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NBTS Brain Tumor Clinical Trials Report: Q4 2019 (Including Year-End Update on Phase III Trials)

Brain tumor clinical trials open around the country all the time, and it can be hard for patients and care partners to keep track of new opportunities to consider participation in leading-edge clinical research. This report, generated by the National Brain Tumor Society, provides a summary of clinical trials that have started or begun recruitment since our last quarterly report. To learn more about each trial, and contact the party responsible for enrolling patients, just follow the link provided under the brief description of each listing.

  • Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
    • Brief Description: A phase III, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of AG-881 to placebo in participants will residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment.
    • LINK
  • WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases
    • Brief Description: A phase I trial studies the side effects and best dose of WSD0922-FU for the treatment of glioblastoma, anaplastic astrocytoma, or non-small cell lung cancer that has spread to the central nervous system (central nervous system metastases). WSD0922-FU is a targeted treatment that blocks the EGFR protein.
    • LINK
  • Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors
    • Brief Description: A phase I study to determine if B7H3-specific CAR T cells delivered via a catheter directly into the brain is a viable immunotherapy strategy for DIPG patients.
    • LINK
  • Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma
    • Brief Description: A phase I study to evaluate whether new metabolic imaging will be useful to physicians and patients with glioblastoma for making treatment decisions and seeing how well various types of treatment work. The goal is to improve the way patient care is managed in the future.
    • LINK
  • IL13Ralpha2-Targeted Chimeric Antigen Receptor (CAR) T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With Recurrent or Refractory Glioblastoma
    • Brief Description: A phase I trial to study the side effects and how well IL13Ralpha2-targeted CAR T cells work when given alone or together with nivolumab and ipilimumab in treating patients with glioblastoma that has come back or does not respond to treatment.
    • LINK
  • Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma (I-ATTAC)
    • Brief Description: A single-arm phase II study of cytomegalovirus pp65-loaded dendritic cells (DCs) immunotherapy for newly-diagnosed WHO Grade IV glioblastoma patients who have undergone definitive tumor resection, are unmethylated, and completed standard chemoradiation treatment.
    • LINK
  • TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
    • Brief Description: A phase II, open-label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.
    • LINK
  • Trial of C134 in Patients With Recurrent GBM (C134-HSV-1)
    • Brief Description: A phase I trial to obtain safety information in small groups of individuals, scheduled to receive escalating doses of C134, a cancer-killing virus (HSV-1) that has been genetically engineered to safely replicate and kill glioma tumor cells.
    • LINK
  • Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
    • Brief Description: This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high-grade glioma who have a genetic change called BRAF V600 mutation.
    • LINK 
  • A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
    • Brief Description: A phase I/II trial that will evaluate the safety and tolerability at different dose levels of repotrectinib (TPX-0005) in pediatric and young adult subjects with advanced cancers harboring ALK, ROS1, or NTRK alterations.
    • LINK
  • Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High-Grade Gliomas
    • Brief Description: A small, randomized, placebo-controlled pilot study to explore the effects of hydrogen-rich water on the quality of life in patients with high-grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with temozolomide.
    • LINK
  • A Study of PRT811 in Participants With Advanced Solid Tumors, Gliomas and Myelofibrosis
    • Brief Description: A phase I trial studying the investigational drug PRT811 in patients with advanced cancers, including high-grade gliomas, who have exhausted available treatment options. The purpose of this study is to define a safe dose and treatment schedule for PRT811.
    • LINK
  • A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma
    • Brief Description: This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatine/vincristine (CV) for subjects with NF1-associated low-grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth.
    • LINK
  • Non-Viral TCR Gene Therapy
    • Brief Description: A phase II trial to learn if a person’s white blood cells modified with T-cell receptors can cause solid tumors, including glioblastoma, to shrink.
    • LINK

Below is a list of phase III clinical trials that are currently enrolling patients as recorded at the close of 2018 (see our mid-year report here). A phase III clinical trial is traditionally the last, pivotal step in the evaluation of a potential new medicine before it is approved for use by all patients with the indicated disease.

Many of these are trials of a “novel/investigational agent” – meaning it is the first time a particular treatment is being tried for brain tumor patients. There are also a number of trials with therapies already in use for some brain tumor patients, for which researchers are evaluating these existing treatments in different combinations, different dosing regimens, and/or specific subgroups of patients.

Phase III Clinical Trials with Novel/Investigational Agents

Phase III Clinical Trials with Prior/Known Agents

*For a more comprehensive list of ALL open brain tumor clinical trials, please visit the NBTS Clinical Trial Finder at, where you can search potential opportunities for enrollment based on criteria important and specific to you.

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