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    Clinical Trial Results:
    A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions.

    Summary
    EudraCT number
    		 2012-001991-13
    Trial protocol
    		 IT  
    Global end of trial date
    26 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2022
    First version publication date
    13 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PH-L19IL2TNF-02/12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02076633
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 INTRACOMBO PHASE 2: PH-L19IL2TNF-02/12
    Sponsors
    Sponsor organisation name
    Philogen S.p.A.
    Sponsor organisation address
    Località Bellaria, 35, Sovicille (SI), Italy, 53018
    Public contact
    Regulatory Affairs Department, Philogen S.p.A., +39 057717816, regulatory@philogen.com
    Scientific contact
    Regulatory Affairs Department, Philogen S.p.A., +39 057717816, regulatory@philogen.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
    18 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of L19IL2/L19TNF-treated lesions measured as rate of patients with complete response (CR) at week 12 (day 85).
    Protection of trial subjects
    Safety of the patients was carefully evaluated during all the period in which the patient was in the study. During the active treatment phase, regular laboratory analysis of the common clinical parameters were performed, as also physical examination and vital signs monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2012
    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
    Italy: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    11
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 22 patients were enrolled from 05.12.2012 to 23.05.2014: 13 at the Milan site and 9 at the Siena site.

    Pre-assignment
    Screening details
    		 After obtaining patient informed consent, screening evaluations and procedures had to be performed within 14 days prior to the start of therapy. At the screening visit, a full evaluation of the status of patient was performed. Based on the information obtained from the assessments, the patient's eligibility was decided upon.

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

    Arms
    Arm title
    		 Single arm
    Arm description
    		 Patients were treated with a combination of 10 Mio IU of L19IL2 and 312 μg of L19TNF to be administered in an approximate volume of 4.2 ml as a single or multiple intratumoral injection once every week for up to 4 weeks. L19IL2 was dosed at 10 Mio IU per administration, the amount of L19TNF per administration was 312 μg. However, the dose could be adjusted between 78 and 312 μg per administration according to size and number of lesions and at the investigator's discretion. The total daily dose was distributed between all injectable soft-tissue metastases.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Onfekafusp alfa
    Investigational medicinal product code
    L19TNF
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    Up to 312 μg of L19TNF intratumoral injection once every week for up to 4 weeks.

    Investigational medicinal product name
    Bifikafusp alfa
    Investigational medicinal product code
    L19IL2
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    10 Mio IU of L19IL2 intratumoral injection once every week for up to 4 weeks.

    Number of subjects in period 1
    		Single arm
    Started
    22
    Completed
    7
    Not completed
    15
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    1
         surgery of residual metastatic lesions
    6
         Progressive disease
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 22 22
    Age categorical
    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)
    		 11 11
        From 65-84 years
    		 11 11
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 64 ( 15.22 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 10 10
    Subject analysis sets

    Subject analysis set title
    Safety Evaluable Population (SE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All eligible patients who received at least one dose of the study treatment. An incorrect drug administration or an early termination of treatment did not result in exclusion of patients from this population.

    Subject analysis set title
    Efficacy Evaluable Population (EE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All eligible patients who received at least one dose of the study treatment and had at least one post-treatment tumor assessment

    Subject analysis set title
    Not evaluable patients for efficacy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Not evaluable patients for efficacy

    Subject analysis sets values
    		 Safety Evaluable Population (SE) Efficacy Evaluable Population (EE) Not evaluable patients for efficacy
    Number of subjects
    22
    20
    2
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    11
    10
        From 65-84 years
    11
    10
        85 years and over
    Age continuous
    Units: years
        median (standard deviation)
    64 ( 15.22 )
    61.5 ( 15.44 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    12
    11
        Male
    10
    9

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 Patients were treated with a combination of 10 Mio IU of L19IL2 and 312 μg of L19TNF to be administered in an approximate volume of 4.2 ml as a single or multiple intratumoral injection once every week for up to 4 weeks. L19IL2 was dosed at 10 Mio IU per administration, the amount of L19TNF per administration was 312 μg. However, the dose could be adjusted between 78 and 312 μg per administration according to size and number of lesions and at the investigator's discretion. The total daily dose was distributed between all injectable soft-tissue metastases.

    Subject analysis set title
    Safety Evaluable Population (SE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All eligible patients who received at least one dose of the study treatment. An incorrect drug administration or an early termination of treatment did not result in exclusion of patients from this population.

    Subject analysis set title
    Efficacy Evaluable Population (EE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All eligible patients who received at least one dose of the study treatment and had at least one post-treatment tumor assessment

    Subject analysis set title
    Not evaluable patients for efficacy
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Not evaluable patients for efficacy

    Primary: Evaluation of the efficacy of L19IL2/L19TNF-treated lesions measured as rate of patients with complete response (CR) at week 12

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    End point title
    		 Evaluation of the efficacy of L19IL2/L19TNF-treated lesions measured as rate of patients with complete response (CR) at week 12
    End point description
    The primary objective of the study is to evaluate the efficacy of L19IL2/L19TNF-treated lesions measured as rate of patients with complete response (CR) at week 12 (day 85).
    End point type
    Primary
    End point timeframe
    From day 1 to week 12
    End point values
    		 Efficacy Evaluable Population (EE) Not evaluable patients for efficacy
    Number of subjects analysed
    20
    2
    Units: Subjects
    2
    0
    Statistical analysis title
    		 Two-sided exact binomial statistical test
    Statistical analysis description
    A two-sided exact binomial statistical test was applied for the rate of patients with CR, OR, and DC of the L19IL2/L19TNF-treated lesions and all lesions for all the available tumor assessments. The hypothesized value for the null hypothesis was 50%. The duration of OR and DC was calculated using Kaplan Meier estimator for the treated lesions and for all the lesions.
    Comparison groups
    Efficacy Evaluable Population (EE) v Not evaluable patients for efficacy
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0003
    Method
    		 Binomial test
    Confidence interval

    Secondary: Objective response rate (ORR) at week 12 for injected lesions

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    End point title
    		 Objective response rate (ORR) at week 12 for injected lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated lesions based on Objective Response Rate (ORR) (that being, CR and partial response [PR])
    End point type
    Secondary
    End point timeframe
    From day 1 to week 12
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    12
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR) at week 24 for injected lesions

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    End point title
    		 Objective response rate (ORR) at week 24 for injected lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated lesions based on Objective Response Rate (ORR) (that being, CR and partial response [PR])
    End point type
    Secondary
    End point timeframe
    From day 1 to week 24
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    8
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR) at week 36 for injected lesions

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    End point title
    		 Objective response rate (ORR) at week 36 for injected lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated lesions based on Objective Response Rate (ORR) (that being, CR and partial response [PR])
    End point type
    Secondary
    End point timeframe
    From day 1 to week 36
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    7
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR) at week 24 for injected lesions

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    End point title
    		 Disease control rate (DCR) at week 24 for injected lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated lesions based on Disease Control Rate (DCR) (that being, CR, PR and stable disease [SD])
    End point type
    Secondary
    End point timeframe
    From day 1 to week 24
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    11
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR) at week 12 for injected lesions

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    End point title
    		 Disease control rate (DCR) at week 12 for injected lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated lesions based on Disease Control Rate (DCR) (that being, CR, PR and stable disease [SD])
    End point type
    Secondary
    End point timeframe
    From day 1 to week 12
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    16
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR) at week 36 for injected lesions

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    End point title
    		 Disease control rate (DCR) at week 36 for injected lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated lesions based on Disease Control Rate (DCR) (that being, CR, PR and stable disease [SD])
    End point type
    Secondary
    End point timeframe
    From day 1 to week 36
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    11
    No statistical analyses for this end point

    Secondary: Duration of disease control for injected lesions

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    End point title
    		 Duration of disease control for injected lesions
    End point description
    Assessment of the duration of disease control (DC) in patients with treated lesions
    End point type
    Secondary
    End point timeframe
    From day 1 to end of study
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Days
        median (confidence interval 95%)
    346 (176 to 999999999999999.9999999999)
    No statistical analyses for this end point

    Secondary: Duration of objective response for injected lesions

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    End point title
    		 Duration of objective response for injected lesions
    End point description
    Assessment of the duration of objective response (OR) in patients with treated lesions
    End point type
    Secondary
    End point timeframe
    From day 1 to end of study
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Days
        median (confidence interval 95%)
    309 (75 to 999999999999999.9999999999)
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR) at week 12 for treated and non-treated lesions

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    End point title
    		 Disease control rate (DCR) at week 12 for treated and non-treated lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated and non-treated lesions based on Disease Control Rate (DCR)
    End point type
    Secondary
    End point timeframe
    From day 1 to week 12
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    15
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR) at week 24 for treated and non-treated lesions

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    End point title
    		 Disease control rate (DCR) at week 24 for treated and non-treated lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated and non-treated lesions based on Disease Control Rate (DCR)
    End point type
    Secondary
    End point timeframe
    From day 1 to week 24
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    10
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR) at week 36 for treated and non-treated lesions

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    End point title
    		 Disease control rate (DCR) at week 36 for treated and non-treated lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated and non-treated lesions based on Disease Control Rate (DCR)
    End point type
    Secondary
    End point timeframe
    From day 1 to week 36
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    10
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR) at week 12 for treated and non-treated lesions

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    End point title
    		 Objective response rate (ORR) at week 12 for treated and non-treated lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated and non-treated lesions based on Objective Response Rate (ORR)
    End point type
    Secondary
    End point timeframe
    From day 1 to week 12
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    12
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR) at week 24 for treated and non-treated lesions

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    End point title
    		 Objective response rate (ORR) at week 24 for treated and non-treated lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated and non-treated lesions based on Objective Response Rate (ORR)
    End point type
    Secondary
    End point timeframe
    From day 1 to week 24
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    8
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR) at week 36 for treated and non-treated lesions

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    End point title
    		 Objective response rate (ORR) at week 36 for treated and non-treated lesions
    End point description
    Assessment of the efficacy of L19IL2/L19TNF on treated and non-treated lesions based on Objective Response Rate (ORR)
    End point type
    Secondary
    End point timeframe
    From day 1 to week 36
    End point values
    		 Efficacy Evaluable Population (EE)
    Number of subjects analysed
    20
    Units: Subjects
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the signature of the ICF to the end of the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Safety set (SAF)
    Reporting group description
    		 -

    Serious adverse events
    		 Safety set (SAF)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    INJECTION SITE REACTION
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety set (SAF)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 22 (95.45%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    FATIGUE
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    CHILLS
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    6
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    INJECTION SITE PAIN
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    INJECTION SITE REACTION
         subjects affected / exposed
    19 / 22 (86.36%)
         occurrences all number
    44
    MALAISE
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    LOCALISED OEDEMA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    PYREXIA
         subjects affected / exposed
    14 / 22 (63.64%)
         occurrences all number
    31
    OEDEMA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    PAIN
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Reproductive system and breast disorders
    VULVOVAGINAL PRURITUS
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    ALLERGIC PHARYNGITIS
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    DYSPNOEA
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    COUGH
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    SEROMA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    JOINT SPRAIN
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    11 / 22 (50.00%)
         occurrences all number
    13
    MUSCLE CONTRACTIONS INVOLUNTARY
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    3
    MYOCLONUS
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    PRESYNCOPE
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    5
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    DIARRHOEA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    FAECAL INCONTINENCE
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    NAUSEA
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    5
    VOMITING
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    HYPERHIDROSIS
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    ERYTHEMA
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    RASH
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    Renal and urinary disorders
    URINARY INCONTINENCE
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    FLANK PAIN
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Infections and infestations
    HERPES ZOSTER
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    HYPERURICAEMIA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    HYPOKALAEMIA
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    DECREASED APPETITE
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1

    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.
    N.A.
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