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    Clinical Trial Results:
    Phase IIa/IIb Clinical Trial of NC-6004 in Combination with Pembrolizumab in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed Platinum or a Platinum-containing Regimen

    Summary
    EudraCT number
    2018-003959-37
    Trial protocol
    HU   PL   CZ   HR  
    Global end of trial date
    30 Jun 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Mar 2024
    First version publication date
    15 Mar 2024
    Other versions
    Summary report(s)
    CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    NC-6004-009
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03771820
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Nano Carrier Co, Ltd
    Sponsor organisation address
    Ohnoya-Kyobashi Bldg 1-4-10 Kyobashi, Chuo-ku, Tokyo, Japan, 104-0031
    Public contact
    Study Director, NanoCarrier Co, Ltd., +81 3-3241-0551, osada@nanocarrier.co.jp
    Scientific contact
    Study Director, NanoCarrier Co, Ltd., +81 3-3241-0551, osada@nanocarrier.co.jp
    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
    05 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Part 1(Phase IIa): To assess dose-limiting toxicities (DLTs), and to determine the optimal dose in order to establish the recommended Phase IIb (RPIIb) dose for the combination of NC-6004 plus pembrolizumab. Part 2 (Phase IIb): To compare progression-free survival (PFS) between NC-6004 plus pembrolizumab and pembrolizumab alone.
    Protection of trial subjects
    The study protocol, consent form, participant recruitment process and other relevant study documents were submitted to involved Ethic Committee (ECs)/Independent Ethic Committees (IECs) and approved prior to study initiation. This study was conducted in accordance with principles of the Declaration of Helsinki, with the current Good Clinical Practice guidelines and with other applicable local regulations. The investigators and their study staff conducted the study in compliance with the study protocol and further protocol amendments. Interested participants were given an opportunity to discuss the activities and procedures involved in study participation with the principal investigator and their site staff. An EC-approved informed consent form which was given to the potential subject and an opportunity afforded to read the consent form and ask questions. Those individuals interested in participation were requested to sign the informed consent form prior to the performance of any study-related procedures. The rights, safety, and wellbeing of the study subjects were the most important considerations and prevailed over the interests of science and society. Identifying any untoward medical occurrence and timely and complete reporting of all AEs was aimed at the most efficient protection of the safety of study subjects. Patient's personal, medical and sensitive data were protected in line with general (GDPR) and applicable local data protection regulations.
    Background therapy
    Platinum compounds are well established agents in the treatment of cancer (Kelland and Sharp 1999). The leading platinum compounds in cancer chemotherapy are cisplatin, carboplatin, and oxaliplatin. They share a number of common structural chemical characteristics; however, they exhibit marked interanalogue differences in pharmacokinetics, side effect profiles, and optimal therapeutic indication. Cisplatin has been widely used for the treatment of cancer, including lung cancer (both small cell lung cancer and NSCLC), head and neck cancer, germ-cell tumors (testicular, ovarian, and extragonadal germ cell tumor), ovarian cancer, testicular tumor, bladder cancer, renal pelvis/ureter tumor, prostate cancer, esophagus cancer, cervical cancer, neuroblastoma, stomach cancer, osteosarcoma, and pleura malignant mesothelioma in monotherapy, and malignant bone tumors, endometrial cancer (adjuvant chemotherapy and chemotherapy for metastasis/recurrence), recurrent/refractory malignant lymphoma, and pediatric malignant solid tumors (rhabdomyosarcoma, neuroblastoma, hepatoblastoma, and other primary malignant liver tumors, medulloblastoma) in combination therapy. The mechanism of action of cisplatin is the inhibition of DNA synthesis induced by the platinum-DNA adduct formed by cross-linking between cisplatin and specific base sequences. This cross-linking inhibits DNA replication and transcription and activates signal transduction pathways leading to apoptosis and cell death (Pinto and Lippard 1985).
    Evidence for comparator
    Immune checkpoint inhibitors, such as pembrolizumab, are approved for treatment in people with recurrent or metastatic head and neck cancer who are currently on or have received platinum-containing chemotherapy. In oncology development, there are many ongoing trials that show better efficacy from combination agents have already been developed, showing an acceptable tolerance with a significant clinical activity.
    Actual start date of recruitment
    14 Jun 2019
    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
    Poland: 15
    Country: Number of subjects enrolled
    Croatia: 7
    Country: Number of subjects enrolled
    Czechia: 7
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Taiwan: 13
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Serbia: 38
    Country: Number of subjects enrolled
    Ukraine: 43
    Worldwide total number of subjects
    152
    EEA total number of subjects
    38
    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)
    152
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 220 subjects were screened in this study, 16 subjects in Phase IIa and 204 subjects in Phase IIb. Of 204 subjects screened for Phase IIb, 136 subjects were randomized and 68 subjects were screen failure. Of the 136 subjects, 31 subjects were excluded from the Full Analysis Set (FAS) and 105 subjects received treatment.

    Pre-assignment
    Screening details
    Days -28 -1: ICF, demographic data, medical/surgical/cancer history, disease status, tumor sampling. Days -14 -1: height, weight; body surface area, CT/MRI, ECOG Performance Status, audiometry, ophthalmologist, cardiac risk factor, medications, vaccinations, AEs. Days -7 -1: eligibility criteria, pregnancy test, FSH, physical examination, etc.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    NC-6004 and Pembrolizumab
    Arm description
    In the first arm patients were treated with NC-6004 and Pembrolizumab.
    Arm type
    Experimental

    Investigational medicinal product name
    NC-6004
    Investigational medicinal product code
    Other name
    Cisplatin-PEG-pGlu
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were administered with NC-6004 first followed by pembrolizumab in both parts of the study. The Part 1 phase IIa portion, starting dose was 90 mg/m2 , with subsequent dose escalations to 105 mg/m2 , 120 mg/m2 , and 135 mg/m2 . In phase IIb portion, the dose was to be determined RPII dose in phase IIa portion.

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    L01XC18
    Other name
    KEYTRUDA
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended dose of pembrolizumab was 200 mg administered as an IV infusion over 30 minutes every 3 weeks.

    Arm title
    Pembrolizumab
    Arm description
    In the second arm patients were treated with Pembrolizumab alone.
    Arm type
    Active comparator

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    KEYTRUDA
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The recommended dose of pembrolizumab was 200 mg administered as an IV infusion over 30 minutes every 3 weeks.

    Number of subjects in period 1 [1]
    NC-6004 and Pembrolizumab Pembrolizumab
    Started
    53
    52
    Completed
    0
    0
    Not completed
    53
    52
         Adverse event, serious fatal
    32
    24
         Physician decision
    10
    12
         Consent withdrawn by subject
    7
    5
         Adverse event, non-fatal
    2
    5
         Lost to follow-up
    1
    3
         Progressive disease
    1
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 220 subjects were screened at baseline period this study. Only 152 subjects were enrolled.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NC-6004 and Pembrolizumab
    Reporting group description
    In the first arm patients were treated with NC-6004 and Pembrolizumab.

    Reporting group title
    Pembrolizumab
    Reporting group description
    In the second arm patients were treated with Pembrolizumab alone.

    Reporting group values
    NC-6004 and Pembrolizumab Pembrolizumab Total
    Number of subjects
    53 52 105
    Age categorical
    Males or females aged ≥18 years.
    Units: Subjects
        Adults (18-64 years)
    53 52 105
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
        Not recorded
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    6 9 15
        Male
    47 43 90
    Subject analysis sets

    Subject analysis set title
    Safety Population (SP)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Safety Population (SP) included all participants who received at least one dose of study drug NC-6004 and/or one dose of pembrolizumab. This population was used for analyses of safety data. It was used for summary of baseline data and analyses of progression free survival (PFS).

    Subject analysis set title
    Response Evaluable Population (REP)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Response Evaluable Population (REP) included all participants who received at least one dose of study drug NC-6004 and/or one dose of pembrolizumab, had baseline measurable disease (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]), and had at least one post-baseline radiographic tumor assessment or discontinued study treatment due to clinical progression determined by the site investigator or death if no post-baseline tumor assessment. This population was used for summary of tumor assessment data and analyses of response rates.

    Subject analysis sets values
    Safety Population (SP) Response Evaluable Population (REP)
    Number of subjects
    105
    105
    Age categorical
    Males or females aged ≥18 years.
    Units: Subjects
        Adults (18-64 years)
    105
    105
        From 65-84 years
    0
    0
        85 years and over
    0
    0
        Not recorded
    0
    0
    Age continuous
    Units:
        
    NA ( NA )
    NA ( NA )
    Gender categorical
    Units: Subjects
        Female
    15
    15
        Male
    90
    90

    End points

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    End points reporting groups
    Reporting group title
    NC-6004 and Pembrolizumab
    Reporting group description
    In the first arm patients were treated with NC-6004 and Pembrolizumab.

    Reporting group title
    Pembrolizumab
    Reporting group description
    In the second arm patients were treated with Pembrolizumab alone.

    Subject analysis set title
    Safety Population (SP)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Safety Population (SP) included all participants who received at least one dose of study drug NC-6004 and/or one dose of pembrolizumab. This population was used for analyses of safety data. It was used for summary of baseline data and analyses of progression free survival (PFS).

    Subject analysis set title
    Response Evaluable Population (REP)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Response Evaluable Population (REP) included all participants who received at least one dose of study drug NC-6004 and/or one dose of pembrolizumab, had baseline measurable disease (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]), and had at least one post-baseline radiographic tumor assessment or discontinued study treatment due to clinical progression determined by the site investigator or death if no post-baseline tumor assessment. This population was used for summary of tumor assessment data and analyses of response rates.

    Primary: To establish the Recommended Phase IIb (RPIIb) dose

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    End point title
    To establish the Recommended Phase IIb (RPIIb) dose [1]
    End point description
    To assess (DLTs), and to determine the optimal dose in order to establish the RPIIb dose for the combination of NC 6004 plus pembrolizumab an Independent Data Monitoring Committee was involved in this part. No statistical analyzes planned.
    End point type
    Primary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    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: this study was early terminated.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    53
    52
    Units: number of subjects
    53
    52
    No statistical analyses for this end point

    Primary: To determine the Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

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    End point title
    To determine the Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) [2]
    End point description
    To determine the Progression-free survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in eligible subjects after treatment with NC-6004 plus pembrolizumab and pembrolizumab alone.
    End point type
    Primary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    Notes
    [2] - 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: this study was early terminated.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    53
    52
    Units: number of subjects
    53
    52
    No statistical analyses for this end point

    Secondary: Incidences and severity of SAEs, TEAEs, and discontinuation because of TEAEs

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    End point title
    Incidences and severity of SAEs, TEAEs, and discontinuation because of TEAEs
    End point description
    Incidences and severity of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and discontinuation because of TEAEs
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    53
    52
    Units: number of subjects
    9
    5
    No statistical analyses for this end point

    Secondary: Incidence and severity of laboratory abnormalities

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    End point title
    Incidence and severity of laboratory abnormalities
    End point description
    Incidence and severity of laboratory abnormalities (hematology and biochemistry) according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: number of subjects
    Notes
    [3] - Not done.
    [4] - Not done.
    No statistical analyses for this end point

    Secondary: Change from baseline in vital sign measurements

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    End point title
    Change from baseline in vital sign measurements
    End point description
    Change from baseline in vital sign measurements (blood pressure, heart rate, respiratory rate, and temperature)
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    53
    52
    Units: number of subjects
    53
    52
    No statistical analyses for this end point

    Secondary: Change from baseline in electrocardiogram (ECG) findings

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    End point title
    Change from baseline in electrocardiogram (ECG) findings
    End point description
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    53
    52
    Units: number of subjects
    53
    52
    No statistical analyses for this end point

    Secondary: Overall survival subjects

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    End point title
    Overall survival subjects
    End point description
    OS is defined as the time from randomization/inclusion to death due to any cause or last contact.
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab Response Evaluable Population (REP)
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: Rate
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [5] - Not done.
    [6] - Not done.
    [7] - Not done.
    No statistical analyses for this end point

    Secondary: Overall response rate (ORR)

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    End point title
    Overall response rate (ORR)
    End point description
    ORR is defined as the proportion of subjects who have a complete response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm, or partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. ORR was assessed by performing study imaging at 6 weeks (42 days ±7 days) and again at 12 weeks (84 days ±7 days) from the date of first study dose. Subsequent tumor imaging was performed every 9 weeks (63 days ±7 days) after the last imaging or more frequently if clinically indicated. After 48 weeks, subjects who remain on treatment had imaging performed every 12 weeks (84 days ±7 days) after the last imaging.
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    53
    52
    Units: number of subjects
    53
    52
    No statistical analyses for this end point

    Secondary: Complete response (CR)/ Partial response (PR)

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    End point title
    Complete response (CR)/ Partial response (PR)
    End point description
    CR defined as disappearance of all target and all non-target lesions. All pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. PR defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    53
    52
    Units: number of subjects
    53
    52
    No statistical analyses for this end point

    Secondary: Stable disease (SD)

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    End point title
    Stable disease (SD)
    End point description
    SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: number of subjects
    Notes
    [8] - Not done.
    [9] - Not done.
    No statistical analyses for this end point

    Secondary: Duration of response (DOR)

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    End point title
    Duration of response (DOR)
    End point description
    DOR defined as subjects who demonstrated confirmed CR or PR. DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: number of subjects
    Notes
    [10] - Not done.
    [11] - Not done.
    No statistical analyses for this end point

    Secondary: Time to response (TTR)

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    End point title
    Time to response (TTR)
    End point description
    TTR defined as subject’s first documented response from the date of randomization/inclusion.
    End point type
    Secondary
    End point timeframe
    From the first day of treatment to the end of the follow-up period of the study.
    End point values
    NC-6004 and Pembrolizumab Pembrolizumab
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: days
        number (not applicable)
    Notes
    [12] - Not done.
    [13] - Not done.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From screening to the end of the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24
    Frequency threshold for reporting non-serious adverse events: 3%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The analysis included only TEAEs, i.e., AEs that started or worsened after the start of IMP. All TEAEs, related TEAEs (i.e., TEAEs probably or possibly related to the IMP), and serious TEAEs were summarized and tabulated according to MedDRA primary system organ class and preferred term.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2019
    Protocol updated with regards to the exclusion criteria in connection with comments received from the Hungarian regulatory authority (OGYEI).
    26 Nov 2019
    Protocol submitted only in Taiwan and then updated in line with comments received from Taiwanian FDA, which resulted in creation of Protocol version 4.0 submitted globally.
    04 May 2020
    Main changes: • Clarification of study objectives and endpoints • Clarification of inclusion criteria • Clarification and addition of exclusion criteria upon TFDA request • Change to adaptive randomization • Change in reasons for patient withdrawal from the study due to toxicity upon TFDA request • Change in dose-limiting toxicity criteria upon TFDA request • Clarification of efficacy assessments • Change in prophylactic medication as per FDA recommendation and the Sponsor’s medical monitors recommendation

    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.
    None
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