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    Clinical Trial Results:
    A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of MOXR0916 in Combination with Atezolizumab versus Atezolizumab Alone in Patients with Untreated Locally Advanced or Metastatic Urothelial Carcinoma who are Ineligible for Cisplatin-Based Therapy

    Summary
    EudraCT number
    		 2016-004165-58
    Trial protocol
    		 GB   BE   PT   FR  
    Global end of trial date
    25 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2019
    First version publication date
    10 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GO39590
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03029832
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    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
    25 Apr 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    A Study of MOXR0916 in Combination with Atezolizumab versus Atezolizumab Alone in Subjects with Untreated Locally Advanced or Metastatic Urothelial Carcinoma who are Ineligible for Cisplatin-Based Therapy
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Apr 2017
    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
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    5
    EEA total number of subjects
    2
    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)
    1
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Only 5 subjects were recruited due to slow patient accrual and discontinuation of clinical development of MOXR0916.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MOXR0916 plus Atezolizumab
    Arm description
    		 Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MOXR0916
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Arm title
    		 Atezolizumab
    Arm description
    		 Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Number of subjects in period 1
    		MOXR0916 plus Atezolizumab Atezolizumab
    Started
    4
    1
    Completed
    0
    0
    Not completed
    4
    1
         Study Terminated By Sponsor
    1
    1
         Safety Follow-Up Completed
    2
    -
         Adverse event, serious fatal (disease progression)
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MOXR0916 plus Atezolizumab
    Reporting group description
    		 Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Reporting group values
    		 MOXR0916 plus Atezolizumab Atezolizumab Total
    Number of subjects
    		 4 1 5
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1 0 1
        From 65-84 years
    		 3 1 4
        85 years and over
    		 0 0 0
    Age Continuous
    99= arbitrary value to protect subject confidentiality; 9999 = non-estimable value
    Units: years
        arithmetic mean (standard deviation)
    		 71.0 ± 10.6 99 ± 9999 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 2 0 2
        Male
    		 2 1 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 4 1 5
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    MOXR0916 plus Atezolizumab
    Reporting group description
    		 Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Primary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS) [1]
    End point description
    PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of >= 5 millimeter (mm) in the sum of diameters.
    End point type
    Primary
    End point timeframe
    Up to approximately 45 months
    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: Due to the termination of the study and small number of subjects, no analyses were performed.
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [2] - Due to early termination, no formal analyses were performed for PFS and 0 subjects analyzed.
    [3] - Due to early termination, no formal analyses were performed for PFS and 0 subjects analyzed.
    No statistical analyses for this end point

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS) [4]
    End point description
    Kaplan Meier estimate of median OS was defined as the time at which half of the subjects had died, regardless of the cause of death.
    End point type
    Primary
    End point timeframe
    Up to approximately 45 months
    Notes
    [4] - 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: Due to the termination of the study and small number of subjects, no analyses were performed.
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [5] - Due to early termination, no formal analyses were performed for OS and 0 subjects analyzed.
    [6] - Due to early termination, no formal analyses were performed for OS and 0 subjects analyzed.
    No statistical analyses for this end point

    Secondary: Objective Response (OR) According to RECIST v1.1

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    End point title
    		 Objective Response (OR) According to RECIST v1.1
    End point description
    OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
    End point type
    Secondary
    End point timeframe
    Up to approximately 45 months
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [7] - Due to early termination, no formal analyses were performed for OR and 0 subjects analyzed.
    [8] - Due to early termination, no formal analyses were performed for OR and 0 subjects analyzed.
    No statistical analyses for this end point

    Secondary: Duration of Objective Response (DOR) According to RECIST v1.1

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    End point title
    		 Duration of Objective Response (DOR) According to RECIST v1.1
    End point description
    DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
    End point type
    Secondary
    End point timeframe
    Up to approximately 45 months
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [9] - Due to early termination, no formal analyses were performed for DOR and 0 subjects analyzed.
    [10] - Due to early termination, no formal analyses were performed for DOR and 0 subjects analyzed.
    No statistical analyses for this end point

    Secondary: Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Subject-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)

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    End point title
    		 Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Subject-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)
    End point description
    The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a subject’s life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the subject’s activities and 10 indicating that the symptom is “as bad as you can imagine” or “interfered completely” with the subject’s life.
    End point type
    Secondary
    End point timeframe
    Up to approximately 45 months
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: score
    Notes
    [11] - Due to early termination, no formal analyses performed for this endpoint.
    [12] - Due to early termination, no formal analyses performed for this endpoint.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Symptom Interference with Daily Living at the Time of Progression According to the MDASI

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    End point title
    		 Percentage of Subjects Reporting Symptom Interference with Daily Living at the Time of Progression According to the MDASI
    End point description
    The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant’s life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant’s activities and 10 indicating that the symptom is “as bad as you can imagine” or “interfered completely” with the participant’s life.
    End point type
    Secondary
    End point timeframe
    Up to approximately 45 months
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [13]
    0 [14]
    Units: percentage of subjects
    Notes
    [13] - Due to early termination, no formal analyses were performed for this endpoint.
    [14] - Due to early termination, no formal analyses were performed for this endpoint.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Adverse Event (AEs)

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    End point title
    		 Percentage of Subjects With Adverse Event (AEs)
    End point description
    An adverse event is any untoward medical occurrence, regardless of causal attribution.
    End point type
    Secondary
    End point timeframe
    Up to approximately 45 months
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [15]
    0 [16]
    Units: subjects
    Notes
    [15] - Data were collected but are not summarized due to privacy concerns.
    [16] - Data were collected but are not summarized due to privacy concerns.
    No statistical analyses for this end point

    Secondary: Area under the plasma drug concentration-time curve (AUC) of MOXR0916 and Atezolizumab

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    End point title
    		 Area under the plasma drug concentration-time curve (AUC) of MOXR0916 and Atezolizumab
    End point description
    AUC represents the body's exposure to an administered drug.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [17]
    0 [18]
    Units: ng*day/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [17] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    [18] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab

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    End point title
    		 Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab
    End point description
    Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [19]
    0 [20]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [19] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    [20] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    No statistical analyses for this end point

    Secondary: Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab

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    End point title
    		 Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab
    End point description
    Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [21]
    0 [22]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [21] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    [22] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    No statistical analyses for this end point

    Secondary: Clearance of MOXR0916 and Atezolizumab

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    End point title
    		 Clearance of MOXR0916 and Atezolizumab
    End point description
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
    End point type
    Secondary
    End point timeframe
    Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [23]
    0 [24]
    Units: Cl/F
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [23] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    [24] - Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Anti-Therapeutic antibodies (ATAs) to MOXR0916 and Atezolizumab

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    End point title
    		 Percentage of Subjects with Anti-Therapeutic antibodies (ATAs) to MOXR0916 and Atezolizumab
    End point description
    ATAs may be produced by the body in response to an administered drug.
    End point type
    Secondary
    End point timeframe
    Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose
    End point values
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Number of subjects analysed
    0 [25]
    0 [26]
    Units: percentage of subjects
    Notes
    [25] - Due to early termination, no formal analyses were performed for this endpoint.
    [26] - Due to early termination, no formal analyses were performed for this endpoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to approximately 45 months
    Adverse event reporting additional description
    The safety population is defined as all patients who received at least one dose of the study medication. Data were collected for the adverse events but are not being summarized due to privacy concerns with low number of patients analyzed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    MOXR0916 plus Atezolizumab
    Reporting group description
    		 Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Reporting group title
    Atezolizumab
    Reporting group description
    		 Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

    Serious adverse events
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MOXR0916 plus Atezolizumab Atezolizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Data were collected for the adverse events but are not being summarized due to privacy concerns with low number of patients analyzed.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Dec 2016
    Addressed comments that were received from the United States (U.S.) Food and Drug Administration (FDA) during the review of the Investigational New Drug (IND) application.
    29 Sep 2017
    Protocol GO39590 has been amended to reflect the Sponsor’s decision to halt accrual due to enrollment challenges in the context of overall clinical development considerations for MOXR0916. As only 5 patients were enrolled, this trial will not meet its scientific objectives. Hence, study procedures that are not required for safety management or assessment of clinical benefit was streamlined or modified.

    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
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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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