Back to search results

Trial for Newly Diagnosed and Recurrent Glioblastoma

This study is evaluating several treatments for glioblastoma (a type of brain cancer) in people who are newly diagnosed or whose cancer has returned. The treatments being tested include Temozolomide, Lomustine, Regorafenib, Paxalisib, and radiation. The study aims to find effective therapies and match them to specific patient types. Researchers will measure how long participants live (Overall Survival) to see if the treatments are successful. This trial is designed to efficiently test new therapies, and new drugs may be added over time. You may be able to join if you are 18 or older and have a confirmed diagnosis of Grade IV glioblastoma.

Study design
This is an international, adaptive Phase II/III platform trial designed to evaluate multiple therapies. It plans to enroll 2250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be measured from the date of randomization until death, or until 12 months after the last patient is randomized (approximately 2 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03970447

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Global Coalition for Adaptive Research
~2,250 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:TemozolomideLomustineRegorafenibRadiationPaxalisibVAL-083

At a glance

Recruiting sites
40 of 63 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over From date of randomization until the date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

Conditions

Glioblastoma

Explore related trials

Glioblastoma

Where it's being run

63 sites across 32 states
California6
Germany6
New York4
Florida3
Ohio3
Pennsylvania3
Texas3
France3

Study leadership

  • Tim Cloughesy, MD · PRINCIPAL_INVESTIGATOR · GCAR CMO and GBM AGILE Global PI

Who to contact

Patient Information
[email protected]
310-598-3199
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Overall Survival (OS)From date of randomization until the date of death from any cause, or until 12 months following last patient randomization (approximately 2 years), whichever comes first.

    Overall survival is defined from the time of randomization to death from any cause. Patients still alive at the time of an analysis will be considered censored at their date of last contact.