OncoMatch

OncoMatch/Clinical Trials/NCT03970447

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

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

Is NCT03970447 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2/3 trial studies multiple treatments for glioblastoma.

Phase 2/3RecruitingGlobal Coalition for Adaptive ResearchNCT03970447Data as of Oct 2026Location: International · 6 countries

Treatment: Temozolomide · Lomustine · Regorafenib · Paxalisib · VAL-083 · VT1021 · Troriluzole · ADI-PEG 20 · AZD1390 · Tinostamustine — 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 (\*).

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Regorafenib

Chemotherapy

TemozolomideLomustine

Other

PaxalisibVAL-083VT1021TroriluzoleADI-PEG 20AZD1390Tinostamustine

Cancer type

Glioblastoma

Biomarker criteria

Required: IDH1 wild-type

Required: IDH2 wild-type

Disease stage

Required: Stage GRADE IV

Grade: iv (who)

Prior therapy

Must have received: radiation therapy — recurrent GBM

at a minimum radiation therapy (RT) [required for recurrent disease]

Cannot have received: prolifeprospan 20 with carmustine wafer (carmustine)

Prior prolifeprospan 20 with carmustine wafer

Cannot have received: intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent

Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent

Cannot have received: radiation therapy for GBM or lower-grade glioma

Prior radiation treatment for GBM or lower-grade glioma [excluded for newly diagnosed]

Cannot have received: chemotherapy for GBM or lower-grade glioma

Prior chemotherapy or immunotherapy for GBM or lower-grade glioma [excluded for newly diagnosed]

Cannot have received: immunotherapy for GBM or lower-grade glioma

Prior chemotherapy or immunotherapy for GBM or lower-grade glioma [excluded for newly diagnosed]

Cannot have received: concurrent active therapy for GBM outside of the trial

Receiving additional, concurrent, active therapy for GBM outside of the trial

Cannot have received: lomustine (lomustine)

any prior treatment with lomustine

Cannot have received: experimental agents (any of the experimental arms)

agents part of any of the experimental arms

Cannot have received: bevacizumab or other VEGF or VEGF receptor-mediated targeted agent (bevacizumab)

bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent

Structured fields extracted by AI. May contain errors — verify against the official protocol.

What participants and caregivers reported

One account found in public discussions of this study. These are individual experiences, not study results.

Screening · Travel · Not knowing the assignment · Visit schedule · Making the decision

Caregiver · University of Miami · June 2025 · Screening scheduled, not yet enrolled

A caregiver described the screening visit their family had been scheduled for the following week — blood work, a brain perfusion MRI, an ECG and consent paperwork. They wrote about weighing whether joining would delay chemoradiation, about the repeated drives to Miami this would mean, and about not knowing which arm their family member would be assigned to.

One person's experience · May be specific to this site · Describes planning, not treatment

Read the original ↗Reddit — r/glioblastoma

Why this was linked to NCT03970447

The post names GBM AGILE by name, describes its adaptive randomization, and identifies a site that runs it.

These are paraphrased from public posts and articles, each linked to its source. We check that a post is about this study, but we cannot verify what it describes. Nothing here is medical advice, and none of it should be read as evidence that a treatment works.

US trial sites

  • University of Alabama at Birmingham · Birmingham, Alabama
  • University of California, San Diego · La Jolla, California
  • Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute · Los Angeles, California
  • University of California, Los Angeles · Los Angeles, California
  • St. Joseph Hospital · Orange, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT03970447 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior prolifeprospan 20 with carmustine wafer, intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent, radiation therapy for GBM or lower-grade glioma disqualifies patients from enrollment.

Does this trial require IDH1?

Yes, IDH1 wild-type is a required biomarker for enrollment.

Does this trial require IDH2?

Yes, IDH2 wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage GRADE IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Glioblastoma trials