Nativis Voyager for Newly Diagnosed GBM (NAT109)

A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)

This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.

Study Overview

• Status: Completed
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Device: Nativis Voyager

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • California
    • Encinitas, California, United States, 92024
      • California Cancer Care Associates
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute @ Providence St Johns Health Center
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern CT, PC
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Cancer Care Collaborative
    • Temple, Texas, United States, 98101
      • Baylor Scott and White Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• There is pathological evidence of GBM using World Health Organization (WHO) classification.
• Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
• Subject must have at least one measurable lesion per RANO.
• Subject is at least 18 years of age.
• Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
• Subject has life expectancy > 3 months.
• Subject has adequate organ and marrow function; see note 1.
• Subject able to start treatment at least 28 days from tumor resection surgery.
• Subject has provided signed informed consent.

Exclusion Criteria:

• Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
• Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• Subject is currently being treated with Optune.
• Subject is currently being treated with other investigational agents.
• Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
• Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
• Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
• Subject has a clinically significant electrolyte abnormality.
• Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI. Subjects with programmable shunt are excluded from the study.
• Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
• Subject is known to be HIV positive.
• Subject is pregnant, nursing or intends to become pregnant during the study period.
• Subject is participating in other potentially confounding investigational research.
• Subject has any condition that at the discretion of the investigator would preclude participation in the study.
• Subject is unable or unwilling to comply with the protocol-required follow-up schedule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nativis Voyager; Nativis Voyager combined with SOC Radiotherapy and temozolomide	Device: Nativis Voyager; Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related Adverse Events (Safety)	Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.	Through study completion, average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Utility PFS	Progression Free Survival	6 months
Clinical Utility OS	Overall Survival	Through patient completion, expected average 8 months

Collaborators and Investigators

• Sponsor: Nativis, Inc.
• Investigators: Study Chair: Donna Morgan Murray, PhD, Nativis, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2017
• Primary Completion (ACTUAL): May 31, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: NAT109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes