509177, Ohio 5165418

Status

Recruiting

Address

Ohio State University Cancer Center

Columbus 4509177, Ohio 5165418, 43210

Site Contact

Nasir Muhammad

[email protected]

614-293-4448

Philadelphia 4560349, Pennsylvania 6254927

Status

Recruiting

Address

University of Pennsylvania - Perelman Center for Advanced Medicine

Philadelphia 4560349, Pennsylvania 6254927, 19104

Site Contact

Emily McCoy

[email protected]

609-741-0009

Allegheny General Hospital, Pittsburgh 5206379, Pennsylvania 6254927

Status

Active, not recruiting

Address

Allegheny General Hospital

Pittsburgh 5206379, Pennsylvania 6254927, 15212

Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh 5206379, Pennsylvania 6254927, 15232

Site Contact

Tyler Boyce

[email protected]

(412) 623-3962

Charleston 4574324, South Carolina 4597040

Status

Recruiting

Address

Medical University of South Carolina - Hollings Cancer Center

Charleston 4574324, South Carolina 4597040, 29425

Site Contact

Jennifer Kinsey

[email protected]

843-792-1484

Texas Oncology - Austin, Austin 4671654, Texas 4736286

Status

Active, not recruiting

Address

Texas Oncology - Austin

Austin 4671654, Texas 4736286, 78705

Dallas 4684888, Texas 4736286

Status

Recruiting

Address

University of Texas Southwestern Medical Center

Dallas 4684888, Texas 4736286, 75390

Site Contact

Tammy Ricklefs

[email protected]

(214) 645-1853

Houston 4699066, Texas 4736286

Status

Recruiting

Address

University of Texas - MD Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

Evguenia Gachimova, RN

[email protected]

(832)266-3519

Salt Lake City 5780993, Utah 5549030

Status

Recruiting

Address

University of Utah - Huntsman Cancer Institute

Salt Lake City 5780993, Utah 5549030, 84112

Site Contact

Rachel Kingsford

[email protected]

801-585-0550

University of Virginia Health, Charlottesville 4752031, Virginia 6254928

Status

Recruiting

Address

University of Virginia Health

Charlottesville 4752031, Virginia 6254928, 22908

Site Contact

CJ Woodburn

[email protected]

434-243-9900

University of Washington Medical Center, Seattle 5809844, Washington 5815135

Status

Active, not recruiting

Address

University of Washington Medical Center

Seattle 5809844, Washington 5815135, 98101

Milwaukee 5263045, Wisconsin 5279468

Status

Active, not recruiting

Address

Froedtert Hospital/Medical College of Wisconsin

Milwaukee 5263045, Wisconsin 5279468, 53226

International Sites

St Leonards 8029783, New South Wales 2155400, Australia

Status

Recruiting

Address

Northern Sydney Cancer Centre/Royal North Shore Hospital

St Leonards 8029783, New South Wales 2155400, 2065

Site Contact

Daisy Yu

[email protected]

(02) 9463 1217

Calvary Mater Newcastle, Waratah 10103871, New South Wales 2155400, Australia

Status

Recruiting

Address

Calvary Mater Newcastle

Waratah 10103871, New South Wales 2155400, 2298

Site Contact

Kim Adler

[email protected]

+61 (0)2 40143282

Royal Brisbane and Women's Hospital, Herston 6931014, Queensland 2152274, Australia

Status

Recruiting

Address

Royal Brisbane and Women's Hospital

Herston 6931014, Queensland 2152274, 4029

Site Contact

Jade Allan

[email protected]

+61 7 3647 0782

Flinders Medical Centre, Bedford Park 2076918, South Australia 2061327, Australia

Status

Recruiting

Address

Flinders Medical Centre

Bedford Park 2076918, South Australia 2061327, 5042

Site Contact

Monique Swan

[email protected]

(08) 8404 2702

Austin Health, Heidelberg 2163654, Victoria 2145234, Australia

Status

Recruiting

Address

Austin Health

Heidelberg 2163654, Victoria 2145234, 3084

Site Contact

Samantha Chakar

[email protected]

(03) 9496 3088

Peter MacCallum Cancer Centre, Melbourne 2158177, Victoria 2145234, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Centre

Melbourne 2158177, Victoria 2145234,

Site Contact

Richelle Linklater

[email protected]

310-598-3199

Sunnybrook Health Sciences Centre, Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

Sunnybrook Health Sciences Centre

Toronto 6167865, Ontario 6093943, M4N 3M5

Site Contact

Delareese Mackenzie

[email protected]

416-480-5000 #7362

Princess Margaret Cancer Centre, Toronto 6167865, Ontario 6093943, Canada

Status

Active, not recruiting

Address

Princess Margaret Cancer Centre

Toronto 6167865, Ontario 6093943, M5G 2C1

Montreal 6077243, Quebec 6115047, Canada

Status

Recruiting

Address

Montreal Neurological Institute and Hospital, McGill University

Montreal 6077243, Quebec 6115047, H3A 2B4

Site Contact

Gabriele Riva

[email protected]

514-398-6907

Université de Sherbrooke, Sherbrooke 6146143, Quebec 6115047, Canada

Status

Active, not recruiting

Address

Université de Sherbrooke

Sherbrooke 6146143, Quebec 6115047, J1H 5H3

Bron 3029931, France

Status

Active, not recruiting

Address

Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer

Bron 3029931, , 69677

Hopital de la Timone, Marseille 2995469, France

Status

Active, not recruiting

Address

Hopital de la Timone

Marseille 2995469, , 13005

Hopital Piti-Salpetriere, Paris 2988507, France

Status

Active, not recruiting

Address

Hopital Piti-Salpetriere

Paris 2988507, , 75013

Cologne 2886242, Germany

Status

Active, not recruiting

Address

Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie

Cologne 2886242, , 50937

Frankfurt 2925536, Germany

Status

Active, not recruiting

Address

Dr. Senckenbergisches Institut für Neuroonkologie

Frankfurt 2925536, , 60528

Universitätsklinik Heidelberg, Heidelberg 2907911, Germany

Status

Active, not recruiting

Address

Universitätsklinik Heidelberg

Heidelberg 2907911, , 69120

Universitätsklinikum Regensburg, Regensburg 2849483, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Regensburg

Regensburg 2849483, , 93053

Universitätsklinikum Tübingen, Tübingen 2820860, Germany

Status

Active, not recruiting

Address

Universitätsklinikum Tübingen

Tübingen 2820860, , 72076

Lausanne 2659994, Canton of Vaud 2658182, Switzerland

Status

Active, not recruiting

Address

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne 2659994, Canton of Vaud 2658182, 1011

University Hospital Zurich, Zurich 2657896, Switzerland

Status

Active, not recruiting

Address

University Hospital Zurich

Zurich 2657896, ,