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    Clinical Trial Results:
    Avelumab as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers

    Summary
    EudraCT number
    		 2017-002758-35
    Trial protocol
    		 BE   FR  
    Global end of trial date
    05 Feb 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2026
    First version publication date
    05 Apr 2026
    Other versions
    Summary report(s)
    		 Avelumab-based neoadjuvant therapy in patients with muscle-invasive bladder cancer (AURA Oncodistinct-004): a phase 2 multicenter clinical trial

    Trial information

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    Trial identification
    Sponsor protocol code
    IJB-AURA-ODN-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ClinicalTrials.gov: NCT03674424
    Sponsors
    Sponsor organisation name
    Institut Jules Bordet
    Sponsor organisation address
    Rue Meylemeersch 90, Anderlecht, Belgium, 1070
    Public contact
    CTSU, Institut Jules Bordet, ctsu.trials@hubruxelles.be
    Scientific contact
    CTSU, Institut Jules Bordet, ctsu.trials@hubruxelles.be
    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
    19 Mar 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To assess the efficacy of Avelumab (anti-PD-L1) associated to different cytotoxic agents or in monotherapy in patients with non-metastatic MIBC as measured by the pathologic complete response rate (ypT0/Tis ypN0) following neoadjuvant treatment. Secondary objectives: *To determine the pathologic response rate (<ypT2N0) following neoadjuvant treatment in subjects with non-metastatic MIBC. *To assess the safety and tolerability of the regimens used *To assess the local or distant recurrence or secondary primary malignancy at 12 and 36 months after surgery (or at 12 and 36 months after last treatment dose for subject for whom no surgery was performed) *To assess the overall survival with 36 months of follow-up after completion of surgery (or after last treatment dose for subject for whom no surgery was performed).
    Protection of trial subjects
    This clinical study was implemented after evaluation by an independent French Committee for the protection of individuals (on 12/06/2018) and an independent Belgian Ethics Committee (on 28/05/2023). This biomedical research has been authorised by the French competent health authorities, the Agence Nationale de Sécurité des Médicaments et des Produits de Santé (ANSM) on 15/03/2019 and by the Belgian competent health authorities, the Federal Agency for medicines and health products (FAMHP) on 28/05/2023. Adhering to the principles of ICH-GCP, participants were thoroughly informed before inclusion. This encompassed details such as the voluntary nature of their participation, confidentiality, and protection of personal data, potential risk and benefits of participation, insurance coverage and the possibility of withdrawal at any time. The participants' informed consent was obtained freely, documented in writing, and personally signed and dated by each patient or by an authorized representative under applicable law. To protect privacy, subject names were not collected; instead, each participant received a unique sequential trial identification number upon registration. This identification number was used for referencing on all case report forms. Additionally, certain eligibility criteria were established for subjects to participate in the trial, with the aim of minimizing the risk of severe adverse events. The trial protocol included provisions for adjusting treatments in response to specific adverse events. Subjects had the freedom to withdraw from the clinical trial at any time, for any reason, and the study adhered to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines set forth by the European Union.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 66
    Country: Number of subjects enrolled
    France: 71
    Worldwide total number of subjects
    137
    EEA total number of subjects
    137
    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)
    48
    From 65 to 84 years
    89
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 *Actual start date of recruitment to the protocol: 13/07/2018 *Actual date stop date of recruitment to the protocol: 31/08/2021

    Pre-assignment
    Screening details
    		 Completion of all necessary screening procedures within 28 days prior to enrolment (unless specifically notified).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    None

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cisplatin - eligible : DD-MVAC + A
    Arm description
    		 Cisplatin-eligible subjects: Dose dense methotrexate, vinblastine, doxorubicin, cisplatin (DD-MVAC) + Avelumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m2 iv day 1 in combination (DD-MVAC). Each cycle is given every 2 weeks for a maximum of 4 administrations. Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks.

    Investigational medicinal product name
    Vinblastine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    vinblastine 3 mg/m2 i.v. day 2 in combination (DD-MVAC). Each cycle is given every 2 weeks for a maximum of 4 administrations. Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    cisplatin 70 mg/m2 iv day 2 in combination (DD-MVAC). Each cycle is given every 2 weeks for a maximum of 4 administrations. Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks.

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    doxorubicin 30 mg/m2 iv day 2 in combination (DD-MVAC). Each cycle is given every 2 weeks for a maximum of 4 administrations. Pegfilgrastim 6 mg subcutaneous (SQ) 24-48 hours after completion of Chemotherapy should be given. Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks.

    Investigational medicinal product name
    Avelumab
    Investigational medicinal product code
    Other name
    Bavencio 20mg/mL
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Avelumab will be administered at a dose of 10 milligram per kilogram (10 mg/kg) 1-hour intravenous (i.v.) infusion once every 2 weeks. Dose reductions are not allowed. In combination with Chemotherapy, Avelumab will be given before the Chemotherapy.

    Arm title
    		 Cisplatin - eligible: CG + A
    Arm description
    		 Cisplatin-eligible subjects: Cisplatin, Gemcitabine (CG) + Avelumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avelumab
    Investigational medicinal product code
    Other name
    Bavencio 20mg/mL
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Avelumab will be administered at a dose of 10 milligram per kilogram (10 mg/kg) 1-hour intravenous (i.v.) infusion once every 2 weeks. Dose reductions are not allowed. In combination with Chemotherapy, Avelumab will be given before the Chemotherapy.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg/m2 iv in day 1 and day 8 in combination (CG). Each cycle is given every 3 weeks for a maximum of 4 administrations. Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 70 mg/m2 iv in day 1 in combination (CG). Each cycle is given every 3 weeks for a maximum of 4 administrations. Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks.

    Arm title
    		 Cisplatin - ineligible: PG + A
    Arm description
    		 Cisplatin-ineligible subjects: Paclitaxel, Gemcitabine (PG) + Avelumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avelumab
    Investigational medicinal product code
    Other name
    Bavencio 20mg/mL
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Avelumab will be administered at a dose of 10 milligram per kilogram (10 mg/kg) 1-hour intravenous (i.v.) infusion once every 2 weeks. Dose reductions are not allowed. In combination with Chemotherapy, Avelumab will be given before the Chemotherapy.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg/m2 iv in day 1 and day 15 in combination (PG). Each cycle is given every 4 weeks for a maximum of 4 administrations (2 cycles). Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks for 4 administrations.

    Investigational medicinal product name
    paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 80 mg/m2 iv in day 1 and day 15 in combination (PG). Each cycle is repeated every 4 weeks for a maximum of 4 administrations (2 cycles). Chemotherapy is associated with Avelumab 10 mg/kg i.v. given every 2 weeks for 4 administrations.

    Arm title
    		 Cisplatin - ineligible: A
    Arm description
    		 Cisplatin-ineligible subjects: Avelumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avelumab
    Investigational medicinal product code
    Other name
    Bavencio 20mg/mL
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Avelumab will be administered at a dose of 10 milligram per kilogram (10 mg/kg) 1-hour intravenous (i.v.) infusion once every 2 weeks. Dose reductions are not allowed. Avelumab is not associated with any chemotherapy within this arm.

    Number of subjects in period 1
    		Cisplatin - eligible : DD-MVAC + A Cisplatin - eligible: CG + A Cisplatin - ineligible: PG + A Cisplatin - ineligible: A
    Started
    39
    40
    29
    29
    Completed
    38
    36
    28
    28
    Not completed
    1
    4
    1
    1
         Consent withdrawn by subject
    1
    2
    1
    -
         Physician decision
    -
    1
    -
    -
         Technical problems
    -
    1
    -
    -
         Not resectable at entry study (no treatment)
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cisplatin - eligible : DD-MVAC + A
    Reporting group description
    		 Cisplatin-eligible subjects: Dose dense methotrexate, vinblastine, doxorubicin, cisplatin (DD-MVAC) + Avelumab

    Reporting group title
    Cisplatin - eligible: CG + A
    Reporting group description
    		 Cisplatin-eligible subjects: Cisplatin, Gemcitabine (CG) + Avelumab

    Reporting group title
    Cisplatin - ineligible: PG + A
    Reporting group description
    		 Cisplatin-ineligible subjects: Paclitaxel, Gemcitabine (PG) + Avelumab

    Reporting group title
    Cisplatin - ineligible: A
    Reporting group description
    		 Cisplatin-ineligible subjects: Avelumab

    Reporting group values
    		 Cisplatin - eligible : DD-MVAC + A Cisplatin - eligible: CG + A Cisplatin - ineligible: PG + A Cisplatin - ineligible: A Total
    Number of subjects
    		 39 40 29 29 137
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 24 17 3 4 48
        From 65-84 years
    		 15 23 26 25 89
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 63 (47 to 77) 68 (41 to 81) 72 (41 to 80) 74 (49 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 9 11 2 3 25
        Male
    		 30 29 27 26 112
    ECOG PS
    Units: Subjects
        Zero
    		 36 32 15 11 94
        One
    		 3 8 14 18 43
    Clinical Tumour stage
    Units: Subjects
        T2 N0 M0
    		 20 20 12 12 64
        T2 N0 M: missing
    		 1 0 0 0 1
        T2 NX M0
    		 11 8 6 12 37
        T2 NX M:missing
    		 0 2 0 0 2
        T3/T4 N0 M0
    		 1 2 4 2 9
        T3/T4 NX M0
    		 0 2 2 1 5
        T2 N1 M0
    		 3 1 2 0 6
        T3/T4 N1 M0
    		 2 0 0 2 4
        T2 N2/3 M0
    		 1 4 3 0 8
        T3/T4 N2 M0
    		 0 1 0 0 1
    Histological type
    Units: Subjects
        Muscle-invasive urothelial carcinoma
    		 32 38 23 25 118
        Urothelial carcinoma with mixed histology
    		 7 2 6 4 19
    BMI at screening
    Units: cm/kg²
        median (full range (min-max))
    		 26.7 (19.2 to 50.2) 26.5 (18 to 36.8) 25.9 (17.9 to 36.5) 27.7 (22.3 to 34) -
    At screening: GFR
    Units: ml/min
        median (full range (min-max))
    		 85 (60 to 166) 89 (60 to 154) 67 (34 to 94) 64 (29 to 115) -

    End points

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    End points reporting groups
    Reporting group title
    Cisplatin - eligible : DD-MVAC + A
    Reporting group description
    		 Cisplatin-eligible subjects: Dose dense methotrexate, vinblastine, doxorubicin, cisplatin (DD-MVAC) + Avelumab

    Reporting group title
    Cisplatin - eligible: CG + A
    Reporting group description
    		 Cisplatin-eligible subjects: Cisplatin, Gemcitabine (CG) + Avelumab

    Reporting group title
    Cisplatin - ineligible: PG + A
    Reporting group description
    		 Cisplatin-ineligible subjects: Paclitaxel, Gemcitabine (PG) + Avelumab

    Reporting group title
    Cisplatin - ineligible: A
    Reporting group description
    		 Cisplatin-ineligible subjects: Avelumab

    Primary: pathological complete response

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    End point title
    		 pathological complete response
    End point description
    pathological complete response: ypT0/TisN0. The primary endpoint was pCR, defined as the absence of invasive residual disease (ypT0/Tis) and no microscopic lymph node involvement (ypN0) in the surgical specimen of evaluable patients. Patients who received at least one dose of each medication in their respective treatment arm and underwent cystectomy were considered evaluable. Patients experiencing early progression that precluded surgery were considered evaluable and assessed as therapeutic failures.
    End point type
    Primary
    End point timeframe
    at surgery
    End point values
    		 Cisplatin - eligible : DD-MVAC + A Cisplatin - eligible: CG + A Cisplatin - ineligible: PG + A Cisplatin - ineligible: A
    Number of subjects analysed
    38 [1]
    36 [2]
    28 [3]
    28 [4]
    Units: patients
    38
    36
    28
    28
    Notes
    [1] - evaluable patients
    [2] - evaluable patients
    [3] - evaluable patients
    [4] - evaluable patients
    Statistical analysis title
    		 pCR - Cisplatin eligible - ddMVAC-A
    Statistical analysis description
    In Cisplatin eligible cohort ddmvac Pathological response rates were estimated with 95%CIs using Wilson method. The null hypothesis should be rejected if the true pCR rate was >= 45%. A two-stage Simon design was applied for each treatment regimen.
    Comparison groups
    Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A v Cisplatin - eligible : DD-MVAC + A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 pathological complete response rate
    Point estimate
    58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42
         upper limit
    		 72
    Notes
    [5] - Single-arm phase II trial with hypothesis testing against a historical threshold
    Statistical analysis title
    		 pCR - Cisplatin eligible- GC-A
    Statistical analysis description
    Pathological response rates were estimated with 95%CIs using Wilson method. The null hypothesis should be rejected if the true pCR rate was >= 45%. A two-stage Simon design was applied for each treatment regimen. N = 36
    Comparison groups
    Cisplatin - eligible: CG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 pCR
    Point estimate
    53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 37
         upper limit
    		 68
    Notes
    [6] - Single-arm phase II trial with hypothesis testing against a historical threshold
    Statistical analysis title
    		 pCR Cisplatin-ineligible cohort - PG-A
    Statistical analysis description
    Pathological response rates were estimated with 95%CIs using Wilson method. The null hypothesis should be rejected if the true pCR rate was >= 45%. A two-stage Simon design was applied for each treatment regimen. N = 28
    Comparison groups
    Cisplatin - ineligible: PG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    Parameter type
    		 pathological complete response rate
    Point estimate
    14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 31
    Notes
    [7] - Single-arm phase II trial with hypothesis testing against a historical threshold
    Statistical analysis title
    		 pCR - Cisplatin-ineligible cohort- A
    Statistical analysis description
    Pathological response rates were estimated with 95%CIs using Wilson method. The null hypothesis should be rejected if the true pCR rate was >= 45%. A two-stage Simon design was applied for each treatment regimen. N=28
    Comparison groups
    Cisplatin - ineligible: A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 pathological complete response rate
    Point estimate
    32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18
         upper limit
    		 51
    Notes
    [8] - Single-arm phase II trial with hypothesis testing against a historical threshold
    Statistical analysis title
    		 Time-to-event : EFS 12 months GC-A
    Statistical analysis description
    the Kaplan- Meier method, with censoring for patients without predefined events or lost to follow- up at the data cut- off. 12 months EFS with 95%CI. N = 36
    Comparison groups
    Cisplatin - eligible: CG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 73
         upper limit
    		 97
    Notes
    [9] - Descriptive analysis for EFS at 12 months
    Statistical analysis title
    		 Time-to-event : EFS at 36 months GC-A
    Statistical analysis description
    Time to event analyses using kaplan meier estimate and the EFS at 36 months with a 95% CI. N = 36
    Comparison groups
    Cisplatin - eligible: CG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51
         upper limit
    		 82
    Notes
    [10] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : EFS 12 months ddMVAC-A
    Statistical analysis description
    Kaplan-Meier method, EFS at 12 months with 95CI. N = 38
    Comparison groups
    Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 84
         upper limit
    		 100
    Notes
    [11] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : EFS 36 months ddMVAC-A
    Statistical analysis description
    Kaplan-Meier Method N = 28
    Comparison groups
    Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 69
         upper limit
    		 95
    Notes
    [12] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : EFS at 12 months PG-A
    Statistical analysis description
    Kaplan meier method. N = 28
    Comparison groups
    Cisplatin - ineligible: PG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    60
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 44
         upper limit
    		 81
    Notes
    [13] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : EFS 36 months PG-A
    Statistical analysis description
    Kaplan-meier estimation and presentation with Event Free Survival at 12 month and 36 month with 95%CI. N = 28
    Comparison groups
    Cisplatin - ineligible: PG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26
         upper limit
    		 65
    Notes
    [14] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : EFS 12 months A
    Statistical analysis description
    Kaplan-meier estimation and presentation with Event Free Survival at 12 month and 36 month with 95%CI N = 28
    Comparison groups
    Cisplatin - ineligible: A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49
         upper limit
    		 85
    Notes
    [15] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : EFS 36 months A
    Statistical analysis description
    Kaplan-meier estimation and presentation with Event Free Survival at 12 month and 36 month with 95%CI N = 28
    Comparison groups
    Cisplatin - ineligible: A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    Method
    Parameter type
    		 EFS (%)
    Point estimate
    43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28
         upper limit
    		 66
    Notes
    [16] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : OS 12 months ddMVAC-A
    Statistical analysis description
    Kaplan-meier estimation and presentation with overall survival at 12 month and 36 month with 95%CI N = 38
    Comparison groups
    Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 88
         upper limit
    		 100
    Notes
    [17] - descriptive
    Statistical analysis title
    		 Time-to-event : OS 36 months ddMVAC-A
    Statistical analysis description
    Kaplan-meier estimation and presentation with overall Survival at 12 month and 36 month with 95%CI N= 38
    Comparison groups
    Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 76
         upper limit
    		 98
    Notes
    [18] - Descriptive
    Statistical analysis title
    		 Time-to-event : OS 12 months GC-A
    Statistical analysis description
    Kaplan-meier estimation and presentation with Overall Survival at 12 month and 36 month with 95%CI N = 36
    Comparison groups
    Cisplatin - eligible: CG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 84
         upper limit
    		 100
    Notes
    [19] - Descriptive
    Statistical analysis title
    		 Time-to-event : OS 36 months GC-A
    Statistical analysis description
    Kaplan-meier estimation and presentation with overall Survival at 12 month and 36 month with 95%CI N = 36
    Comparison groups
    Cisplatin - eligible: CG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - ineligible: PG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53
         upper limit
    		 84
    Notes
    [20] - Descriptive
    Statistical analysis title
    		 Time-to-event : OS 12 months PG-A
    Statistical analysis description
    Kaplan-meier estimation and presentation with overall Survival at 12 month and 36 month with 95%CI N=28
    Comparison groups
    Cisplatin - ineligible: PG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 68
         upper limit
    		 98
    Notes
    [21] - Descriptive
    Statistical analysis title
    		 Time-to-event : OS 36 months PG-A
    Statistical analysis description
    Kaplan-meier estimation and presentation with overall Survival at 12 month and 36 month with 95%CI N = 28
    Comparison groups
    Cisplatin - ineligible: PG + A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33
         upper limit
    		 71
    Notes
    [22] - Descriptive
    Statistical analysis title
    		 Time-to-event : OS 12 months A
    Statistical analysis description
    Kaplan-meier estimation and presentation with overall Survival at 12 month and 36 month with 95%CI N = 28
    Comparison groups
    Cisplatin - ineligible: A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 65
         upper limit
    		 95
    Notes
    [23] - Descriptive survival analyses
    Statistical analysis title
    		 Time-to-event : OS 36 months A
    Statistical analysis description
    Kaplan-meier estimation and presentation with overall Survival at 12 month and 36 month with 95%CI. N = 28
    Comparison groups
    Cisplatin - ineligible: A v Cisplatin - eligible : DD-MVAC + A v Cisplatin - eligible: CG + A v Cisplatin - ineligible: PG + A
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 other [24]
    Method
    Parameter type
    		 OS(%)
    Point estimate
    42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27
         upper limit
    		 65
    Notes
    [24] - Descriptive survival analyses

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Adverse event reporting additional description
    The adverse events are not reported in format that fits this platform. Please see attached documents for full analysis.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28
    Reporting groups
    Reporting group title
    Cisplatin-eligible cohort ddMVAC A
    Reporting group description
    		 Cisplatin-eligible cohort ddMVAC A N = 39

    Reporting group title
    Cisplatin-eligible cohort GC-A
    Reporting group description
    		 Cisplatin-eligible cohort GC-A

    Reporting group title
    Cisplatin-ineligible cohort PG-A
    Reporting group description
    		 -

    Reporting group title
    Cisplatin-ineligible cohort A
    Reporting group description
    		 Cisplatin-ineligible cohort A

    Serious adverse events
    		 Cisplatin-eligible cohort ddMVAC A Cisplatin-eligible cohort GC-A Cisplatin-ineligible cohort PG-A Cisplatin-ineligible cohort A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 39 (46.15%)
    19 / 40 (47.50%)
    10 / 28 (35.71%)
    6 / 28 (21.43%)
         number of deaths (all causes)
    6
    13
    16
    16
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Acute kidney injury
         subjects affected / exposed
    6 / 39 (15.38%)
    6 / 40 (15.00%)
    6 / 28 (21.43%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    2 / 6
    3 / 6
    0 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 40 (5.00%)
    0 / 28 (0.00%)
    3 / 28 (10.71%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 40 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Sepsis
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 40 (5.00%)
    0 / 28 (0.00%)
    3 / 28 (10.71%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 40 (5.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Pyelonephritis
         subjects affected / exposed
    5 / 39 (12.82%)
    3 / 40 (7.50%)
    5 / 28 (17.86%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 3
    1 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Cisplatin-eligible cohort ddMVAC A Cisplatin-eligible cohort GC-A Cisplatin-ineligible cohort PG-A Cisplatin-ineligible cohort A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 39 (100.00%)
    40 / 40 (100.00%)
    27 / 28 (96.43%)
    25 / 28 (89.29%)
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    11 / 39 (28.21%)
    24 / 40 (60.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
         occurrences all number
    11
    24
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    18 / 39 (46.15%)
    21 / 40 (52.50%)
    5 / 28 (17.86%)
    1 / 28 (3.57%)
         occurrences all number
    18
    21
    5
    1
    Constipation
         subjects affected / exposed
    18 / 39 (46.15%)
    15 / 40 (37.50%)
    6 / 28 (21.43%)
    2 / 28 (7.14%)
         occurrences all number
    18
    15
    6
    2
    Psychiatric disorders
    Asthenia
         subjects affected / exposed
    32 / 39 (82.05%)
    32 / 40 (80.00%)
    20 / 28 (71.43%)
    15 / 28 (53.57%)
         occurrences all number
    32
    32
    20
    15
    Anorexia
         subjects affected / exposed
    14 / 39 (35.90%)
    19 / 40 (47.50%)
    6 / 28 (21.43%)
    7 / 28 (25.00%)
         occurrences all number
    14
    19
    6
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2018
    Belgium : Halt accrual in the cisplatin ineligible cohort (following FR competent authority disapproval of the study)
    25 Jan 2019
    Belgium: *Request to restart accrual in the cisplatin ineligible cohort *New/Amended patient information sheet/informed consent (including addendum) *New/Amended study documents *New/Amended information related to IMP or IMPD *New/Amended IDMC charter
    12 Mar 2019
    Belgium: *New/Amended patient information sheet/informed consent (including addendum) *New/Amended study documents *New/Amended protocol *Addition of participating centre
    03 Jun 2019
    France: New/Amended Reference Safety Information
    26 Sep 2019
    Belgium: *New/Amended patient information sheet/informed consent (including addendum) *Addition of participating centre
    13 Nov 2019
    France: *Closure of an approved site *New/Amended Reference Safety Information *New/Amended patient information sheet/informed consent (including addendum) *New/Amended protocol *Change of Principal Investigator
    19 Nov 2019
    Belgium: *New/Amended patient information sheet/informed consent (including addendum) *New/Amended study documents *New/Amended protocol *New/Amended Reference Safety Information
    16 Jun 2020
    France: *New/Amended patient information sheet/informed consent (including addendum) *New/Amended protocol *New/Amended other study documents *New/Amended Reference Safety Information
    28 Jul 2020
    Belgium: *New/Amended patient information sheet/informed consent (including addendum) *New/Amended protocol *New/Amended Reference Safety Information
    30 Mar 2021
    France: New/Amended Reference Safety Information
    06 Apr 2021
    Belgium: New/Amended Reference Safety Information
    29 Nov 2021
    Belgium: Addition of participating centre
    17 Mar 2023
    Belgium: *Change of national coordinator *Change in trial logistic (not site related) *New/Amended protocol
    24 Mar 2023
    France: *New/Amended protocol *New/Amended patient information sheet/informed consent (including addendum)

    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.
    There were no limitations and caveats.
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