Study to Evaluate Different Treatments for Brain Tumors
Zusammenfassung der Studie
The purpose of this study is to evaluate several investigational treatments for newly diagnosed or recurrent brain tumor to determine whether any of these investigational treatments improve overall survival compared to standard of care treatments.
(BASEC)
Untersuchte Intervention
As part of a screening process, it will be determined whether the patient is eligible to participate in the study. Assignment to the study treatment will depend on factors such as newly diagnosed brain tumor or recurrent brain tumor, prior cancer treatments, number of treatments received, and number of available study treatments at the time of enrollment in the study. Currently, these are a standard treatment of chemotherapy and radiation therapy and treatment with one of the new investigational drugs, either Troriluzole or ADI-PEG 20.
Treatment in the control group:
During chemotherapy and radiation therapy, patients with newly diagnosed glioblastoma receive treatment with Temozolomide during their radiation therapy, followed by a rest period. After the rest period, patients begin their maintenance phase and receive treatment with Temozolomide alone (no radiation therapy).
Patients with recurrent glioblastoma receive Lomustine during the chemotherapy treatment phase.
Treatment with the investigational medication:
Patients are assigned to one of the study arms: 1) Troriluzole arm or 2) ADI-PEG 20.
1) Troriluzole arm
For patients with newly diagnosed glioblastoma, the study begins with a chemoradiotherapy treatment period. Patients are treated with Temozolomide during radiation therapy, followed by a rest period. After the rest period, patients receive the assigned investigational medication during the maintenance phase.
Patients with recurrent glioblastoma receive Troriluzole twice daily, continuously.
2) ADI-PEG 20
For patients with newly diagnosed glioblastoma, the study begins with a chemoradiotherapy treatment period. Patients are treated with Temozolomide, radiation therapy, and the investigational substance ADI-PEG 20, followed by a rest period. During the rest period, treatment with ADI-PEG 20 continues. During the maintenance treatment period, patients receive ADI-PEG 20 in the first cycles in combination with Temozolomide. After the first 6 cycles, patients continue to receive ADI-PEG 20.
The number of treatment cycles that patients receive depends on the response to the assigned treatment. During the chemotherapy and radiation therapy treatment phase, patients receive radiation 5 times a week for 6 weeks and daily Temozolomide for 6 weeks. During the maintenance phase, patients receive either ADI-PEG 20 once a week or Troriluzole twice daily, continuously.
(BASEC)
Untersuchte Krankheit(en)
Oncology - Glioblastoma (GBM)
(BASEC)
Main inclusion criteria - Newly diagnosed: 1. Age ≥ 18 years. 2. Histologically confirmed GBM/Gliosarcoma Grade IV 3. An MRI performed preferably within 21 days prior to randomization with the required imaging sequences. (BASEC)
Ausschlusskriterien
1. Receipt of prior glioma treatment, 2. Receipt of additional active GBM therapy outside of the study. 3. Presence of extensive leptomeningeal disease. (BASEC)
Studienstandort
Lausanne, Zürich
(BASEC)
Sponsor
IQVIA AG Hochstrasse 50 CH-4053 Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
GCAR CMO and GBM AGILE Global PI,
310-598-3199
margaret.wolinska@clutteriqvia.com(ICTRP)
Allgemeine Auskünfte
GCAR CMO and GBM AGILE Global PI
310-598-3199
margaret.wolinska@clutteriqvia.com(ICTRP)
Wissenschaftliche Auskünfte
GCAR CMO and GBM AGILE Global PI,
310-598-3199
margaret.wolinska@clutteriqvia.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
07.12.2021
(BASEC)
ICTRP Studien-ID
NCT03970447 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Eine internationale, nahtlose Phase II/III-Studie mit Adaptiver Randomisierungsplattform für das Ansprechen zur Bewertung mehrerer Therapien bei neu diagnostiziertem und wiederauftretendem Glioblastom (GBM) (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (ICTRP)
Untersuchte Krankheit(en)
Glioblastoma (ICTRP)
Untersuchte Intervention
Drug: TemozolomideDrug: LomustineDrug: RegorafenibRadiation: RadiationDrug: PaxalisibDrug: VAL-083Drug: VT1021Drug: TroriluzoleBiological: ADI-PEG 20 (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Overall Survival (OS) (ICTRP)
Progression-free survival (PFS);Tumor Response;Duration of Response (CR + PR) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Bayer;Kazia Therapeutics Limited;Kintara Therapeutics, Inc.;Biohaven Pharmaceuticals, Inc.;Vigeo Therapeutics, Inc.;Polaris Group (ICTRP)
Weitere Kontakte
Tim Cloughesy, MD;Patient Information, patientinfo@gcaresearch.org, 310-598-3199, GCAR CMO and GBM AGILE Global PI, (ICTRP)
Sekundäre IDs
GCAR-7213 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03970447 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar