Clinical Trials Round Up: May 2018

We are very excited to announce a new clinical trial for the assessment and treatment of patients with newly diagnosed glioblastoma, by trial creator and principal investigator, Santosh Kesari, MD, PhD.

This brain cancer study, Precision Immunotherapy in the Neoadjuvant Setting (PIN), provides alternative immunotherapy options to the current standard of care treatment that patients receive when presenting with a new diagnosis of glioblastoma.

This new clinical trial tackles glioblastoma treatment in a whole new way. By giving immunotherapy first rather than radiation and chemotherapy, the patient’s immune system remains uncompromised which could result in better responses and lead to better patient outcomes.

1. New Studies

 

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer (NCT03425292)

This is a randomized, longitudinal assessment of tumor evolution in patients with newly diagnosed glioblastoma. Study is designed to assess the safety and tolerability of administering nivolumab versus nivolumab in combination with ipilimumab prior to radiation therapy. The study will also collect biological specimens before, during, and after treatments to identify determinants of response and safety. Parallel assessment of the effect of standard radiation and temozolomide on tumor microenvironment will provide a deeper understanding of tumor stratification for precision medicine.

 

2. Actively Recruiting Studies

 

Brain Cancer (Primary)

Boehringer Ingelheim (PDF): A Phase I Dose Escalation and CNS Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients with Recurrent or Progressive Brain Cancer (NCT02423525)

Boston Biomedical (PDF): A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients WithRecurrent or Progressive Glioblastoma (GBM) Following Initial Therapy (NCT03149003)

Caris (PDF): Caris Molecular Intelligence Repository

Medicenna Therapeutics, Inc. (PDF): An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma (NCT02858895)

Nativis 101 (PDF): A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM) (NCT02296580)

Nativis 109 (PDF): A Feasibility Study of the Nativis Voyager System in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM) (NCT03276268)

NovoCure, Ltd. (PDF) A Single-Center, Open-Label, Randomized Phase II Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas (NCT02507232)

Orbus Therapeutics (PDF): A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy (NCT02796261)

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): Neurological Outcomes in Health and Disease

Triphase MRZ-112 (PDF): Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer (NCT02903069)

 

Brain Metastasis

Boehringer Ingelheim (PDF): A Phase I Dose Escalation and CNS Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients with Recurrent or Progressive Brain Cancer (NCT02423525)

Eli Lilly and Company (PDF): A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma (NCT02308020)

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): Neurological Outcomes in Health and Disease

 

Solid Tumors

Caris (PDF): Caris Molecular Intelligence Repository

Incyte Corporation: A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors (NCT02646748)

 

Quality and Outcomes Research

CancerLife2 (PDF): CancerLife: Patient-Driven Solution in Cancer Care (NCT03371147)

Family Caregivers (PDF): An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients(NCT03069105)

 

3. Not Recruiting/Recently Closed Studies

 

Neurology

SanBio, Inc. (PDF): Study of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (NCT02416492). This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from traumatic brain injury.

SanBio, Inc. / Sunovion (PDF): A Double-Blind, Controlled Phase 2b Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (NCT02448641). This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke.

 

Neuro-Oncology

AbbVie / RTOG: A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (NCT02646748)

CancerLife (PDF): Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study(NCT03094741)

EpiCentRX: Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases (BRAINSTORM) (NCT02215512)

ImmunoCellular: A Phase III Randomized Double-Blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma following Resection and Concomitant TMZ Chemoradiotherapy (NCT02546102)

Inspyr Therapeutics: Efficacy, Safety and CNS Exposure of G-202 in Patients with PSMA-Positive Recurrent or Progressive Glioblastoma (NCT02876003)

Kadmon: Study of Tesevatinib in Subjects With Non-Small Cell Lung Cancer, EGFR Activating Mutation, Prior Treatment With a Tyrosine Kinase Inhibitor, and Brain Metastases or Leptomeningeal Metastases (NCT02616393)

Triphase MRZ-108: Phase 2 Trial of Single Agent Marizomib in Progressive or Recurrent Grade IV Malignant Glioma(NCT02330562)

 

Investigators:

Achal S. Achrol, MD
Garni Barkhoudarian, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Steven O’Day, MD
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN

Clinical Trials Team:

Najee Boucher, CRA, najee.boucher@providence.org, phone 310-582-7460
Jaya M. Gill, RN., BSN, jaya.gill@providence.org, phone 310-582-7437
Annie Heng, RN, BSN, HengA@jwci.org, phone 310-582-7457
Tiffany Juarez, PhD, tiffany.juarez@jwci.org , phone 310-449-5225
Anand Moses, CRA, MosesA@jwci.org, phone 310-582-7097

                                                                                                                           

For more information, please explore the hyperlinks or contact the Neuro-Oncology Clinical Trial Team at: e-mail: neuro.oncology@jwci.org  |  phone: 310-829-8265