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    Clinical Trial Results:
    An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy

    Summary
    EudraCT number
    		 2011-003751-19
    Trial protocol
    		 DE   GB   NL   LT   ES  
    Global end of trial date
    27 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions
    Summary report(s)
    		 Clinical Study Report Synopsis PCIA202_10

    Trial information

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    Trial identification
    Sponsor protocol code
    PCIA202/10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01606566
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PCI BIOTECH AS
    Sponsor organisation address
    Ullernchausseen 64, Oslo, Norway, 0369
    Public contact
    Lucy Wabakken , PCI BIOTECH AS, +47 67 11 54 00 , luwa@pcibiotech.no
    Scientific contact
    Dr. Anders Høgset, PhD – Chief Scientific Officer, PCI BIOTECH AS, +47 67 11 54 00,
    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
    31 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    ‘Run-in part’ primary objective: To determine a safe light dose for PC-A11 with interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and eligible for interstitial laser light application ‘Run-in part’ secondary objective: To make a preliminary assessment of efficacy at 3 months To assess the safety and tolerability To characterize the PK To test the QoL ‘Expansion part’ primary objective: To assess the efficacy of PC-A11 with superficial and/or interstitial laser light application in patients with recurrent SCCHN by means of local non-progression rates at 6 months ‘Expansion part’ secondary objectives: To assess efficacy by means of: Local non-progression rate at 3 months Objective Overall Response Rate (ORR) Disease Control Rate (DCR) Progression Free Survival (PFS) Overall Survival (OS) To assess the safety and tolerability To characterize the PK To test the QoL
    Protection of trial subjects
    Patients will be monitored closely for a minimum of 2 hours following Amphinex and bleomycin administration, and placement of interstitial light applicator fibres and laser light application will be performed under general anaesthesia. Patients will be assessed for safety at baseline, as well as during treatment and follow-up visits until disease progression. Close monitoring for interactions of Amphinex with other medicinal products and other forms of interaction will be considered carefully during patient selection and treatment. Product complaints were reported to the sponsor and are considered any oral or written expression of dissatisfaction related to identity, quality, purity, and safety of the medicinal product.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    15 May 2012
    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
    Netherlands: 6
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Lithuania: 2
    Worldwide total number of subjects
    24
    EEA total number of subjects
    18
    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)
    17
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient enrolled: 15 May 2012 Last patient last visit: 27 Aug 2015 Patients recruited at 8 centers

    Pre-assignment
    Screening details
    		 Age ≥18 years, histologically or cytological confirmed diagnosis of recurrent SCCHN, with or without metastasis, considered unsuitable for surgery and radiotherapy, a performance status Eastern Cooperative Oncology Group (ECOG) ≤1 and at least 1 measurable target lesion at Baseline

    Period 1
    Period 1 title
    Pre-expansion, Run-in and Expansion (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 'Pre-expansion’ Part PC-A11 (Pre Amendment 2)
    Arm description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0, followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration. The light source used was a PCI-652 nm laser (CE 0470), emitting red light at 652±2 nm. The laser had 1 channel operating up to 5 W and 6 -+channels operating up to 0.5 W. Superficial laser light applications were performed with a frontal diffuser fiber attached to the 5 W output channel at a light dose of 100 mW and 60 J/cm2. Up to 6 fibers with cylindrical diffuser tips could be connected to the 0.5 W output channels for simultaneous intratumoral laser light application at a light dose of 100 mW and 60 J/cm per fiber.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    N/A
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex at a concentration of 0.25 mg/kg was given as a slow intravenous (i.v.) injection over 1-6 minutes, into a vein not distal to the antecubital fossa, on Day 0.

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    N/A
    Other name
    N/A
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15,000 IU/m2 was given on Day 4 as an i.v. infusion at a rate of 1,000 to 1,500 IU/minute, i.e. over 10-15 minutes

    Arm title
    		 ‘Run-in’ Part: PC-A11 (10 J/cm)
    Arm description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 10 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    N/A
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex at a concentration of 0.25 mg/kg was given as a slow intravenous (i.v.) injection over 1-6 minutes, into a vein not distal to the antecubital fossa, on Day 0.

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    N/A
    Other name
    N/A
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15,000 IU/m2 was given on Day 4 as an i.v. infusion at a rate of 1,000 to 1,500 IU/minute, i.e. over 10-15 minutes

    Arm title
    		 'Run-in’ Part: PC-A11 (20 J/cm)
    Arm description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 20 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    N/A
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex at a concentration of 0.25 mg/kg was given as a slow intravenous (i.v.) injection over 1-6 minutes, into a vein not distal to the antecubital fossa, on Day 0.

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    N/A
    Other name
    N/A
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15,000 IU/m2 was given on Day 4 as an i.v. infusion at a rate of 1,000 to 1,500 IU/minute, i.e. over 10-15 minutes

    Arm title
    		 ‘Run-in’ Part: PC-A11 (30 J/cm)
    Arm description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 30 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    N/A
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex at a concentration of 0.25 mg/kg was given as a slow intravenous (i.v.) injection over 1-6 minutes, into a vein not distal to the antecubital fossa, on Day 0.

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    N/A
    Other name
    N/A
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15,000 IU/m2 was given on Day 4 as an i.v. infusion at a rate of 1,000 to 1,500 IU/minute, i.e. over 10-15 minutes

    Arm title
    		 ‘Expansion’ Part: PC-A11
    Arm description
    		 Patients received a single dose of Amphinex 30 mg/mL (at a dose of 0.25 mg/kg) on Day 0. The bleomycin component of PC-A11 was administered intravenously at a dose of 15000 IU/m2 on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration using the PCI-652 nm red light laser at a light dose of 100 mW and 60 J/cm2, using a single linear diffuser fiber.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    N/A
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex at a concentration of 0.25 mg/kg was given as a slow intravenous (i.v.) injection over 1-6 minutes, into a vein not distal to the antecubital fossa, on Day 0.

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    N/A
    Other name
    N/A
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15,000 IU/m2 was given on Day 4 as an i.v. infusion at a rate of 1,000 to 1,500 IU/minute, i.e. over 10-15 minutes

    Number of subjects in period 1
    		'Pre-expansion’ Part PC-A11 (Pre Amendment 2) ‘Run-in’ Part: PC-A11 (10 J/cm) 'Run-in’ Part: PC-A11 (20 J/cm) ‘Run-in’ Part: PC-A11 (30 J/cm) ‘Expansion’ Part: PC-A11
    Started
    6
    3
    7
    1
    7
    Completed
    3
    1
    5
    1
    4
    Not completed
    3
    2
    2
    0
    3
         Disease progression
    1
    -
    1
    -
    1
         Lost to follow-up
    -
    -
    1
    -
    -
         Lack of efficacy
    2
    2
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    'Pre-expansion’ Part PC-A11 (Pre Amendment 2)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0, followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration. The light source used was a PCI-652 nm laser (CE 0470), emitting red light at 652±2 nm. The laser had 1 channel operating up to 5 W and 6 -+channels operating up to 0.5 W. Superficial laser light applications were performed with a frontal diffuser fiber attached to the 5 W output channel at a light dose of 100 mW and 60 J/cm2. Up to 6 fibers with cylindrical diffuser tips could be connected to the 0.5 W output channels for simultaneous intratumoral laser light application at a light dose of 100 mW and 60 J/cm per fiber.

    Reporting group title
    ‘Run-in’ Part: PC-A11 (10 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 10 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    'Run-in’ Part: PC-A11 (20 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 20 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    ‘Run-in’ Part: PC-A11 (30 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 30 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    ‘Expansion’ Part: PC-A11
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL (at a dose of 0.25 mg/kg) on Day 0. The bleomycin component of PC-A11 was administered intravenously at a dose of 15000 IU/m2 on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration using the PCI-652 nm red light laser at a light dose of 100 mW and 60 J/cm2, using a single linear diffuser fiber.

    Reporting group values
    		 'Pre-expansion’ Part PC-A11 (Pre Amendment 2) ‘Run-in’ Part: PC-A11 (10 J/cm) 'Run-in’ Part: PC-A11 (20 J/cm) ‘Run-in’ Part: PC-A11 (30 J/cm) ‘Expansion’ Part: PC-A11 Total
    Number of subjects
    		 6 3 7 1 7 24
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 53.7 (44 to 74) 52.3 (43 to 59) 59.7 (52 to 66) 51.0 (51 to 51) 70.0 (58 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 4 0 2 9
        Male
    		 4 2 3 1 5 15
    Race, n (%)
    Units: Subjects
        White
    		 6 3 7 1 7 24
    Fitzpatrick skin type, n (%)
    Units: Subjects
        1.
    		 1 0 0 0 1 2
        2.
    		 0 2 2 1 4 9
        3.
    		 3 1 5 0 1 10
        4.
    		 2 0 0 0 0 2
        5.
    		 0 0 0 0 1 1
        6.
    		 0 0 0 0 0 0
    Tobacco consumption, n (%)
    Units: Subjects
        Has never smoked
    		 2 0 1 0 0 3
        Has previously smoked
    		 4 1 0 0 3 8
        Patient currently smokes
    		 0 2 6 1 4 13
    Alcohol consumption, n (%)
    Units: Subjects
        Has never consumed alcohol
    		 1 0 2 0 2 5
        Has previously consumed alcohol
    		 4 2 3 1 2 12
        Once a week
    		 0 0 1 0 1 2
        Daily
    		 1 1 1 0 2 5
    BMI (kg/m^2)
    Units: kg/m^2
        arithmetic mean (full range (min-max))
    		 22.33 (10.3 to 28.0) 19.29 (16.2 to 21.6) 19.98 (16.5 to 29.2) 26.7 (26.7 to 26.7) 22.49 (19.2 to 29.9) -

    End points

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    End points reporting groups
    Reporting group title
    'Pre-expansion’ Part PC-A11 (Pre Amendment 2)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0, followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration. The light source used was a PCI-652 nm laser (CE 0470), emitting red light at 652±2 nm. The laser had 1 channel operating up to 5 W and 6 -+channels operating up to 0.5 W. Superficial laser light applications were performed with a frontal diffuser fiber attached to the 5 W output channel at a light dose of 100 mW and 60 J/cm2. Up to 6 fibers with cylindrical diffuser tips could be connected to the 0.5 W output channels for simultaneous intratumoral laser light application at a light dose of 100 mW and 60 J/cm per fiber.

    Reporting group title
    ‘Run-in’ Part: PC-A11 (10 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 10 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    'Run-in’ Part: PC-A11 (20 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 20 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    ‘Run-in’ Part: PC-A11 (30 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 30 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    ‘Expansion’ Part: PC-A11
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL (at a dose of 0.25 mg/kg) on Day 0. The bleomycin component of PC-A11 was administered intravenously at a dose of 15000 IU/m2 on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration using the PCI-652 nm red light laser at a light dose of 100 mW and 60 J/cm2, using a single linear diffuser fiber.

    Primary: Dose-limiting toxicities (DLTs)

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    End point title
    		 Dose-limiting toxicities (DLTs) [1] [2]
    End point description
    Run-In Part: Dose-limiting toxicities (DLT) and the safety profile of PC-A11 in patients undergoing intratumoral laser light application.
    End point type
    Primary
    End point timeframe
    4 weeks after laser light application
    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 Statistical analyses for this endpoint. No formal statistical analyses were performed due to the study termination resulting in too few patients being eligible for analysis.
    [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: DLTs were only analysed in the 'run in' cohorts of patients.
    End point values
    		 ‘Run-in’ Part: PC-A11 (10 J/cm) 'Run-in’ Part: PC-A11 (20 J/cm) ‘Run-in’ Part: PC-A11 (30 J/cm)
    Number of subjects analysed
    3
    7
    1
    Units: Patients
        DLTs
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Safety Endpoint: AEs

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    End point title
    		 Safety Endpoint: AEs
    End point description
    Proportion of patients with adverse events (in the period of observation, as defined above).
    End point type
    Secondary
    End point timeframe
    Period of observation for all AEs: from date of informed consent until 3 months after laser light application.
    End point values
    		 'Pre-expansion’ Part PC-A11 (Pre Amendment 2) ‘Run-in’ Part: PC-A11 (10 J/cm) 'Run-in’ Part: PC-A11 (20 J/cm) ‘Run-in’ Part: PC-A11 (30 J/cm) ‘Expansion’ Part: PC-A11
    Number of subjects analysed
    6
    3
    7
    1
    7
    Units: Patients
        TEAEs
    6
    3
    7
    1
    6
        SAEs
    5
    1
    4
    0
    2
        Discontinuations due to TEAEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Safety endpoint: VAS

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    End point title
    		 Safety endpoint: VAS
    End point description
    Pain scored by a visual analogue scale (VAS) Maximal pain was recorded on a 10 centimetre visual analogue scale (VAS) provided in the CRF. The end-points of the VAS were “no pain” and “unbearable pain”
    End point type
    Secondary
    End point timeframe
    At baseline, after PC-A11 treatment and during follow up visits.
    End point values
    		 'Pre-expansion’ Part PC-A11 (Pre Amendment 2) ‘Run-in’ Part: PC-A11 (10 J/cm) 'Run-in’ Part: PC-A11 (20 J/cm) ‘Run-in’ Part: PC-A11 (30 J/cm) ‘Expansion’ Part: PC-A11
    Number of subjects analysed
    6
    3
    7
    1
    7
    Units: Patients
        TEAEs related to pain
    2
    0
    6
    1
    4
        SAEs related to pain
    2
    0
    0
    0
    0
        Discontinuations due to TEAEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Date of informed consent until 3 months after laser light application. After period of observation the adverse event is serious and for which a causal relationship to the study treatment cannot be ruled out and all deaths not due to disease progression.
    Adverse event reporting additional description
    An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Pre-expansion’ Part PC-A11 (Pre Amendment 2)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0, followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration . The light source used was a PCI-652 nm laser (CE 0470), emitting red light at 652±2 nm. The laser had 1 channel operating up to 5 W and 6 -+channels operating up to 0.5 W. Superficial laser light applications were performed with a frontal diffuser fiber attached to the 5 W output channel at a light dose of 100 mW and 60 J/cm2. Up to 6 fibers with cylindrical diffuser tips could be connected to the 0.5 W output channels for simultaneous intratumoral laser light application at a light dose of 100 mW and 60 J/cm per fiber.

    Reporting group title
    ‘Run-in’ Part: PC-A11 (10 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 10 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    Run-in’ Part: PC-A11 (20 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 20 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    ‘Run-in’ Part: PC-A11 (30 J/cm)
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL at a fimaporfin (active substance in Amphinex) dose of 0.25 mg/kg on Day 0 followed by bleomycin administration (at a dose of 15000 IU/m2) on Day 4. Tumors were treated with intratumoral light illumination with a light dose of 30 J/cm cylindrical light diffuser fiber, 3 hours (±1 hour) after bleomycin administration.

    Reporting group title
    ‘Expansion’ Part: PC-A11
    Reporting group description
    		 Patients received a single dose of Amphinex 30 mg/mL (at a dose of 0.25 mg/kg) on Day 0. The bleomycin component of PC-A11 was administered intravenously at a dose of 15000 IU/m2 on Day 4. Laser light application was performed 3 hours (±1 hour) after bleomycin administration using the PCI-652 nm red light laser at a light dose of 100 mW and 60 J/cm2, using a single linear diffuser fiber.

    Serious adverse events
    		 Pre-expansion’ Part PC-A11 (Pre Amendment 2) ‘Run-in’ Part: PC-A11 (10 J/cm) Run-in’ Part: PC-A11 (20 J/cm) ‘Run-in’ Part: PC-A11 (30 J/cm) ‘Expansion’ Part: PC-A11
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    1 / 3 (33.33%)
    4 / 7 (57.14%)
    0 / 1 (0.00%)
    2 / 7 (28.57%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Soft tissue injury
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypoperfusion
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Fistula repair
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrostomy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain management
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotherapy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrosis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Obstructive airways disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pre-expansion’ Part PC-A11 (Pre Amendment 2) ‘Run-in’ Part: PC-A11 (10 J/cm) Run-in’ Part: PC-A11 (20 J/cm) ‘Run-in’ Part: PC-A11 (30 J/cm) ‘Expansion’ Part: PC-A11
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    3 / 3 (100.00%)
    7 / 7 (100.00%)
    1 / 1 (100.00%)
    6 / 7 (85.71%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oncologic complication
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Peripheral coldness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    0
    1
    Haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 1 (100.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    6 / 7 (85.71%)
    1 / 1 (100.00%)
    4 / 7 (57.14%)
         occurrences all number
    4
    0
    13
    3
    10
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    0
    0
    2
    Fatigue
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    3 / 7 (42.86%)
    1 / 1 (100.00%)
    2 / 7 (28.57%)
         occurrences all number
    1
    0
    3
    1
    2
    Swelling
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    1 / 1 (100.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Application site pain
         subjects affected / exposed
    4 / 6 (66.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    7
    0
    0
    0
    1
    Application site scab
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Feeling cold
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 1 (100.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    4
    0
    1
    0
    1
    Facial Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Face oedema
         subjects affected / exposed
    5 / 6 (83.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    9
    0
    0
    0
    0
    General physical health deterioration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Local Swelling
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    3
    0
    3
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    2
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Pharyngeal oedema
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Depression mood
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Hallucination
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Overdose
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 1 (100.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Procedural pain
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Post procedural swelling
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Thermal burn
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Excoriation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    0
    0
    1
    VIth nerve paralysis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Amnesia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Coordination abnormal
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 1 (100.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    2
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    3 / 7 (42.86%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    4
    0
    1
    Constipation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    4 / 7 (57.14%)
         occurrences all number
    0
    0
    3
    0
    4
    Diarrhoea
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    3 / 7 (42.86%)
    0 / 1 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    1
    1
    6
    0
    2
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    1
    1
    0
    0
    2
    Lip pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Oral pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    2
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Tongue oedema
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    2
    0
    0
    0
    1
    Swollen tongue
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    3 / 6 (50.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Swelling face
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    3 / 7 (42.86%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    6
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    1 / 1 (100.00%)
    2 / 7 (28.57%)
         occurrences all number
    1
    0
    1
    3
    5
    Blister
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    4 / 6 (66.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    1
    0
    0
    Skin chapped
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin burning sensation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Fistula
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Trismus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    9
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Exposed bone in jaw
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Soft tissue necrosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Localised infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    1 / 1 (100.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Oral infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin graft infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Mar 2013
    UK -Protocol version 2.0 dated 07 Mar 2013 - Changed selected inclusion and exclusion criteria, changed the Coordinating Investigator, changed the number of patients and number and location of participating sites and made various other non-substantial changes. This amendment implemented the ‘Run-in’ part for intratumoral laser light application.
    11 Mar 2013
    France - Protocol version 2.0 dated 31 May 2013 - changed selected inclusion and exclusion criteria, changed the Coordinating Investigator, changed the number of patients and number and location of participating sites and made various other non-substantial changes. This amendment implemented the ‘Run-in’ part for intratumoral laser light application.
    11 Mar 2013
    Netherlands - Protocol version 2.0 dated 15 April 2013 - changed selected inclusion and exclusion criteria, changed the Coordinating Investigator, changed the number of patients and number and location of participating sites and made various other non-substantial changes. This amendment implemented the ‘Run-in’ part for intratumoral laser light application.
    11 Mar 2013
    Netherlands - Protocol version 2.0 dated 07 May 2013 - changed selected inclusion and exclusion criteria, changed the Coordinating Investigator, changed the number of patients and number and location of participating sites and made various other non-substantial changes. This amendment implemented the ‘Run-in’ part for intratumoral laser light application.
    09 Jun 2014
    Protocol version 3.0 dated 09 June 2014 - This amendment changed an exclusion criterion, added determination of human papilloma virus (HPV) status for all patients, and changed the time point for an optional tumor biopsy for biomarker analysis.
    16 Mar 2015
    Protocol version 4.0 dated 16 March 2015 - This amendment extended the treatment margin for intra-tumor light application, removed a requirement of a maximum of 10 fibers to be used for intra tumor light application and added an assessment of immune modulating effects of Amphinex.

    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.
    The dose optimization for intratumoral light application was more complicated than anticipated. Study was terminated due to increased complexity of the treatment with extended treatment margins and the emerging, very promising, immunotherapy data.
    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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