NBTS Brain Tumor Clinical Trials Report: Q2 2021

It can be hard to keep track of new clinical trial opportunities opening across the United States, especially as we continue to navigate the public health crisis created by the coronavirus (COVID-19). There are many clinical trials actively enrolling patients, and this report provides a summary of the studies that have recently opened or started for primary brain tumor patients*. To learn more about each trial, and to contact the party responsible for enrolling patients, just follow the hyperlink.**

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• Phase I Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
  • This is a phase I study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma.
    
• Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma
  • This phase I/II trial called “SJ901” will evaluate the brain-penetrant MEK inhibitor, mirdametinib (PD-0325901), in patients with pediatric low-grade glioma (pLGG).
    
• Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
  • In this phase II study, safety, response to treatment, and progression-free and overall survival will be evaluated for the drug ivosidenib in combination with nivolumab in patients with advanced solid tumors (unresectable or metastatic) or enhancing gliomas.
    
• A Pilot Study of Larotectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion 
  • This is a pilot study (early phase I trial) called “CONNECT1903” that will evaluate disease status in children that have been newly diagnosed with high-grade glioma with TRK fusions. The evaluation will occur after 2 cycles of the medication larotrectinib have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy as well as the safety of larotrectinib when given post-focal radiation therapy.
    
• Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma
  • The purpose of this phase I study is to investigate the impact of targeting immunosuppressive myeloid-derived suppressor cells (MDSCs) in newly diagnosed IDH-wildtype grade III-IV astrocytoma by combining tadalafil with standard of care radiation therapy (RT) and temozolomide (TMZ).
    
• A Study of Berubicin in Adults With Recurrent Glioblastoma 
  • This is a phase II trial to evaluate the survival benefits of recurrent glioblastoma patients receiving either the drug berubicin or lomustine.

• AB154 Combined With AB122 for Recurrent Glioblastoma
  • This is a phase 0/I exploratory study for patients at first or second recurrence of glioblastoma to evaluate the effects of a treatment combination with the drugs AB154 and AB122 on patient tumors and tumor microenvironments.
    
• Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
  • This phase I/II trial studies the effect of the investigational drug NGM707 alone and in combination with the immunotherapy pembrolizumab for patients with advanced or metastatic solid tumor malignancies, including glioblastoma.
    
• Surgical Resection of Latent Brain Tumors Prior to Recurrence
  • This clinical trial evaluates the side effects and possible benefits of operating on brain tumors prior to the tumor coming back (recurrence) and to compare outcomes of those who have surgery after chemotherapy or radiation, but prior to tumor recurrence, to those who have surgery at a different time, or no surgery at all.
    
• Non-Invasive Focused Ultrasound (FUS) With Oral Panobinostat in Children With Progressive Diffuse Midline Glioma (DMG)
  • The primary purpose of this phase I study is to evaluate the feasibility of safely opening the blood-brain barrier in children with progressive diffuse midline gliomas (DMG) treated with oral panobinostat using focused ultrasound with microbubbles and neuro-navigator-controlled sonication.
    
• Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma
  • The purpose of this phase I study is to determine the safety and efficacy of the combination therapy of TTFields + SRS+ temozolomide (TMZ) for newly diagnosed glioblastoma (GBM) patients.
    
• Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors
  • This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors.
    
• CBT for Insomnia in Primary Brain Tumor Patients
  • The purpose of this phase II study is to evaluate the use of Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. 

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Below is a list of phase III clinical trials that are currently enrolling patients as recorded at the close of 2020. 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

• A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM AGILE)
• Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
• Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma
• Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma (MEN-301)
• Study to Evaluate Eflornithine + Lomustine vs. Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR STUDY)
• A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma
  • A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
  • A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma
• Study of Tozuleristide and the Canvas Imaging System in Pediatric Subjects With CNS Tumors Undergoing Surgery
• 131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases

Phase III Clinical Trials with Prior/Known Agents

• A Study Comparing Two Carboplatin Containing Regimens for Children and Young Adults With Previously Untreated Low-Grade Glioma
• Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low-Grade Glioma
• Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma
• Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma (CSCRGBM)
• Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
• A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1

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

**For additional navigation support, you can access NBTS’s Personalized Support and Navigation program by emailing patientnavigator@braintumor.org. Our patient navigator, Mary Lovely, PhD, RN, CNRN, has more than 30 years of experience working closely with brain tumor patients and families as a neurological nurse, clinical nurse specialist, and research nurse.
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TAGGED WITH: pediatric brain tumor, Ependymoma, neurosurgery, Clinical trials, immunotherapy, DIPG, precision medicine, meningioma, Treatment, pediatrics, Medulloblastoma, low-grade glioma, high-grade glioma, chemotherapy, glioblastoma, GBM, Oligodendroglioma, oligo, pharmaceutical companies, brain tumor, brain cancer

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