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    The EU Clinical Trials Register currently displays   40657   clinical trials with a EudraCT protocol, of which   6636   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004744-11
    Sponsor's Protocol Code Number:PERFECT
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-004744-11
    A.3Full title of the trial
    PDL-1 targeting in resectable oesophageal cancer: a phase IB feasibility study of Atezolizumab and chemoradiation (PERFECT)
    Haalbaarheidsonderzoek naar de behandeling van preoperatieve chemoradiotherapie en atezolizumab gevolgd door operatie bij patiënten met slokdarmkanker
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PDL-1 targeting in resectable oesophageal cancer: a phase IB feasibility study of Atezolizumab and chemoradiation (PERFECT)
    Haalbaarheidsonderzoek naar de behandeling van preoperatieve chemoradiotherapie en atezolizumab gevolgd door operatie bij patiënten met slokdarmkanker
    A.3.2Name or abbreviated title of the trial where available
    PERFECT
    PERFECT
    A.4.1Sponsor's protocol code numberPERFECT
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportUniversity of Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointLaurien Verkleij
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialmedonc@amc.uva.nl
    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 holderFDA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameTecentriq
    D.3.4Pharmaceutical form Concentrate and solvent 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.3.9.3Other descriptive nameTecentriq
    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 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
    oesophageal cancer
    slokdarmkanker
    E.1.1.1Medical condition in easily understood language
    oesophageal cancer
    slokdarmkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Possibly, outcomes of treatment can be further improved by adding atezolizumab to neoadjuvant chemoradiation. As a first step we aim to know whether the addition of atezolizumab feasible. That is, we want to know how the treatment is tolerated and whether the treatment can be given as scheduled.
    Mogelijk kunnen de uitkomsten van de behandeling verder verbeterd worden door voorafgaand aan de operatie een nieuw middel – atezolizumab - aan de behandeling toe te voegen. Als eerste stap in het onderzoek hiernaar willen we weten of de toevoeging van atezolizumab aan de behandeling haalbaar is. Dat wil zeggen: we willen weten hoe de behandeling wordt verdragen en of de behandeling volgens planning kan worden gegeven.
    E.2.2Secondary objectives of the trial
    Secondary endpoints are:
    • Incidence and severity of toxicity defined according to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria.
    • Percentage completion of chemotherapy and radiation treatment
    • Percentage withdrawal rate from surgery
    • Incidence and severity of post-operative complications according to the Dindo classification.
    • Pathological response according to the Mandard criteria.
    • R0 resection rate.
    • Progression free survival
    • Overall survival

    Exploratory endpoints are:
    • Potential biomarker development based on assessment of tumour biopsies, faeces and blood samples and the proposed mechanism of action of study drugs.
    Secundaire eindpunten zijn:
    • De incidentie en ernst van de toxiciteit gedefinieerd volgens CTCAE v4.03 en Radiation Oncology Group (RTOG) criteria.
    • Percentage voltooiing van chemotherapie en bestraling
    • Percentage terugtrekking een operatie
    • De incidentie en ernst van postoperatieve complicaties volgens de Dindo classificatie.
    • Pathologische reactie volgens de Mandard criteria.
    • Percentage R0 resectie.
    • Progressievrije overleving
    • Algemene overleving

    Verkennende eindpunten zijn:
    • Potentiële biomarker ontwikkeling op basis van de beoordeling van de tumor biopten, uitwerpselen en bloedmonsters en het voorgestelde werkingsmechanisme van de studie medicijnen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically proven adenocarcinoma of the esophagus or gastro esophageal junc
    2. The tumor is surgically resectable
    3. Patient is fit for surgery
    1. Histologische bewezen adenocarcinoom van de slokdarm of slokdarm-maag-overgang
    2. De tumor is chirurgisch te verwijderen.
    3. De patiënt is fit genoeg om een operatie te ondergaan.
    E.4Principal exclusion criteria
    Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer
    Een andere maligniteit die interfereert met de prognose van slokdarmkanker
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is feasibility defined as percentage completion of treatment with atezolizumab. Patients that do not complete treatment with atezolizumab for reasons other than toxicity will be replaced and not included in the analysis of the primary end point
    Het primaire eindpunt is haalbaarheid gedefinieerd als percentage voltooiing van de behandeling met atezolizumab. Patiënten die de behandeling met atezolizumab niet afmaken voor andere redenen dan toxiciteit, worden vervangen en niet opgenomen in de analyse van het primaire eindpunt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At surgery
    Bij de operatie
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    • Incidence and severity of toxicity defined according to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria.
    • Percentage completion of chemotherapy and radiation treatment
    • Percentage withdrawal rate from surgery
    • Incidence and severity of post-operative complications according to the Dindo classification.
    • Pathological response according to the Mandard criteria.
    • R0 resection rate.
    • Progression free survival
    • Overall survival

    Exploratory endpoints are:
    • Potential biomarker development based on assessment of tumour biopsies, faeces and blood samples and the proposed mechanism of action of study drugs.
    Secundaire eindpunten zijn:
    • De incidentie en ernst van de toxiciteit gedefinieerd volgens CTCAE v4.03 en Radiation Oncology Group (RTOG) criteria.
    • Percentage voltooiing van chemotherapie en bestraling
    • Percentage terugtrekking een operatie
    • De incidentie en ernst van postoperatieve complicaties volgens de Dindo classificatie.
    • Pathologische reactie volgens de Mandard criteria.
    • Percentage R0 resectie.
    • Progressievrije overleving
    • Algemene overleving

    Verkennende eindpunten zijn:
    • Potentiële biomarker ontwikkeling op basis van de beoordeling van de tumor biopten, uitwerpselen en bloedmonsters en het voorgestelde werkingsmechanisme van de studie medicijnen
    E.5.2.1Timepoint(s) of evaluation of this end point
    At resection and during follow-up
    Bij de operatie en gedurende follow-up.
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    last visit of the last subject
    Laatste bezoek van de laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    None
    Geen
    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 Decision2017-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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