Glioblastoma MultiformePhase 2Neo-nivoNCT02550249
Neoadjuvant Nivolumab in Glioblastoma
A Phase 2 study testing Nivolumab in people with Glioblastoma Multiforme, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Neoadjuvant nivolumab will be administered to patients with primary and recurrent glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent.
- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study.
- Patients with GBM that are candidates to primary or salvage resection surgery, according to the following criteria:
- Patients may have received previous treatments for GBM. There is no limit on previous treatment lines, as long as the other inclusion criteria are met.
- Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator.
- Eastern Cancer Oncology Group (ECOG) performance status of 0-1. Patients with ECOG>1 due to neurological symptoms considered to be reversible following surgery, according to investigator´s criteria will be eligible
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- Life expectancy >12 weeks.
- Adequate organ function defined by:
- Bone Marrow Reserve: white blood cells (WBC): ≥2000/ mm3 absolute neutrophil count (ANC) ≥1500x 109/L; platelet count ≥100000/ mm3 100 x 109/L; hemoglobin ≥9.0 g/dL).
- Hepatic: bilirubin <1.5 times the upper limit of normality (ULN), AST and ALT <3.0 × ULN (BR< 3 x ULN for patients with Gilbert´s Syndrome).
- Renal: creatinine < 1.5 x ULN or estimated creatinine clearance > 40 ml/min, using the Cockcroft-Gault formula.
Who cannot join
- Presence of extracranial disease.
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive the planned therapy (including brain surgery), or interfere with the interpretation of study results.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Previous treatment with a PD-1, PDL1 or CTLA-4 targeted therapy
- Treatment with any anti-cancer drug or radiation therapy within the last 14 days. A shorter interval can be approved by the principal investigator, if deemed appropriate.
- Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents), with the exception of control of cerebral edema, or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
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- Pregnant or breastfeeding patients.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
- Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
- History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
- Prisoners or subjects who are involuntarily incarcerated or who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Subjects unable (due to existent medical condition, e.g, pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast enhanced MRI and/or a CT scan of the brain.
- Concomitant or prior malignancy that, in the opinion of the investigator contraindicates GBM surgery or can interfere with the results of the study, in the opinion of the investigator.
- Known drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Neoadjuvant Nivolumab in Patients With Glioblastoma Multiforme
Neoadjuvant nivolumab will be administered to patients with primary and recurrent glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery.
Read the detailed description
Neoadjuvant nivolumab will be administered to patients with primary and recurrent glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery until toxicity or progression.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Nivolumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Intravenous administration of nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab | Experimental | Nivolumab 3 mg every 2 weeks Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in percentage and level of expression of Programmed Death-Ligand 1 (PD-L1) by tumor cells and lymphocytes, assessed at baseline and following neoadjuvant nivolumab in Glioblastoma multiforme (GBM).
We will assess levels of expression of Programmed Death-Ligand 1 (PD-L1) by tumor cells and lymphocytes at baseline and following neoadjuvant nivolumab in Glioblastoma multiforme (GBM). The specific outcome will be the changes in these levels.
Measured: 1 neoadjuvant cycle followed by surgery (4 weeks). Evaluation will be performed at baseline and after the neoadjuvant cycle
Secondary outcomes (2)
Efficacy: response rate assessed by Response Assessment in Neuro-Oncology (RANO) criteria
Measured: 1 neoadjuvant cycle followed by surgery (4 weeks)
Safety: toxicity assessed by Common Toxicity Criteria (CTC) version 4
Measured: 1 neoadjuvant cycle followed by surgery (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2017
- Study completionMar 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignacio Melero, MD, PhD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550249
- Sponsor's protocol ID
- Neo-nivo
- Acronym
- Neo-nivo
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Nivolumab in Patients With Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT02550249
- Acronym / sponsor ID
- Neo-nivo / Neo-nivo
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Sep 2015 (estimated)
- 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.
Neoadjuvant nivolumab will be administered to patients with primary and recurrent glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery.
Detailed description
Neoadjuvant nivolumab will be administered to patients with primary and recurrent glioblastoma multiforme that require surgery. Nivolumab will be continued following surgery until toxicity or progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab | Experimental | Drug: NivolumabNivolumab 3 mg every 2 weeks |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent.
- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study.
- Patients with GBM that are candidates to primary or salvage resection surgery, according to the following criteria:
- Patients may have received previous treatments for GBM. There is no limit on previous treatment lines, as long as the other inclusion criteria are met.
- Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator.
Key exclusion criteria (14 listed)
- Presence of extracranial disease.
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive the planned therapy (including brain surgery), or interfere with the interpretation of study results.
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Previous treatment with a PD-1, PDL1 or CTLA-4 targeted therapy
- Treatment with any anti-cancer drug or radiation therapy within the last 14 days. A shorter interval can be approved by the principal investigator, if deemed appropriate.
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 |
|---|---|---|
| NivolumabAlso: OpdivoIntravenous administration of nivolumab | Drug | Nivolumab |
Primary outcome
Changes in percentage and level of expression of Programmed Death-Ligand 1 (PD-L1) by tumor cells and lymphocytes, assessed at baseline and following neoadjuvant nivolumab in Glioblastoma multiforme (GBM).
Time frame: 1 neoadjuvant cycle followed by surgery (4 weeks). Evaluation will be performed at baseline and after the neoadjuvant cycle
We will assess levels of expression of Programmed Death-Ligand 1 (PD-L1) by tumor cells and lymphocytes at baseline and following neoadjuvant nivolumab in Glioblastoma multiforme (GBM). The specific outcome will be the changes in these levels.
2 secondary outcomes
Efficacy: response rate assessed by Response Assessment in Neuro-Oncology (RANO) criteria
Time frame: 1 neoadjuvant cycle followed by surgery (4 weeks)
Safety: toxicity assessed by Common Toxicity Criteria (CTC) version 4
Time frame: 1 neoadjuvant cycle followed by surgery (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Ignacio Melero, MD, PhD principal investigator
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Glioblastoma Multiforme, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 11 inclusion and 14 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: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in percentage and level of expression of Programmed Death-Ligand 1 (PD-L1) by tumor cells and lymphocytes, assessed at baseline and following neoadjuvant nivolumab in Glioblastoma multiforme (GBM). (time frame: 1 neoadjuvant cycle followed by surgery (4 weeks). Evaluation will be performed at baseline and after the neoadjuvant cycle). 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 11 Apr 2017.