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    Clinical Trial Results:
    A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination with Daratumumab, Compared with Daratumumab Alone in Subjects with Relapsed or Refractory Multiple Myeloma

    Summary
    EudraCT number
    2017-002611-34
    Trial protocol
    BE   ES   FR   GR  
    Global end of trial date
    19 Nov 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    54767414MMY2036
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03357952
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Highway 202, Raritan, NJ, United States, 08869-1420
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    16 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to assess the safety of the combination of JNJ-63723283 and daratumumab and to compare the overall response rate (ORR) in subjects treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Israel: 5
    Worldwide total number of subjects
    10
    EEA total number of subjects
    5
    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)
    6
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 10 subjects were enrolled in the study. Among these, 9 subjects were included in the Safety Run-in phase (Part 1) who received daratumumab intravenous (IV) and JNJ-63723283 IV and 1 subject randomised to Arm A in Part 2 of the study who received daratumumab IV alone.

    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
    Part 1: Daratumumab + JNJ-63723283
    Arm description
    Subjects in safety run-in cohort received daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 milligram (mg) IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Subjects continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
    Arm type
    Active comparator

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards).

    Investigational medicinal product name
    JNJ-63723283
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days.

    Arm title
    Part 2: Daratumumab (Arm A)
    Arm description
    Subjects in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All subjects were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
    Arm type
    Active comparator

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion, Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards).

    Number of subjects in period 1
    Part 1: Daratumumab + JNJ-63723283 Part 2: Daratumumab (Arm A)
    Started
    9
    1
    Completed
    0
    0
    Not completed
    9
    1
         Sponsor Decision
    9
    -
         Withdrawal by Subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: Daratumumab + JNJ-63723283
    Reporting group description
    Subjects in safety run-in cohort received daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 milligram (mg) IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Subjects continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.

    Reporting group title
    Part 2: Daratumumab (Arm A)
    Reporting group description
    Subjects in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All subjects were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.

    Reporting group values
    Part 1: Daratumumab + JNJ-63723283 Part 2: Daratumumab (Arm A) Total
    Number of subjects
    9 1 10
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    5 1 6
        From 65 to 84 years
    4 0 4
        85 years and over
    0 0 0
    Title for AgeContinuous
    Here, '99999' indicated standard deviation could not be calculated for 1 subject.
    Units: years
        arithmetic mean (standard deviation)
    63 ± 10.97 43 ± 99999 -
    Title for Gender
    Units: subjects
        Female
    4 0 4
        Male
    5 1 6

    End points

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    End points reporting groups
    Reporting group title
    Part 1: Daratumumab + JNJ-63723283
    Reporting group description
    Subjects in safety run-in cohort received daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 milligram (mg) IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Subjects continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.

    Reporting group title
    Part 2: Daratumumab (Arm A)
    Reporting group description
    Subjects in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All subjects were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.

    Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAE) in Safety run-in Phase (Part 1)

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAE) in Safety run-in Phase (Part 1) [1] [2]
    End point description
    An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events (AEs) which will occur up to 2 years that were absent before treatment or that worsened relative to pre-treatment state. Safety analysis set included all subjects who received at least 1 dose of study agent (JNJ-63723283 or daratumumab, partial or complete) in safety run-in phase of the study.
    End point type
    Primary
    End point timeframe
    Up to 2 years
    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: Descriptive statistics was done, no inferential statistical analysis was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Part 1: Daratumumab + JNJ-63723283
    Number of subjects analysed
    9
    Units: Subjects
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With Dose Limiting Toxicity in Safety run-in Phase (Part 1)

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    End point title
    Number of Subjects With Dose Limiting Toxicity in Safety run-in Phase (Part 1) [3] [4]
    End point description
    Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the subjects during observation of 28 days (Part 1) of treatment Cycle 1. Safety analysis set included all subjects who received at least 1 dose of study agent (JNJ-63723283 or daratumumab, partial or complete) in safety run-in phase.
    End point type
    Primary
    End point timeframe
    Cycle 1 (28 days)
    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: Descriptive statistics was done, no inferential statistical analysis was performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Part 1: Daratumumab + JNJ-63723283
    Number of subjects analysed
    9
    Units: Subjects
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAE) in Part 2

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAE) in Part 2 [5]
    End point description
    An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events (AEs) which will occur up to 2 years that were absent before treatment or that worsened relative to pre-treatment state. Safety analysis set included all subjects who received at least 1 dose of study agent in Part 2 of the study.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Part 2: Daratumumab (Arm A)
    Number of subjects analysed
    1
    Units: Subjects
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 2 years
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Part 1: Daratumumab + JNJ-63723283
    Reporting group description
    Subjects in safety run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 milligram (mg) IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Subjects continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.

    Reporting group title
    Part 2: Daratumumab (Arm A)
    Reporting group description
    Subjects in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All subjects were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.

    Serious adverse events
    Part 1: Daratumumab + JNJ-63723283 Part 2: Daratumumab (Arm A)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Encephalitis Autoimmune
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile Neutropenia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic Shock
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Part 1: Daratumumab + JNJ-63723283 Part 2: Daratumumab (Arm A)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    1 / 1 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Chills
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Oedema Peripheral
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Influenza Like Illness
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    Pyrexia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    Dysphonia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Rhinitis Allergic
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Throat Irritation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Lipase Increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    Weight Decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Dizziness
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Leukopenia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Lymphopenia
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 1 (0.00%)
         occurrences all number
    12
    0
    Neutropenia
         subjects affected / exposed
    4 / 9 (44.44%)
    0 / 1 (0.00%)
         occurrences all number
    13
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 1 (100.00%)
         occurrences all number
    18
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Corneal Degeneration
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    Dyspepsia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Dry Mouth
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    3 / 9 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Muscle Spasms
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Muscle Atrophy
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Myopathy
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Osteomyelitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    7
    0
    Herpes Simplex
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Body Tinea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal Candidiasis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperamylasaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Folate Deficiency
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Dehydration
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2017
    Revised DLT criteria • Revised eligibility criterion for recovery from toxicity from previous immunotherapy treatment • Added a criterion for dose delay due to non-immune-related adverse events (AEs). • The split first dose of daratumumab was replaced with the full daratumumab 16 milligrams per kilogram (mg/kg) regimen. • Clarified that communication with health authorities will occur before proceeding to Part 3. • Added a new section regarding study termination for safety considerations.
    20 Jun 2018
    On 25 May 2018, the sponsor stopped further enrollment into this study, Study 54767414MMY2036, based on safety and efficacy findings in the Study 54767414LUC2001, which combined daratumumab with atezolizumab in non-small cell lung cancer. At the third planned DMC review on 23 May 2018, the DMC reviewed the subject data for the Study 54767414LUC2001. The data monitoring committee (DMC) determined that there was no observed benefit in combination treatment arm (daratumumab+atezolizumab) over atezolizumab alone and recommended stopping enrollment of the study. In addition, the DMC recommended discontinuation of daratumumab treatment to all subjects receiving combination therapy (subjects randomized to the combination Arm B, and subjects randomized to Arm A who had crossed over into Arm B). Although no unexpected imbalances in on-treatment toxicities were observed, the DMC noted a clear early difference in number of deaths between atezolizumab monotherapy arm and combination arm. Discrepancy was observed within first 3 months of start of treatment, where the number of deaths were 4 in the atezolizumab arm and 10 in the combination arm, giving rise to 3-month survival rates of 90.7 percent (%) for the atezolizumab arm and 76.2% for the combination arm. Since the benefit/risk ratio changed for combination therapy in Study 54767414LUC2001, sponsor decided to suspend enrollment into other studies that combine daratumumab and a programmed death-1 (PD-1) or programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) regardless of indication. In addition to discontinuing enrollment in this study, treatment with the combination of daratumumab and JNJ-63723283 was discontinued and ongoing subjects were given the option to continue on daratumumab monotherapy until subject met one or more of the treatment discontinuation criteria. Assessments and data collection for the new daratumumab monotherapy period were defined and a window for End-of-Treatment (EOT) visit was added.
    28 Apr 2020
    The overall reason for the amendment was to provide flexibility for study investigators to prioritize the safety of their subjects during the global coronavirus (COVID-19) pandemic. To ensure continuity of study treatment, while limiting subjects’ time spent at the study center, for subjects who will continue to receive daratumumab intravenous (IV), the duration of infusion may be shortened starting in Cycle 2 onwards to a 90-minute infusion for subjects without a history of an infusion related reaction after the third dose, at the discretion of the investigator. Detailed information regarding daratumumab IV administration, including infusion rates and duration, is removed and will be provided only in the Site Investigational Product Procedures Manual (SIPPM)’.

    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.
    1 subject enrolled in Part 2 was not evaluable for efficacy, pharmacokinetics (pk) and immunogenicity endpoints. Hence, these endpoints were not collected. Sponsor suspended enrollment in Part 2 and stopped it early. Part 3 was not conducted.
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