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    Clinical Trial Results:
    CD20-Immunotargeting in Stage IV Melanoma Patients - A Prospective, Open Label, Two-Period Pilot Study to Evaluate Overall Tumor Responsive Rate

    Summary
    EudraCT number
    		 2010-023277-19
    Trial protocol
    		 AT  
    Global end of trial date
    28 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jul 2016
    First version publication date
    24 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CD20 Immunotargeting of Melanoma
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01376713
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria,
    Public contact
    UD Dr. Stephan Wagner, Medical University of Vienna, Department of Dermatology , 0043 14040077050, stephan.wagner@meduniwien.ac.at
    Scientific contact
    UD Dr. Stephan Wagner, Medical University of Vienna, Department of Dermatology , 0043 14040077050, stephan.wagner@meduniwien.ac.at
    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
    01 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the overall disease control rate according to criteria of RECIST v. 1.1
    Protection of trial subjects
    Exclusion of: Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) • Other past or current malignancy. • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment • History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae • HIV positive • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to enrolement, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities. • Significant concurrent, uncontrolled medical condition • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. • Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result • Screening laboratory values: hemoglobin < 8g/dL platelets <70 x 109/L leukocytes <1.5 x 109/L creatinine >2.0 times upper normal limit total bilirubin >1.5 times uppertotal bilirubin >1.5 times upper normal limit ALT >2.5 times upper normal limit alkaline phosphatase >2.5 times upper normal limit • Pregnant or lactating women. Efficacy, safety and laboratory assessments on a regular basis: MRI/CT, physical examination, ECOG, weight, 12-lead ECG, adverse events and concomitant therapy evaluation, hematology (hemoglobin, hematocrit, RBC, WBC + differentials), chemistry (ASAT, ALAT, alkaline phosphatase, total bilirubin, creatinine), serum pregnancy testing;
    Background therapy
    		 In this study, all concomitant medications were allowed, with the exception of: • treatment with any known marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer; • currently participating in any other interventional trials;
    Evidence for comparator
    		 not applicable
    Actual start date of recruitment
    21 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    5
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the population that is routinely treated for melanoma at the study sites.

    Pre-assignment
    Screening details
    		 Screening procedures for the study were performed from day -28 until day 0 before administration of study medication. Screening assessments were performed only after the patient has signed the informed consent form. Inclusion and exclusion criteria were checked accordingly at the screening visit.

    Period 1
    Period 1 title
    Arm A (Monotherapy) - Stage 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Arm title
    		 Arm A - Stage 1
    Arm description
    		 Initially, 10 eligible patients will be treated with ofatumumab (1000 mg) alone. Tumor imaging is planned at wk 4 (screening for rapid disease progression), 8, 16 and 24. Follow-up starts at wk 24. If interim analysis shows that at least 1 confirmed overall response (CR, PR) occurs, the study will proceed to Arm A stage 2. If ofatumumab at the 1000 mg dose is well tolerated, patients with disease progression will have the opportunity to receive at least 3 cycles of ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg DTIC (Arm A - Rescue Arm)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Arzerra
    Investigational medicinal product code
    Ofatumumab
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab will be administered at a dose of 1000mg iv weekly (+/- 2 days) for 8 weeks and q4w (+/- 1 week) for another 16 weeks.

    Number of subjects in period 1
    		Arm A - Stage 1
    Started
    10
    confirmed overall response, CR/PR
    0 [1]
    Completed
    8
    Not completed
    2
         Adverse event, serious fatal
    1
         death after disease progression
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Sequential study design - no patient enroled. For saving the xml-file, a number has to be entered. The information of no enrolment is given under non-completion reason.
    Period 2
    Period 2 title
    Arm A - Stage 1 - Rescue Arm
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Arm title
    		 Arm A - Stage 1 Rescue Arm
    Arm description
    		 If ofatumumab at the 1000 mg dose is well tolerated, patients with disease progression will have the opportunity to receive at least 3 cycles of ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg DTIC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Arzerra
    Investigational medicinal product code
    Ofatumumab
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients with disease progression received at least three cycles of Ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg Dacarbazine.

    Investigational medicinal product name
    Dacarbazine medac
    Investigational medicinal product code
    Dacarbazine
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients with disease progression received at least three cycles of Ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg Dacarbazine.

    Number of subjects in period 2
    		Arm A - Stage 1 Rescue Arm
    Started
    8
    Completed
    7
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A (Monotherapy) - Stage 1
    Reporting group description
    		 Initially, 10 eligible patients shall be treated with ofatumumab (1000 mg) alone. Tumor imaging was planned at wk 4 (screening for rapid disease progression), 8, 16 and 24. Follow-up started at wk 24. If interim analysis shows that at least 1 confirmed overall response oc-curs, the study should proceed to Arm A stage 2. If ofatumumab at the 1000 mg dose is well tolerated, patients with disease progression should have the opportunity to receive at least 3 cycles of ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg DTIC.

    Reporting group values
    		 Arm A (Monotherapy) - Stage 1 Total
    Number of subjects
    		 10 10
    Age categorical
    Patients have to be older than 18 years
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Arm A - Stage 1
    Reporting group description
    		 Initially, 10 eligible patients will be treated with ofatumumab (1000 mg) alone. Tumor imaging is planned at wk 4 (screening for rapid disease progression), 8, 16 and 24. Follow-up starts at wk 24. If interim analysis shows that at least 1 confirmed overall response (CR, PR) occurs, the study will proceed to Arm A stage 2. If ofatumumab at the 1000 mg dose is well tolerated, patients with disease progression will have the opportunity to receive at least 3 cycles of ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg DTIC (Arm A - Rescue Arm)
    Reporting group title
    Arm A - Stage 1 Rescue Arm
    Reporting group description
    		 If ofatumumab at the 1000 mg dose is well tolerated, patients with disease progression will have the opportunity to receive at least 3 cycles of ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg DTIC.

    Primary: Evaluation of overall disease control rate according to criteria of RECIST v. 1.1 (measurable disease))

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    End point title
    		 Evaluation of overall disease control rate according to criteria of RECIST v. 1.1 (measurable disease)) [1]
    End point description
    Efficacy criterion. The primary objective of this study is to evaluate the overall disease control rate according to criteria of RECIST v. 1.1. The primary endpoint disease control, is tested with Simon Two Stage Designs. The primary analysis is based on the full analysis set comprising all patients that received at least one dose of the study drug. Patients for which the primary endpoint is not available will be considered as treatment failures in this analysis. The one sided type I error rate for each of the hypothesis tests (H0A , H0B ) is set to 0.05.
    End point type
    Primary
    End point timeframe
    Disease control according to RECIST v. 1.1 criteria until week 24 (measurable disease).
    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: no further statistical sub-analysis
    End point values
    		 Arm A - Stage 1 Arm A - Stage 1 Rescue Arm
    Number of subjects analysed
    10 [2]
    6 [3]
    Units: Extent of response or disease
        Disease control rate (CR, PR, SD)
    6
    4
        Progressive Disease (PD)
    4
    2
    Notes
    [2] - please see data below, subject analysis sets
    [3] - 1 patient not analyzable
    No statistical analyses for this end point

    Primary: Evaluation of overall disease control rate according to ir-RC (overall response)

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    End point title
    		 Evaluation of overall disease control rate according to ir-RC (overall response) [4]
    End point description
    The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Evaluation by immune-related response criteria (ir-RC). This method of evaluation of the overall response is referred to in the Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria (Clin Cancer Res 2009;15(26) December 1, 2009. The ir-RC evaluation was not implemented in the clinical study protocol issued in 2010.
    End point type
    Primary
    End point timeframe
    Disease control according to immune-related response criteria until week 24 (overall response).
    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: no further statistical sub-analysis
    End point values
    		 Arm A - Stage 1 Arm A - Stage 1 Rescue Arm
    Number of subjects analysed
    10 [5]
    8
    Units: Extent of response or disease
        Disease control rate (CR, PR, SD)
    2
    1
        Progressive disease (PD)
    8
    7
    Notes
    [5] - SD in 2 patients
    No statistical analyses for this end point

    Primary: Evaluation of overall disease control rate according to criteria of RECIST v. 1.1 (overall response)

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    End point title
    		 Evaluation of overall disease control rate according to criteria of RECIST v. 1.1 (overall response) [6]
    End point description
    End point type
    Primary
    End point timeframe
    Disease control according to RECIST v. 1.1 criteria until week 24 (overall response).
    Notes
    [6] - 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: no further statistical sub-analysis
    End point values
    		 Arm A - Stage 1 Arm A - Stage 1 Rescue Arm
    Number of subjects analysed
    10 [7]
    8 [8]
    Units: Extent of response or disease
        Disease Control Rate (CR, PR, SD)
    1
    1
        Progressive disease (PD)
    9
    7
    Notes
    [7] - SD in 1 patient
    [8] - SD in 1 patient
    No statistical analyses for this end point

    Secondary: Assessment of progression-free survival (PFS) - RECIST v1.1 (overall response)

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    End point title
    		 Assessment of progression-free survival (PFS) - RECIST v1.1 (overall response)
    End point description
    End point type
    Secondary
    End point timeframe
    First day of treatment until first documentation of disease progression or death, whichever occurs first.
    End point values
    		 Arm A - Stage 1 Arm A - Stage 1 Rescue Arm
    Number of subjects analysed
    1 [9]
    1 [10]
    Units: Surrogate Endpoint
        Months
    5
    5
    Notes
    [9] - for patients with disease control only
    [10] - for patients with disease control only
    No statistical analyses for this end point

    Secondary: Overall survival (OS) - RECIST v1.1 (overall response)

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    End point title
    		 Overall survival (OS) - RECIST v1.1 (overall response)
    End point description
    End point type
    Secondary
    End point timeframe
    Every three months (+/- 1 month) until all patients have died or are lost to follow up.
    End point values
    		 Arm A - Stage 1 Arm A - Stage 1 Rescue Arm
    Number of subjects analysed
    10 [11]
    8 [12]
    Units: Surrogate endpoint
    11
    11
    Notes
    [11] - given as mean value in months
    [12] - given as mean value in months
    No statistical analyses for this end point

    Secondary: Assessment of progression-free survival (PFS) - ir-RC (overall response)

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    End point title
    		 Assessment of progression-free survival (PFS) - ir-RC (overall response)
    End point description
    Efficacy endpoint
    End point type
    Secondary
    End point timeframe
    First day of treatment until first documentation of disease progression or death, whichever occurs first.
    End point values
    		 Arm A - Stage 1 Arm A - Stage 1 Rescue Arm
    Number of subjects analysed
    10
    8
    Units: months
        months
    22
    22
    No statistical analyses for this end point

    Secondary: Overall survival (OS) - ir-RC (overall response)

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    End point title
    		 Overall survival (OS) - ir-RC (overall response)
    End point description
    End point type
    Secondary
    End point timeframe
    Every three months (+/- 1 month) until all patients have died or are lost to follow up.
    End point values
    		 Arm A - Stage 1 Arm A - Stage 1 Rescue Arm
    Number of subjects analysed
    10
    8
    Units: months
        months
    22
    22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Induction (week 1-8 qw) until Follow-up visit (3 months post treatment)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Arm A (Monotherapy) - Stage 1
    Reporting group description
    		 Stage 1: Treatment with Ofatumumab (1000 mg) only. Tumor imaging is planned at wk 4 (screening for rapid disease progression), 8, 16 and 24. Follow-up starts at wk 24. If interim analysis shows that at least 1 confirmed overall response occurs, the study will proceed to Arm A stage 2. If ofatumumab at the 1000 mg dose is well tolerated, patients with disease progression will have the opportunity to receive at least 3 cycles of ofatumumab q4w at an increased dose of 2000 mg in combination with 1000 mg DTIC.

    Reporting group title
    Arm A - Stage 1 - Rescue Arm
    Reporting group description
    		 Patients with disease progression who have well tolerated the Ofatumumab treatment well, had the opportunity to receive at least 3 cycles of ofatumumab q4w at an increased dose (2000 mg) in combination with DTIC (1000mg).

    Serious adverse events
    		 Arm A (Monotherapy) - Stage 1 Arm A - Stage 1 - Rescue Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 8 (12.50%)
         number of deaths (all causes)
    2
    7
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Acute coronary syndrome
    Additional description: Possible relation to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    Hypertension
    Additional description: Probable relation to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anemia
    Additional description: possible relation to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erysipelas
    Additional description: resulting in Sepsis, not related vs.probable related to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (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: 0%
    Non-serious adverse events
    		 Arm A (Monotherapy) - Stage 1 Arm A - Stage 1 - Rescue Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 10 (70.00%)
    2 / 8 (25.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant ascites
    Additional description: unlikely related to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nervous system disorders
    Incoordination
    Additional description: possible relation to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Sinus tachycardia
    Additional description: probable relation to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Anemia
    Additional description: possible relation to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Immune system disorders
    Urticarial rash
    Additional description: certain relation to study drug
         subjects affected / exposed
    5 / 10 (50.00%)
    0 / 8 (0.00%)
         occurrences all number
    5
    0
    Eye disorders
    Retinal detachments and defects
    Additional description: unlikely related to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Anal fissure
    Additional description: unlikely related to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gastroesophageal reflux disease
    Additional description: possible relation to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary hypertension
    Additional description: unlikely related to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Erysipelas
    Additional description: not related to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Exanthem
    Additional description: possible relation to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal artery stenosis
    Additional description: unlikely related to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
    Additional description: not related to study drug
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
    Additional description: assessed as possible to probable relation to study drug
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    1
    Pneumococcal infection
    Additional description: possibly related to study drug
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2011
    Addition of clinical trial site: Prof.Dr.Klemens Rappersberger Rudolfstiftung, Department for Dermatology and Venerology
    13 Mar 2014
    Release of safety warning by GSK Pharma GmbH with respect to risk of HBV reactivation after administration of Arzerra. The warning states that HBV reactivation can occur in patients receiving CD20-directed cytolytic antibodies (including Arzerra), resulting in some cases in fulminant hepatitis, hepatic failure, and death. As a consequence GSK recommends the screening of all patients for HBV infection prior starting Arzerra i.v treatment by measuring HBsAg and HBcAb. Moreover patients with a prior HBV infection who are at risk of HBV reactivation shall be monitored properly.

    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.
    not applicable
    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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