Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44132   clinical trials with a EudraCT protocol, of which   7324   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001072-37
    Sponsor's Protocol Code Number:IRFMN-EN-7556
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-08
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-001072-37
    A.3Full title of the trial
    AtTEnd: Atezolizumab Trial in Endometrial cancer - Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with paclitaxel and carboplatin in women with advanced/recurrent endometrial cancer.
    Eine doppelblinde, randomisierte, Placebo-kontrollierte, Phase III Studie zur Anwendung von Atezolizumab in Kombination mit Paclitaxel und Carboplatin bei Frauen mit fortgeschrittenem oderrezidivierendem Endometriumkarzinom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International study that compares a chemotherapy regimen with atezolizumab, paclitaxel and carboplatin versus a regimen with placebo, paclitaxel and carboplatin in patients affected by advanced or recurrent endometrial cancer .
    Internationale Studie die eine Chemotherapie mit der Kombination Paclitaxel und Carboplatin +/- Atezolizumab bei Frauen mit fortgeschrittenem oder rezidivierendem Endometriumkarzinom vergleicht.
    A.3.2Name or abbreviated title of the trial where available
    AtTEnd
    A.4.1Sponsor's protocol code numberIRFMN-EN-7556
    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 SponsorIRCCS - Istituto di Ricerche Farmacologiche Mario Negri
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationIRCCS Istituto di Ricerche Farmacologiche Mario Negri
    B.5.2Functional name of contact pointElena Biagioli
    B.5.3 Address:
    B.5.3.1Street AddressVia Mario Negri 2
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.6E-mailattend@marionegri.it
    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 LIMITED
    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.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed, histologically-confirmed stage III-IV endometrial carcinoma/carcinosarcoma with residual disease after
    surgery, either measurable or evaluable, and naïve to first line systemic anti-cancer treatment. Recurrent endometrial cancer
    patients if not yet treated for recurrent disease.
    E.1.1.1Medical condition in easily understood language
    Advanced or recurrent endometrial cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014772
    E.1.2Term Endometrioid adenocarcinoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014776
    E.1.2Term Endometrioid adenocarcinoma stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014777
    E.1.2Term Endometrioid adenocarcinoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 in terms of PFS of first-line atezolizumab versus placebo in combination with carboplatin and paclitaxel in patients with MSI advanced stage III/IV or recurrent endometrial cancer.
    To evaluate the efficacy in terms of PFS of first-line atezolizumab versus placebo in combination with carboplatin and paclitaxel in patients with advanced stage III/IV or recurrent endometrial cancer.
    To evaluate the efficacy in terms of OS of first-line atezolizumab versus placebo in combination with carboplatin and paclitaxel in patients with advanced stage III/IV or recurrent endometrial cancer.
    E.2.2Secondary objectives of the trial
    1. To determine the efficacy in terms of ORR, PFS, PFS2 and OS of atezolizumab compared to placebo in PD-L1-ve and PD-L1+ve subgroups.
    2. To determine the efficacy in terms of ORR, PFS, PFS2 and OS of atezolizumab compared to placebo in subgroups according to MS status.
    3. To assess biomarkers that are outcome-independent of treatment (i.e., prognostic biomarkers) and biomarkers of response to atezolizumab (i.e., predictive biomarkers) such as pharmacodynamic exploratory biomarkers and their association with disease status and/or response to study drug.
    4. To evaluate other exploratory biomarkers exploiting liquid biopsies (e.g. circulating tumour DNA [ct-DNA]) for longitudinal monitoring of dynamic biological features of the tumor.
    5. To evaluate the relation between ADAs and PK, toxicity and efficacy of
    atezolizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I-1. Newly diagnosed, histologically-confirmed with residual disease after surgery either measurable or evaluable, or inoperable stage III-IV endometrial carcinoma/carcinosarcoma, after diagnostic biopsy, and naïve to first line systemic anti-cancer treatment. Recurrent endometrial cancer patients if not yet treated for recurrent disease. Hormonal treatment (including but
    not limited to progestins, tamoxifen, luteinizing hormone-releasing hormone
    agonists, aromatase inhibitors) without chemotherapy is allowed.
    I-2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    I-3. Age ≥ 18 years
    I-4. In recurrent patients, only one prior line of systemic platinum-based regimen is permitted if the platinum-free interval ≥ 6 months. Such prior line is the up-front/adjuvant treatment which can be concurrent chemoradiation or concurrent chemoradiation followed by chemotherapy or only chemotherapy.
    I-5. Patients with history of primary breast cancer may be eligible provided they completed their definitive anticancer treatment more than 3 years ago and they remain breast cancer disease free prior to start of study treatment.
    I-6. Previous pelvic and outside pelvis radiation is allowed, except for whole abdominal radiotherapy, if completed more than 6 weeks ago.
    I-7. Capability to give signed informed consent and ability to comply with treatment and follow-up. All patients must sign informed consent form prior their participation in the study.
    I-8. Representative FFPE tumor sample or, only if unfeasible, at least 20 unstained slides from initial surgery or from diagnostic biopsy, in case surgery was not performed, available and sent to central laboratory for Micro Satellite (MS) determination prior to randomization.
    I-9. Patients must have normal organ and bone marrow function :
    a. Haemoglobin ≥ 10.0 g/dL.
    b. Absolute neutrophil count (ANC) ≥ 2.0 x 109/L.
    c. Platelet count ≥ 100 x 109/L.
    d. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
    e. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
    f. Serum creatinine ≤ 1.5 x institutional ULN
    g. Creatinine clearance ≥ 30 mL/min
    E.4Principal exclusion criteria
    E-1.Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ
    cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast. Patients with a history of localized malignancy diagnosed over 5
    years ago may be eligible provided they completed their adjuvant systemic therapy prior to randomization and that the patient
    remains free of recurrent or metastatic disease.
    E-2.Patients with uterine leiomyosarcoma.
    E-3.Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of
    any major surgery.
    E-4.Previous allogeneic bone marrow transplant or previous solid organ transplantation.
    E-5.Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
    E-6.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD1, or anti−PDL1 therapeutic antibodies
    or anti-CTLA4 .
    E-7.Treatment with systemic immunostimulatory agents.
    E-8. Treatment with systemic corticosteroids or other systemic immunosuppressive medications.
    E-9.History of autoimmune disease
    E-10.Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus
    (HIV).
    E-11.Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or
    hepatitis C .
    E-12.Evidence of active tuberculosis
    E-13.Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
    E-14.Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (example approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza vaccine. The use of yellow fever vaccines is contraindicated.
    E-15.Clinically significant (e.g. active) cardiovascular disease, including:
    a.Myocardial infarction or unstable angina within ≤ 6 months of randomization,
    b.New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
    c.Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible),
    d.Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or
    revision)
    E-16.Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT
    syndrome.
    E-17.History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks
    prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in
    any case of suspected central nervous system (CNS) involvement .
    E-18.History or evidence upon neurological examination of central nervous system (CNS) disease, unless asymptomatic and
    adequately treated with standard medical therapy.
    E-19.Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications. Any known psychiatric or substance abuse disorders that would interfere with cooperation and fulfilment of trial requirements.
    E-20. Women of childbearing potential (<2 years after last menstruation) not willing to use highly-effective means of contraception (which include combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) for the duration of treatment and up to the end of the relevant systemic exposure to the study drugs.
    E-21.Pregnant or lactating women.
    E-22.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion
    proteins.
    E-23.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the
    atezolizumab formulation.
    E-24.Known hypersensitivity reaction or allergy to drugs chemically related to carboplatin, paclitaxel, or their excipients that
    contraindicates the subject’s participation.
    E.5 End points
    E.5.1Primary end point(s)
    The study has two coprimary endpoints: OS
    and PFS.
    PFS is defined as the time from randomization to the date of first progression or death from any cause, whichever comes first.
    Progression will be established as the radiological disease progression according to RECIST 1.1 or death from any cause, whichever
    occurs first.
    OS is defined as the time from randomization until the date of death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments should be performed every 9 weeks during the chemotherapy treatment then every 12 weeks
    during the maintenance treatment (atezolizumab or placebo) for the first year from randomization. After the first year the
    assessment during the maintenance phase should be performed every 6 months until progression. Survival data will be collected
    up to the time of the final analysis.
    E.5.2Secondary end point(s)
    Objective Response Rate (ORR), defined
    as the percentage of patients with an objective response as determined by RECIST 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor assessments should be performed every 9 weeks during the chemotherapy treatment then every 12 weeks
    during the maintenance treatment (atezolizumab or placebo) for the first year from randomization. After the first year the
    assessment during the maintenance phase should be performed every 6 months until progression.
    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 Yes
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    New Zealand
    Switzerland
    Taiwan
    Australia
    Japan
    Korea, Republic of
    United Kingdom
    Austria
    Germany
    Italy
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 470
    F.4.2.2In the whole clinical trial 550
    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)
    NA
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SAKK
    G.4.3.4Network Country Switzerland
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation A-AGO Austria
    G.4.3.4Network Country Austria
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation AGO Research GmbH
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation GEICO - Spain
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation NCRI - UK
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Japanese Gynecologic Oncology Group (JGOG)
    G.4.3.4Network Country Japan
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Australia New Zealand Gynaecological Oncology Group (ANZGOG)
    G.4.3.4Network Country Australia
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation KGOG - Korea
    G.4.3.4Network Country Korea, Republic of
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation TGOG - Taiwan
    G.4.3.4Network Country Taiwan
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-16
    P. End of Trial
    P.End of Trial StatusOngoing
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA