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NBTS Brain Tumor Clinical Trials Report: Q4 2018 (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.


  • REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma
    • Brief Description: A Phase I/II to confirm the safety, anticipated dose, and anti-tumor activity of the PD-1 inhibitor REGN2810 (cemiplimab) for children with recurrent or refractory solid or CNS tumors (including DIPG), given in a variety of combinations and timing.
    • LINK: https://bit.ly/2VjixZQ 
  • A Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
    • Brief Description: A Phase I/II study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
    • LINK: https://bit.ly/2EQDFB8
  • Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas
    • Brief Description: A first-in-pediatrics study to examine the safety, tolerability, and pharmacokinetics of GDC-0084 and to estimate its maximum tolerated dose (MTD) when administered to pediatric patients with diffuse intrinsic pontine glioma (DIPG) or other diffuse midline H3 K27M-mutant gliomas after they have received radiation therapy (RT). This study is also designed to enable a preliminary assessment of the antitumor activity of single-agent GDC-0084, in the hope of enabling rational combination therapy with systemic therapy and/or radiation therapy (RT) in this patient population.
    • LINK: https://bit.ly/2GKEAFU
  • Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
    • Brief Description: A phase II trial to study how well whole brain radiation therapy works with standard temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma.
    • LINK: https://bit.ly/2QVXEW7
  • Veliparib, Radiation Therapy and Temozolomide in Treating Participants With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600E Mutations
    • Brief Description: A phase II trial to study how well veliparib, radiation therapy, and temozolomide work in treating participants with newly diagnosed malignant glioma without H3 K27M or BRAFV600E mutations.
    • LINK: https://bit.ly/2RoELKY 
  • 9-ING-41 in Patients With Advanced Cancers
    • Brief Description: The Actuate 1801 trial is a phase I/II study to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers, including malignant gliomas.
    • LINK: https://bit.ly/2VgkCpG
  • EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors
    • Brief Description: This is a phase I study of the feasibility, safety, and tolerability of CAR T cells administered by catheter into the tumor resection cavity or the ventricular system in children and young adults with recurrent or refractory EGFR-positive CNS tumors.
    • LINK: https://bit.ly/2EVd0UI
  • Volitinib in Treating Participants With Recurrent or Refractory Primary CNS Tumors
    • Brief Description: This phase I trial studies the best dose and side effect of volitinib in treating participants with primary central nervous system (CNS) tumors that have come or does not respond to treatment.
    • LINK: https://bit.ly/2ViaFIq
  • Feasibility of Individualized Therapy for Recurrent GBM
    • Brief Description: This phase I trial will test the ability and likelihood of successfully implementing individualized combination treatment recommendations for adult patients with surgically-resectable recurrent glioblastoma in a timely fashion. Collected tumor tissue and blood will be examined using new diagnostic testing called UCSF 500 Cancer Gene Panel which is done at the UCSF Clinical Cancer Genomics Laboratory. The UCSF 500 Cancer Gene Panel will help identify genetic changes in the DNA of a patient’s cancer, which helps oncologists improve treatment by identifying targeted therapies.
    • LINK: https://bit.ly/2EUzu82 
  • Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
    • Brief Description: This phase II Pediatric MATCH trial studies how well ulixertinib works in treating patients with advanced solid tumors, including malignant gliomas, that have a genetic alteration (mutation) in a signaling pathway called MAPK.
    • LINK: https://bit.ly/2LFd5fE 
  • Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma
    • Brief Description: This phase II study is being done to see if adding nivolumab to radiation therapy and bevacizumab can increase the effectiveness of the treatment for recurrent glioblastoma.
    • LINK: https://bit.ly/2EWu2Si 
  • Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
    • Brief Description: A phase II trial is studying pembrolizumab and re-irradiation as possible treatments for glioblastoma.
    • LINK: https://bit.ly/2LIk6wo 
  • Multi-antigen T Cell Infusion Against Neuro-oncologic Disease (REMIND)
    • Brief Description: This phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs or recurrent, progressive, or refractory non-brainstem CNS malignancies.
    • LINK: https://bit.ly/2Q5KUqF
  • Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer
    • Brief Description: A phase I trial studying a novel drug called ALRN-6924 as a possible treatment for resistant (refractory) solid tumors, including brain tumors.
    • LINK: https://bit.ly/2CEjIMi
  • A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy
    • Brief Description: A phase I/II clinical trial of BMX-001, a new class of pharmaceutical, in patients with multiple brain metastases (MBM) undergoing whole brain radiation therapy (WBRT).
    • LINK: https://bit.ly/2Q8mQ6P
  • Phase I Study of Fractionated Stereotactic Radiation Therapy
    • Brief Description: A phase I study to determine the feasibility and safety of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases.
    • LINK: https://bit.ly/2SkCUEe

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 trials.braintumor.org, where you can search potential opportunities for enrollment based on criteria important and specific to you.

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