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    Summary
    EudraCT Number:2020-005231-78
    Sponsor's Protocol Code Number:MO42541
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-005231-78
    A.3Full title of the trial
    A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB WITH LENVATINIB OR SORAFENIB VERSUS LENVATINIB OR SORAFENIB ALONE IN HEPATOCELLULAR CARCINOMA PREVIOUSLY TREATED WITH ATEZOLIZUMAB AND BEVACIZUMAB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab with Lenvatinib or Sorafenib versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
    A.3.2Name or abbreviated title of the trial where available
    IMbrave251
    A.4.1Sponsor's protocol code numberMO42541
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtezolizumab
    D.3.2Product code RO5541267
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lenvima
    D.2.1.1.2Name of the Marketing Authorisation holderEisai GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLenvatinib
    D.3.2Product code RO7071618
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLenvatinib
    D.3.9.1CAS number 417716-92-8
    D.3.9.2Current sponsor codeRO7071618
    D.3.9.3Other descriptive nameLENVATINIB
    D.3.9.4EV Substance CodeSUB64419
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSorafenib
    D.3.2Product code RO4475417
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSORAFENIB
    D.3.9.1CAS number 284461-73-0
    D.3.9.2Current sponsor codeRO4475417
    D.3.9.4EV Substance CodeSUB23139
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable hepatocellular carcinoma (HCC)
    E.1.1.1Medical condition in easily understood language
    HCC is the most common type of primary liver cancer. It is different from "secondary" liver cancers, which have spread to the liver from other organs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone, based on overall survival (OS)
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared to lenvatinib or sorafenib alone, based on progression free survival (PFS), confirmed objective response rate (ORR), time to progression (TTP) and duration of response (DOR), time to deterioration (TTD), of health-related quality of life (HRQoL)
    •To evaluate patient-reported function and general health status/quality of life (GHS/QoL) experienced by patients receiving atezolizumab plus lenvatinib or sorafenib versus lenvatinib or sorafenib alone
    •To evaluate the safety of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone
    •To characterize the pharmacokinetic (PK) profile of atezolizumab when given in combination with lenvatinib or sorafenib
    •To evaluate the immune response to atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age >=18 and <=75 years at time of signing Informed Consent Form
    •Ability to comply with the study protocol, in the investigator's judgment
    •Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients
    •Patients without cirrhosis require histological confirmation of diagnosis. HCC must be unamenable to curative surgical and/or locoregional therapies, or have progressed after surgical and /or locoregional therapies
    •Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, or 2 subsequent tumor assessments, whichever is longer
    •At least one measurable (per response evaluation criteria in solid tumors version 1.1 [RECIST v1.1]) target lesion, that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1
    •Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 7 days prior to randomization
    •Child-Pugh class A within 7 days prior to randomization
    •Adequate hematologic and end-organ function, obtained within 7 days prior to randomization
    •Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade <=1 prior to study entry, except for alopecia
    •Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) serology tests
    •Patients with active HBV must have HBV DNA < 500 international units per milliliter (IU/mL) obtained within 28 days prior to initiation of study treatment and received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
    •Agree to use protocol defined methods of contraceptions.
    E.4Principal exclusion criteria
    •Symptomatic, untreated, or actively progressing central nervous system metastases
    •History of leptomeningeal disease
    •History of hepatic encephalopathy
    •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
    •History of malignancy other than HCC within 5 years prior to screening
    •Patients receiving any TKI or PD-1/PD-L1 antibody (excluding atezolizumab)
    •Prior treatment with CD137 agonists or immune checkpoint blockade therapies
    •Patients on a liver transplantation list
    •Uncontrolled tumor-related pain
    •Moderate or severe ascites
    •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    •Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume
    •Co-infection of HBV and HCV
    •Active tuberculosis
    •Severe infection within 4 weeks prior to study start
    •Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to study start
    •Treatment with a live, attenuated vaccine within 4 weeks prior to study start, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab
    •Active or history of autoimmune disease or immune deficiency
    •History of idiopathic pulmonary fibrosis, organizing pneumonia, history of non-infectious pneumonitis requiring steroids, or patients with Grade >=2 pneumonitis, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    •Significant cardiovascular disease within 3 months prior to initiation of study treatment
    •Uncontrolled hypertension or inadequately controlled arterial hypertension
    •Significant vascular disease within 6 months prior to initiation of study treatment
    •Thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug
    •Evidence of bleeding diathesis or significant coagulopathy
    •Esophageal or variceal bleeding
    •Patients with signs of portal hypertension/signs of portal hypertension in CT scans
    •History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment
    •History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction
    •History of intra-abdominal inflammatory process within 6 months prior to study start
    •Prior allogeneic stem cell or solid organ transplantation
    •Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
    •Radiotherapy within 28 days and abdominal/pelvic radiotherapy within 60 days prior to study start
    •Local therapy to liver within 28 days prior to study start
    •History of uncorrectable electrolyte disorder affecting serum levels of potassium, calcium, or magnesium
    •Uncontrolled hypercalcemia
    •Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents
    •Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID)
    •Treatment with strong CYP3A4 inducers within 14 days prior to initiation of study treatment
    •Treatment with systemic immunostimulatory within 4 weeks or 5 half-lives of the drug prior to study start
    •Treatment with systemic immunosuppressive medication
    •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
    •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
    •Known allergy or hypersensitivity to any of the investigational medicinal product or constituents of the products
    E.5 End points
    E.5.1Primary end point(s)
    OS, defined as the time from randomization into the study to death from any cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 42 months
    E.5.2Secondary end point(s)
    1.PFS, defined as the time from randomization into the study to the first occurrence of disease progression or death from any cause
    2.ORR, defined as the proportion of patients with a best response of either complete or partial response
    3.TTP, defined as the time from randomization to the first occurrence of disease progression
    4.DOR, defined as the time from the first occurrence of a documented confirmed objective response to disease progression or death from any cause
    5.Time to deterioration (TTD), of health-related quality of life (HRQoL), defined as the time from randomization to first deterioration
    6.Incidence and severity of adverse events (AEs), with severity determined according to national cancer institute common terminology criteria for adverse events version 5.0 (NCI CTCAE v5.0)
    7.Incidence and severity of AEs for combination treatment, AEs related against atezolizumab and TKI-related AEs according to NCI CTCAE v5.0
    8.Incidence of vital sign abnormalities
    9.Incidence of clinical laboratory abnormalities
    10.Serum concentration of atezolizumab at specified timepoints
    11.Prevalence of anti-drug antibodies (ADAs) against atezolizumab at time of study entry
    12.Incidence of ADAs against atezolizumab during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-9.Approximately 42 months
    10.Day 1 of Cycle 1, 2, 3, 4, 8, 12 and 15 and at treatment/surveillance discontinuation visit
    11.At Baseline (Day -28 to Day -1)
    12.Day 1 of Cycle 1, 2, 3, 4, 8, 12 and 15 and at treatment/surveillance discontinuation visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker and Health status objectives
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Canada
    Chile
    China
    Costa Rica
    Egypt
    Israel
    Japan
    Korea, Republic of
    Philippines
    Russian Federation
    Taiwan
    Turkey
    Austria
    Belgium
    Croatia
    Finland
    France
    Germany
    Greece
    Italy
    Slovenia
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of this study is defined as the date when the last patient, last visit (LPLV) or safety
    follow-up is received from the last patient, whichever occurs later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 415
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 139
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In the Master ICF it is included the document for legal representatives to sign in case subjects are not able to consent themselves.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 277
    F.4.2.2In the whole clinical trial 554
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor will offer continued access to Roche IMP (atezolizumab) free of charge to eligible patients in accordance with the Roche Global Policy on
    Continued Access to Investigational Medicinal Product available at the following Web site: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-03
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    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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