Glioblastoma MultiformePhase 2RESTORENCT03862430
A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM
A Phase 2 study testing NanO2TM in people with Glioblastoma Multiforme, run by NuvOx LLC at 12 sites in United States.
Trial summary
This clinical trial is testing the safety and efficacy of NanO2TM administered via intravenous infusion in combination with standard radiation and chemotherapy. NanO2TM is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- NanO2TM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Mar 2023to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme.
- Treatment plan includes 60 Gy of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
- Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator).
- Aged 18 years and older.
- Karnofsky Performance Status ≥ 70
- Life expectancy of at least 3 months.
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- Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
- Baseline MRI performed within 7 days before starting study treatment while on a stable or decreasing glucocorticoid dose for at least 7 days before and during the imaging study.
- Adequate hematologic, renal and hepatic function, as defined by:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 75 x 109/L
- Hemoglobin ≥ 10.0 g/dl
- Serum creatinine < 1.5 x ULN
- Total bilirubin within normal limits (≤ 2.5 x ULN if Gilbert's syndrome)
- Aspartate transaminase (AST) and Alanine transaminase (ALT) < 2.5 x ULN
- Women of childbearing potential or men with child-bearing potential partners (unless vasectomized) must agree to use a highly-effective method of birth control from study entry until 4 months after completing study therapy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Recurrent Glioblastoma
- Prior treatment for glioblastoma apart from surgical resection.
- Presence of multi-focal glioblastoma disease that cannot be encompassed into a radiation treatment field that would be safely treated to the prescribed radiation dose.
- Presence of leptomeningeal disease that cannot be encompassed within a feasible and safe radiation field.
- Intracranial bleeding, except for stable grade 1 hemorrhage or a post-operative bleed that is clearing.
- Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
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- Subjects who have received any other investigational agent within 4 weeks before enrollment
- Stroke or transient ischemic attack requiring hospitalization within 6 months before enrollment.
- Myocardial infarction (MI) within 6 months before enrolment, unstable angina, New York Heart Association (NYHA) class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg).
- Known History of Congenital long QT syndrome (12-lead EKG is not required).
- Clinically significant chronic obstructive pulmonary disease or asthma.
- Active major infection requiring treatment.
- A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancers or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
- Known infection with human immunodeficiency virus or hepatitis B or C virus (testing is not required).
- Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins, low-dose aspirin, rivaroxaban (Xarelto®), apixaban (Eliquis®), or dabigatran (Pradaxa®).
- History of allergic reactions attributed to compounds of similar chemical composition to NanO2.
- Women who are pregnant or breast feeding.
- Inability to comply with study procedures.
- History or evidence of any other clinically significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion.
- Known hypersensitivity to any temozolomide component or to dacarbazine (DTIC).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Yale Cancer Center
New Haven, Connecticut, 06520
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
UC Irvine Health- Chao Family Comprehensive Cancer Center
Orange, California, 92868
St. Francis Medical Center, OSF Healthcare
Peoria, Illinois, 61637
Providence St. John's Cancer Institute
Santa Monica, California, 90404
Atlantic Health System
Summit, New Jersey, 07901
Center for Neurosciences
Tucson, Arizona, 85718
University of Arizona
Tucson, Arizona, 85719
About this study
Official title: A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE
This clinical trial is testing the safety and efficacy of NanO2TM administered via intravenous infusion in combination with standard radiation and chemotherapy.
NanO2TM is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.
Read the detailed description
All study participants will receive standard care for GBM including Temozolomide and radiation therapy. Subjects will be randomized on a 2 to 1 basis to receive either NanO2 infusions or saline infusions immediately prior to standard radiation therapy. Radiation therapy is performed 5 days a week for 6 weeks.
Radiation therapy is followed 28 days of recovery, and then six cycles of maintenance Temozolomide therapy on days 1 to 5 of six 28 day cycles.
Follow up will be every 3 months for 3 years, and then every 6 months for another 2 years.
- Conditions
- Glioblastoma Multiforme
- Being tested
- NanO2TM, Placebo Saline Infusion
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanO2TMDrug
Also called Dodecafluoropentane emulsion (DDFPe)
0.1 mL/kg NanO2 infusion
Placebo Saline InfusionDrug
Also called 0.9N NaCl
Saline Infusion
| Study group | Role | What they receive |
|---|---|---|
| NanO2TM | Experimental | NanO2TM infusion in conjunction with Radiation Treatment and temozolomide Receives: Drug: NanO2TM |
| Placebo | Placebo comparator | Placebo Saline infusion in conjunction with Radiation Treatment and temozolomide Receives: Drug: Placebo Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
To determine progression free survival (PFS) in newly-diagnosed glioblastoma patients after treatment with NVX-108 in combination with radiation and temozolomide (TMZ)
Measured: 22 months
Secondary outcomes (7)
Overall Survival
To determine overall survival (OS) in newly-diagnosed glioblastoma patients after treatment with NanO2TM at the RD in combination with radiation and temozolomide.Neuro-oncology (RANO) criteria
Measured: 22 Months
Response assessment by mRANO
To determine the objective response rate to study therapy using the modified Response Assessment in Neuro-oncology (mRANO) criteria
Measured: 22 Months
Response assessment for pseudoprogression
To determine the effect of NanO2 on the timing of pseudoprogression occurrence
Measured: 22 Months
To confirm that NanO2 re-oxygenation
Via TOLD MRI, we measure the oxygenation level in tumor tissue, to confirmd NanO2 treatment causes the re-oxygenation of hypoxic tissue
Measured: 22 Months
To estimate the effect on the duration of functional independence
To estimate the effect on the duration of functional independence, as measured by the periodic measurement of Karnofsky Performance Scale
Measured: 22 Months
Patient quality of life
To measure NanO2 treatment's impact on patient quality of life (score) by using FACT-Br
Measured: 22 Months
Caregiver quality of life
To measure NanO2 treatment's impact on caregiver quality of life (score) by using questionnaires form CQOLC
Measured: 22 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start31 Mar 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuvOx LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862430
- Sponsor's protocol ID
- RESTORE-P2
- Acronym
- RESTORE
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE
- ClinicalTrials.gov ID
- NCT03862430
- Acronym / sponsor ID
- RESTORE / RESTORE-P2
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- NuvOx LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is testing the safety and efficacy of NanO2TM administered via intravenous infusion in combination with standard radiation and chemotherapy.
NanO2TM is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.
Detailed description
All study participants will receive standard care for GBM including Temozolomide and radiation therapy. Subjects will be randomized on a 2 to 1 basis to receive either NanO2 infusions or saline infusions immediately prior to standard radiation therapy. Radiation therapy is performed 5 days a week for 6 weeks.
Radiation therapy is followed 28 days of recovery, and then six cycles of maintenance Temozolomide therapy on days 1 to 5 of six 28 day cycles.
Follow up will be every 3 months for 3 years, and then every 6 months for another 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanO2TM | Experimental | Drug: NanO2TMNanO2TM infusion in conjunction with Radiation Treatment and temozolomide |
| Placebo | Placebo comparator | Drug: Placebo Saline InfusionPlacebo Saline infusion in conjunction with Radiation Treatment and temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed, newly diagnosed primary or secondary glioblastoma multiforme.
- Treatment plan includes 60 Gy of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
- Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator).
- Aged 18 years and older.
- Karnofsky Performance Status ≥ 70
Key exclusion criteria (20 listed)
- Recurrent Glioblastoma
- Prior treatment for glioblastoma apart from surgical resection.
- Presence of multi-focal glioblastoma disease that cannot be encompassed into a radiation treatment field that would be safely treated to the prescribed radiation dose.
- Presence of leptomeningeal disease that cannot be encompassed within a feasible and safe radiation field.
- Intracranial bleeding, except for stable grade 1 hemorrhage or a post-operative bleed that is clearing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanO2TMAlso: Dodecafluoropentane emulsion (DDFPe)0.1 mL/kg NanO2 infusion | Drug | NanO2TM |
| Placebo Saline InfusionAlso: 0.9N NaClSaline Infusion | Drug | Placebo |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 22 months
To determine progression free survival (PFS) in newly-diagnosed glioblastoma patients after treatment with NVX-108 in combination with radiation and temozolomide (TMZ)
7 secondary outcomes
Overall Survival
Time frame: 22 Months
Response assessment by mRANO
Time frame: 22 Months
Response assessment for pseudoprogression
Time frame: 22 Months
To confirm that NanO2 re-oxygenation
Time frame: 22 Months
To estimate the effect on the duration of functional independence
Time frame: 22 Months
Patient quality of life
Time frame: 22 Months
Caregiver quality of life
Time frame: 22 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NanO2TM in people with Glioblastoma Multiforme, run by NuvOx LLC at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.