Clinical trial · no report yet · Phase 2/Phase 3
GBM AGILE
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
- NCT03970447 ↗
- Recruiting
- Global Coalition for Adaptive Research
- 20 commentary sources found
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| YouTube | 14 | |
| Podcasts | 3 | |
| X threads | 3 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 2/Phase 3
- Status
- Recruiting
- Conditions
- Glioblastoma
- Interventions
- Temozolomide; Lomustine; Regorafenib; Radiation; Paxalisib; VAL-083; VT1021; Troriluzole; ADI-PEG 20; AZD1390; Tinostamustine
- Arms
- Control Arm · Active comparator
- Regorafenib Treatment Arm- Enrollment concluded · Experimental
- Paxalisib Treatment Arm- Enrollment concluded · Experimental
- VAL-083 Treatment Arm- Enrollment concluded · Experimental
- VT1021 Treatment Arm - Dose Finding Phase · Experimental
- VT1021 Treatment Arm - Enhanced Safety Management (ESM) · Experimental
- VT1021 Treatment Arm · Experimental
- Troriluzole Treatment Arm - Dose Finding Phase · Experimental
- Troriluzole Treatment Arm - Enhanced Safety Management (ESM) · Experimental
- Troriluzole Treatment Arm · Experimental
- ADI-PEG 20 Treatment Arm - Dose Finding Phase · Experimental
- ADI-PEG 20 Treatment Arm - Enhanced Safety Management (ESM) · Experimental
- ADI-PEG 20 Treatment Arm · Experimental
- AZD1390 Treatment Arm · Experimental
- Tinostamustine - Dose finding phase · Experimental
- Tinostamustine - Enhanced Safety Management · Experimental
- Investigation arm: Tinostamustine · Experimental
- Enrollment
- 2,250 (estimated)
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Global Coalition for Adaptive Research with Bayer, Kazia Therapeutics Limited, Kintara Therapeutics, Inc., Biohaven Pharmaceuticals, Inc., Vigeo Therapeutics, Inc., Polaris Group, AstraZeneca, Knoa Pharma
- Start
- Jul 30, 2019
- Primary completion
- Jun 2028 (estimated)
- Results posted
- No
- Registry record
- NCT03970447 · updated Oct 1, 2026
Publications
linked from the registry- Wen PY, Berry DA, Buxton MB, Colman H, de Groot J, Lim M, Mellinghoff I, Perry JR, Weller M, Blondin NA, Butt OH, Damek DM, de la Fuente MI, Drappatz J, Dunbar E, Giglio P, Hyddmark EV, Iwamoto F, Jaeckle KA, Kim L, Kling HM, Lee EQ, Mantica M, Mikkelsen T, Nabors B, Newton HB, Olson JJ, Schiff D, Walbert T, Weathers SP, Cloughesy T, Lassman AB; GBM AGILE Regorafenib Study Group. Evaluation of Regorafenib in Newly Diagnosed and Recurrent Glioblastoma: GBM AGILE Phase II/III Bayesian Randomized Platform Trial. J Clin Oncol. 2026 Jun 20;44(18):1676-1686. doi: 10.1200/JCO-25-01137. Epub 2026 Apr 14. PubMed 41980234
- Chen JJ, Vincent MY, Shepard D, Peereboom D, Mahalingam D, Battiste J, Patel MR, Juric D, Wen PY, Bullock A, Selfridge JE, Pant S, Liu J, Li W, Fyfe S, Wang S, Zota V, Mahoney J, Watnick RS, Cieslewicz M, Watnick J. Phase 1 dose expansion and biomarker study assessing first-in-class tumor microenvironment modulator VT1021 in patients with advanced solid tumors. Commun Med (Lond). 2024 May 21;4(1):95. doi: 10.1038/s43856-024-00520-z. PubMed 38773224