Previewing Six Glioma Clinical Trials Set to Complete in the United States

It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we are previewing six clinical trials focusing on gliomas that are anticipated to complete within the next few years. All trials are U.S.-based and the majority are still recruiting. While the initial trial listed has yet to begin recruiting, the others are all active.

Quick View Table of Glioma Clinical Trials

Featured Glioma Clinical Trials

Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma (Cerebraca-02/3)

• Sponsor: ​​Everfront Biotech
• Goal: This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition.
• Interventions: Cerebral wafer, temozolomide
• Primary Outcome Measure: Median overall survival (OS)
• Time Frame: 24 months
• Study Details
• Source

Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients

• Sponsor: Jonsson Comprehensive Cancer Center
• Goal: This phase III trial is evaluating whether a combination of three advanced magnetic resonance imaging (MRI) techniques, including chemical exchange saturation transfer (CEST) MRI, diffusion-relaxation correlation spectrum imaging (DR-CSI), and ferumoxytol-enhanced magnetic resonance imaging (Fe-MRI) are effective as non-invasive methods for assessing the cells and proteins that surround and interact with tumor cells (the tumor immune microenvironment) in patients with glioblastoma.
• Interventions: Biospecimen collection, chemical exchange saturation transfer magnetic resonance imaging, electronic health record review, diffusion-relaxation correlation spectrum imaging, ferumoxytol, magnetic resonance imaging.
• Primary Outcome Measures: Mean diffusion-relaxation correlation spectrum imaging (DR-CSI) value; Ferumoxytol-enhanced magnetic resonance imaging (Fe-MRI) measures; Chemical exchange saturation transfer (CEST) values.
• Time Frames: Perioperatively/periprocedurally; Perioperatively/periprocedurally; Perioperatively/periprocedurally.
• Study Details
• Source

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

• Sponsor: Ivy Brain Tumor Center
• Goal: The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM).
• Interventions: Niraparib, Temozolomide
• Primary Outcome Measure: Overall survival
• Time Frame: 24 months
• Study Details
• Source

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM (SONOBIRD)

• Sponsor: CarThera
• Goal: The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.
• Interventions: SonoCloud-9, carboplatin, lomustine, temozolomide
• Primary Outcome Measure: Overall survival
• Time Frame: Up to 24 months
• Study Details
• Source

DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/​FIREFLY-2)

• Sponsor: Day One Biopharmaceuticals
• Goal: This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.
• Interventions: Tovorafenib, chemotherapeutic agent
• Primary Outcome Measure: Objective response rate (ORR) of tovorafenib monotherapy versus SoC chemotherapy.
• Time Frame: Up to 60 months.
• Study Details
• Source

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) (ACTION)

• Sponsor: Jazz Pharmaceuticals
• Goal: This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following frontline radiotherapy will extend overall survival and progression-free survival in this population.
• Interventions: Dordaviprone (ONC201), dordaviprone (ONC201) + placebo, placebo
• Primary Outcome Measure: Overall survival
• Time Frame: From date of randomization until date of death from any cause, assessed up to approximately 44 months.
• Study Details
• Source

Related Guidelines:

• Treatment of Adults With WHO Grade II Diffuse Glioma
  • Congress of Neurological Surgeons (CNS)
  • April 2026

• Molecular Biomarker Testing for the Diagnosis of Diffuse Gliomas
  • College of American Pathologists (CAP)
  • February 2022

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