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   43851   clinical trials with a EudraCT protocol, of which   7283   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:2018-002227-42
    Sponsor's Protocol Code Number:UCL/17/0192
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-11-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-002227-42
    A.3Full title of the trial
    Avelumab in the frontline treatment of advanced classical Hodgkin lymphoma - a window study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avelumab in the frontline treatment of advanced classical Hodgkin lymphoma - a window study
    A.3.2Name or abbreviated title of the trial where available
    AVENuE
    A.4.1Sponsor's protocol code numberUCL/17/0192
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03617666
    A.5.4Other Identifiers
    Name:Pfizer Reference Number:WI224198
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    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 supportPfizer Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCancer Research UK & UCL Cancer Trials Centre
    B.5.2Functional name of contact pointEmma Barsoum
    B.5.3 Address:
    B.5.3.1Street AddressCR UK & UCL CTC, 90 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076799873
    B.5.5Fax number02076799861
    B.5.6E-mailctc.AVENuE@ucl.ac.uk
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Avelumab
    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 nameAvelumab
    D.3.2Product code MSB0010718C
    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 INNAvelumab
    D.3.9.1CAS number 1537032-82
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced classical Hodgkin lymphoma
    E.1.1.1Medical condition in easily understood language
    Advanced classical Hodgkin lymphoma is a cancer that causes the lymphocytes (a type of white blood cell involved in fighting infections) to grow abnormally.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    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 find out how patients with newly diagnosed untreated Hodgkin lymphoma respond to treatment with 4 doses of avelumab. To also see if standard chemotherapy treatment can be safely given following treatment with avelumab.
    E.2.2Secondary objectives of the trial
    To investigate how many patients are alive and how many have not progressed (overall and progression-free survival) 1 year after they were registered to the trial.

    To investigate what side effects patients experience when treated with avelumab.

    To investigate what side effects patients experience with standard chemotherapy treatment after being treated with avelumab first.

    To find out how many patients respond to treatment after 2 cycles of treatment with ABVD chemotherapy.

    To find out the number of patients who complete standard chemotherapy treatment as planned (i.e. with no delays or reductions in the doses).

    To see if there are any particular features in patient’s blood that can predict how well patients will respond to avelumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged 16-60 (inclusive)
    • Previously untreated classical Hodgkin lymphoma
    • High risk stage II (defined as stage IIB, presence of bulky disease (but see exclusions), 3 or more sites of disease), stage III or IV as assessed by FDG-PET/CT
    • ECOG performance status 0-1
    • Adequate bone marrow function (Hb >80g/l, Platelets >75 x 109/l, neutrophils >1.0 x 109/l)
    • Adequate liver function tests (ALT/AST <2.5 x ULN, total serum bilirubin level <1.5 x ULN)
    • Creatinine clearance >50ml/min calculated by Cockroft-Gault formula
    • Written informed consent
    • Willing to comply with the contraceptive requirements of the trial
    • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    E.4Principal exclusion criteria
    • Nodular lymphocyte predominant Hodgkin lymphoma
    • Compressive symptoms due to disease (which may or may not be bulky). If there is evidence of compression of vital structures radiologically but the patient is asymptomatic, the case must be discussed with the TMG.
    • Requirement for urgent treatment due to life-threatening complications of the disease
    • Women who are pregnant or breastfeeding
    • History of colitis, inflammatory bowel disease or pneumonitis
    • Patients with autoimmune disorders excluding patients with vitiligo, diabetes mellitus type 1, hypo- and hyperthyroidism, coeliac disease not requiring immunosuppressive therapy
    • Immunosuppressive therapy within the last 2 months, apart from inhaled, intranasal, topical corticosteroids or systemic corticosteroids at low doses (≤10mg prednisolone per day or equivalent - see steroid exception below)
    • Prior history of solid organ or allogeneic haematopoietic stem cell transplant
    • Positive serology for hepatitis B or C (unless due to vaccination)
    • Known HIV infection
    • Administration of a live vaccine within 30 days prior to study entry
    • History of allergy to monoclonal antibodies, anaphylaxis or uncontrolled allergy
    • Chemo- or radiotherapy within 15 days of registration. Corticosteroids permitted for disease control but must be weaned down to ≤10mg prednisolone per day or equivalent at least 7 days prior to starting avelumab – steroids may only be started for disease control after the baseline PET-CT
    • Persisting toxicity (of >grade 1) related to prior therapy, however, alopecia, sensory neuropathy Grade <2, or other grade <2 not constituting a safety risk based on investigator’s judgement are acceptable
    • Major surgery within 4 weeks prior to registration
    • Active infection requiring systemic therapy
    • Myocardial infarction, unstable angina, coronary artery bypass graft, cerebrovascular accident or transient ischaemic attack within the past 6 months
    • Non-haematological malignancy within the past 3 years
    • Previously treated haematological malignancy
    • Any uncontrolled medical condition which can impair delivery of planned immunochemotherapy
    • Patient not deemed suitable for ABVD/AVD/escalated-BEACOPP/BEACOPP-14
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (complete metabolic response (CMR) and partial metabolic response (PMR)) after 2 cycles (4 doses) of single agent avelumab treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response assessed by centrally reviewed PET-CT scan after the 4th dose of avelumab.

    The PET-CT scan will be performed between 15-20 days after the 4th dose of avelumab, as per trial requirements on an approved scanner and images sent to the UK PET Core Lab at St Thomas' Hospital (for UK sites) and/or the Australian PET Core Lab at Department of Molecular Imaging and Therapy, Austin Hospital, Heidelberg, Australia (Australian sites) for central review.
    E.5.2Secondary end point(s)
    1) Progression free survival (PFS) and overall survival (OS) of the entire population at 1 year.

    2) Toxicity and safety of avelumab


    3) Toxicity and safety of subsequent ABVD-based chemotherapy

    4) Complete metabolic response (CMR) and Partial Metabolic Response) PMR rates following 2 cycles of ABVD

    5) Proportion of patients successfully completing subsequent planned chemotherapy without delays or dose modifications
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) PFS time will be calculated from the date of registration until the date of progression or death. OS time will be calculated from the date of registration until the date of death.

    2) From the start of avelumab until 30 calendar days post last avelumab treatment administration; late toxicity during follow up will also be reported.

    3) From the start of treatment with ABVD and 30 calendar days post last NIMP administration.

    4) CMR and PMR Response assessed by centrally reviewed PET-CT scan performed 15-20 days after the 4th dose of avelumab.

    5) After completion of all NIMP treatment (AVD/BEACOPP).
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA11
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    E.8.7Trial has a data monitoring committee No
    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
    End of trial will be declared when the last patient has completed 1 year of follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 47
    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)
    Trial treatment with avelumab is of a limited duration (up to 2 cycles) and Pfizer have committed to supply avelumab for the duration of the trial. Therefore AVENuE patients will not require treatment with the study drug beyond the end of the research.

    Patients will receive the local standard of care for their disease as required after the trial ends.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    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-Fri Apr 19 23:18:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA