Nativis Voyager for Newly Diagnosed GBM (NAT109)
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ClinicalTrials.gov Identifier: NCT03276286 |
Recruitment Status : Unknown
Verified August 2019 by Nativis, Inc..
Recruitment status was: Active, not recruiting
First Posted : September 8, 2017
Last Update Posted : August 20, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Multiforme | Device: Nativis Voyager | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Nativis Voyager combined with standard radiotherapy and temozolomide |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) |
Actual Study Start Date : | November 10, 2017 |
Estimated Primary Completion Date : | January 31, 2020 |
Estimated Study Completion Date : | January 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Nativis Voyager
Nativis Voyager combined with SOC Radiotherapy and temozolomide
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Device: Nativis Voyager
Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide |
- Treatment-related Adverse Events (Safety) [ Time Frame: Through study completion, average of 1 year ]Safety as measured by number of investigational treatment-related adverse events as assessed by CTCAE v4.0.
- Clinical Utility PFS [ Time Frame: 6 months ]Progression Free Survival
- Clinical Utility OS [ Time Frame: Through patient completion, expected average 8 months ]Overall Survival

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276286
United States, Arizona | |
Center for Neurosciences | |
Tucson, Arizona, United States, 85718 | |
United States, California | |
California Cancer Care Associates | |
Encinitas, California, United States, 92024 | |
John Wayne Cancer Institute @ Providence St Johns Health Center | |
Santa Monica, California, United States, 90404 | |
United States, Connecticut | |
Associated Neurologists of Southern CT, PC | |
Fairfield, Connecticut, United States, 06824 | |
United States, Florida | |
Boca Raton Regional Hospital | |
Boca Raton, Florida, United States, 33486 | |
United States, Texas | |
Cancer Care Collaborative | |
Austin, Texas, United States, 78705 | |
Baylor Scott and White Health | |
Temple, Texas, United States, 98101 |
Study Chair: | Donna Morgan Murray, PhD | Nativis, Inc. |
Responsible Party: | Nativis, Inc. |
ClinicalTrials.gov Identifier: | NCT03276286 |
Other Study ID Numbers: |
NAT109 |
First Posted: | September 8, 2017 Key Record Dates |
Last Update Posted: | August 20, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |