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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1+ Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy

    Summary
    EudraCT number
    		 2018-000824-32
    Trial protocol
    		 GB   DK  
    Global end of trial date
    20 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2020
    First version publication date
    03 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V943A-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03520959
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IMDZ-04-1702: Immune Design Corp. Protocol Number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    20 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    0
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was terminated early by the Sponsor.

    Pre-assignment
    Screening details
    		 Participants with synovial sarcoma expressing New York esophageal squamous cell carcinoma-1 (NY-ESO-1) were recruited in the United States.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Arm title
    		 CMB305
    Arm description
    		 A sequential regimen of LV305 and G305.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LV305
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered via subcutaneous (SC) injection.

    Investigational medicinal product name
    G305
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Administered via intramuscular (IM) injection.

    Number of subjects in period 1
    		CMB305
    Started
    1
    Completed
    0
    Not completed
    1
         Study terminated by Sponsor
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CMB305
    Reporting group description
    		 A sequential regimen of LV305 and G305.

    Reporting group values
    		 CMB305 Total
    Number of subjects
    		 1 1
    Age Categorical
    Units:
        Between 18 and 65 years
    		 1 1
    Sex: Female, Male
    Data are not reported due to the risk of identification of a person.
    Units:
        Subjects
    		 1 1
    Ethnicity
    Data are not reported due to the risk of identification of a person.
    Units: Subjects
        Subjects
    		 1 1
    Race
    Data are not reported due to the risk of identification of a person.
    Units: Subjects
        Subjects
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    CMB305
    Reporting group description
    		 A sequential regimen of LV305 and G305.

    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 investigator-determined date of disease progression or death, whichever comes first, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Primary
    End point timeframe
    From randomization to investigator-determined date of disease progression or death, assessed up to 24 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: The study terminated prior to data collection and analysis.
    End point values
    		 CMB305
    Number of subjects analysed
    0 [2]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [2] - The study terminated early and no endpoint data were analyzed.
    No statistical analyses for this end point

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS) [3]
    End point description
    OS is defined as the time from randomization to the date of death. No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Primary
    End point timeframe
    From randomization to date of death, assessed up to 66 months.
    Notes
    [3] - 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: The study terminated prior to data collection and analysis.
    End point values
    		 CMB305
    Number of subjects analysed
    0 [4]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [4] - The study terminated early and no endpoint data were analyzed.
    No statistical analyses for this end point

    Secondary: Time to Next Treatment (TTNT)

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    End point title
    		 Time to Next Treatment (TTNT)
    End point description
    TTNT is defined as the time from randomization to the start of post-study treatment subsequent intervention: [TTNT = start date of subsequent intervention – randomization date + 1]. Subsequent intervention includes anticancer therapy, cancer-related surgery and local regional therapy. Participants who do not start any post-study treatment intervention will be censored at their last known date of being alive. No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.
    End point values
    		 CMB305
    Number of subjects analysed
    0 [5]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [5] - The study terminated early and no endpoint data were analyzed.
    No statistical analyses for this end point

    Secondary: Distant Metastasis Free Survival (DMFS)

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    End point title
    		 Distant Metastasis Free Survival (DMFS)
    End point description
    DMFS is defined as the time from randomization to evidence of a new distant metastasis not documented at time of randomization: [DMFS = a new distant metastasis documented date – randomization date + 1]. Participants who do not have any new distant metastasis will be censored at their last tumor assessment. No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.
    End point values
    		 CMB305
    Number of subjects analysed
    0 [6]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [6] - The study terminated early and no endpoint data were analyzed.
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR)
    End point description
    ORR defined by RECIST v1.1 will be summarized by the number and percent of subjects who achieve a complete response (CR) or partial response (PR) based on the investigator’s assessment. ORR will be compared between treatment arms using a logistic regression. No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    From randomization to investigator-determined date of disease progression, assessed up to 24 months.
    End point values
    		 CMB305
    Number of subjects analysed
    0 [7]
    Units: Percentage of participants
        number (confidence interval 95%)
    ( to )
    Notes
    [7] - The study terminated early and no endpoint data were analyzed.
    No statistical analyses for this end point

    Secondary: Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)

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    End point title
    		 Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)
    End point description
    Safety will be assessed primarily based on reported adverse events (AEs), medical events of interest (MEOIs), laboratory values, and concomitant medications reported from initiation of treatment with CMB305 or placebo. No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.
    End point values
    		 CMB305
    Number of subjects analysed
    1 [8]
    Units: Participants
    1
    Notes
    [8] - The study terminated early and no endpoint data were analyzed.
    No statistical analyses for this end point

    Secondary: Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires

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    End point title
    		 Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires
    End point description
    QoL evaluated using the EQ-5D-5L (participants ≥18 years of age) or the EQ-5D-Y (participants 12 to <18 years of age). EQ-5D-5L descriptive system is comprised of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group. In the EQ-VAS, participants recorded their health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to 12 months
    End point values
    		 CMB305
    Number of subjects analysed
    0 [9]
    Units: Score on a scale
    Notes
    [9] - The study terminated early and no endpoint data were analyzed.
    No statistical analyses for this end point

    Secondary: Number of Participants Who Discontinued Study Treatment Due to an AE

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    End point title
    		 Number of Participants Who Discontinued Study Treatment Due to an AE
    End point description
    The number of all participants who discontinued study treatment due to an AE is presented. No data were collected or analyzed for this outcome measure due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    Up to approximately 2 months
    End point values
    		 CMB305
    Number of subjects analysed
    0 [10]
    Units: Participants
    Notes
    [10] - The study terminated early and no endpoint data were analyzed.
    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 2 months
    Adverse event reporting additional description
    0 participants are reported due to the risk of identification of a person.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    n/a
    Reporting groups
    Reporting group title
    CMB305
    Reporting group description
    		 Sequentially administered LV305 and G305.

    Serious adverse events
    		 CMB305
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 CMB305
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    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: The study terminated prior to data collection and analysis.

    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.
    Study was stopped early due to Sponsor decision.
    For support, Contact us.
    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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