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    Clinical Trial Results:
    PHASE II STUDY OF NEOADJUVANT NIVOLUMAB IN PATIENTS WITH GLIOBLASTOMA MULTIFORME

    Summary
    EudraCT number
    		 2015-000442-39
    Trial protocol
    		 ES  
    Global end of trial date
    01 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Sep 2021
    First version publication date
    30 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Neo-Nivo
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02550249
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clínica Universidad de Navarra
    Sponsor organisation address
    Avda. Pío XII,36, Pamplona, Spain, 31008
    Public contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400 2723, ucicec@unav.es
    Scientific contact
    UCEC, Clinica Universidad de Navarra, 34 948 255 400 2723, ucicec@unav.es
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess changes in PD-L1 and CD8 expression induced by neoadjuvant nivolumab in GBM. For that purpose we will compare GBM tissue of patients before and after treatment with neoadjuvant nivolumab.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    22
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were offered participation in the trial in the neouroncology clinics of University of Navarra.

    Pre-assignment
    Screening details
    		 Patients over 18 years with GBM that are candidates to primary or salvage resection surgery. In patients undergoing primary surgery, diagnosis of GBM should be confirmed by previous biopsy or previous partial resection. in patients with recurrent GBM, diagnosis of progression will be confirmed either by previous biopsy or by the RANO criteria.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental group
    Arm description
    		 Patients from two subgroups were recruited to the study; patients who required salvage surgery to treat relapsed disease (n = 27) as well as patients who required surgery for primary tumor resection (n = 3) were recruited. These patients were administered a 3mg/kg dose of nivolumab. 2 weeks after nivolumab administration they underwent surgery. Patients received postsurgical doses of nivolumab every 2 weeks progression or unacceptable toxicity. For the three patients who underwent primary surgical treatment, nivolumab was stopped to receive standard-of-care chemoradiotherapy (CRT). In two of these cases, nivolumab was reintroduced following completion of chemoradiotherapy. These patients have not relapsed and they remain on nivolumab maintenance therapy without toxicity
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    BMS-936558
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    weeks (± 3 days) before the surgery. Patients received postsurgical doses of nivolumab every 2 weeks (± 3 days) until radiologic progression or unacceptable toxicity.

    Number of subjects in period 1
    		Experimental group
    Started
    30
    Completed
    29
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 22 22
        From 65-84 years
    		 8 8
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    		 Patients from two subgroups were recruited to the study; patients who required salvage surgery to treat relapsed disease (n = 27) as well as patients who required surgery for primary tumor resection (n = 3) were recruited. These patients were administered a 3mg/kg dose of nivolumab. 2 weeks after nivolumab administration they underwent surgery. Patients received postsurgical doses of nivolumab every 2 weeks progression or unacceptable toxicity. For the three patients who underwent primary surgical treatment, nivolumab was stopped to receive standard-of-care chemoradiotherapy (CRT). In two of these cases, nivolumab was reintroduced following completion of chemoradiotherapy. These patients have not relapsed and they remain on nivolumab maintenance therapy without toxicity

    Primary: Overall Survival (OS) and Progression-free survival (PFS)

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    End point title
    		 Overall Survival (OS) and Progression-free survival (PFS) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Throughout the trial.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Overall survival (O) and progression-free survival (PFS) were determined by the Kaplan-Meier method. There is no comparison between groups since there is only one arm in the trial design.
    End point values
    		 Experimental group
    Number of subjects analysed
    29
    Units: Months
    median (confidence interval 95%)
        OS
    7.3 (5.4 to 7.9)
        PFS
    4.1 (2.8 to 5.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All non-SAE should be collected during the treatment period and for a minimum of 100 days following the last dose of study treatment.All SAEs must be collected that occur during the screening period and within 100 days of discontinuation dosing.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 BMS
    Dictionary version
    ND
    Reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor bleeding
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Liver function tests
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Experimental group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 30 (16.67%)
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hepatobiliary disorders
    Liver function tests
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Endocrine disorders
    Autoimmune primary hyperthyroidism
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30742120
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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