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    Summary
    EudraCT Number:2018-003048-22
    Sponsor's Protocol Code Number:Uni-Koeln-3571
    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:2019-04-01
    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 number2018-003048-22
    A.3Full title of the trial
    A phase II trial to evaluate safety and efficacy of adding durvalumab (MEDI4736) to standard neoadjuvant radiochemotherapy and of adjuvant durvalumab +/- tremelimumab in locally advanced esophageal adenocarcinoma and to evaluate biomarkers predictive for response to immune checkpoint inhibition
    Eine Phase II Studie zur Evaluation der Sicherheit und Wirksamkeit von Durvalumab in Kombination mit der standard neoadjuvanten Therapie sowie zur Evaluation von Durvalumab +/- Tremelimumab bei Patienten mit lokal fortgeschrittenem Adenokarzinom des Ösophagus und zusätzlich Evaluation von Biomarkern, die eine Ansprechen auf Immuncheckpoint Inhibitoren vorhersagen könnten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial to evaluate safety and efficacy of adding durvalumab (MEDI4736) to standard neoadjuvant radiochemotherapy and of adjuvant durvalumab +/- tremelimumab in locally advanced esophageal adenocarcinoma and to evaluate biomarkers predictive for response to immune checkpoint inhibition
    Eine Phase II Studie zur Evaluation der Sicherheit und Wirksamkeit von Durvalumab in Kombination mit der standard neoadjuvanten Therapie sowie zur Evaluation von Durvalumab +/- Tremelimumab bei Patienten mit lokal fortgeschrittenem Adenokarzinom des Ösophagus und zusätzlich Evaluation von Biomarkern, die eine Ansprechen auf Immuncheckpoint Inhibitoren vorhersagen könnten
    A.3.2Name or abbreviated title of the trial where available
    RICE: Radio-Immuno-Chemotherapy for Cancer of the Esophagus
    RICE: Radio-Immun-Chemotherapie bei lokal fortgeschrittenem Adenokarzinom des Ösophagus
    A.4.1Sponsor's protocol code numberUni-Koeln-3571
    A.5.4Other Identifiers
    Name:Deutsches Register Klinische Studien Number:DRKS00015218
    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 SponsorUniversität zu Köln
    B.1.3.4CountryGermany
    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 supportAstraZeneca Ab
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Köln
    B.5.2Functional name of contact pointStudienzentrum Klinik I
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Straße 62
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number+492214789653
    B.5.5Fax number+492214781486347
    B.5.6E-mailflorian.gerich1@uk-koeln.de
    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 Imfinzi®
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDurvalumab
    D.3.4Pharmaceutical form Solution for injection
    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 INNDURVALUMAB
    D.3.9.1CAS number 1428935-60-7
    D.3.9.3Other descriptive nameImfinzi
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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: 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 No
    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 nameTremelimumab
    D.3.4Pharmaceutical form Solution for injection
    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 INNTremelimumab
    D.3.9.1CAS number 745013-59-6
    D.3.9.3Other descriptive nameTREMELIMUMAB
    D.3.9.4EV Substance CodeSUB37101
    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) Yes
    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
    locally advanced esophageal adenocarcinoma
    lokal fortgeschrittenes Adenokarzinom des Ösophagus
    E.1.1.1Medical condition in easily understood language
    cancer of the esophagus
    lokal fortgeschrittenes Adenokarzinom der Speiseröhre
    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 10001173
    E.1.2Term Adenocarcinoma of esophagus
    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 efficacy and safety of the IMP and to evaluate biomarkers predictive for response to immune checkpoint inhibition
    E.2.2Secondary objectives of the trial
    - To determine the Best Objective Response (BOR)

    - To determine PFS, DFS and OS in durvalumab vs. durvalumab + tremelimumab adjuvant treatment

    - Esophageal cancer related Quality of Life (FACT-E)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    written informed consent
    - Histologically confirmed, resectable adenocarcinoma of the esophagus (uT2, uN+, cM0 or uT3, cNx, cM0)
    - No preceding cytotoxic or targeted therapy
    - No prior partial or complete tumour resection
    - Male or female patients ≥ 18 years of age at time of study entry
    - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
    - Study participants must be willing to undergo at least 2 biopsies (baseline, after neoadjuvant treatment)
    - Life expectancy of ≥ 12 months
    - Body weight > 30kg
    E.4Principal exclusion criteria
    - Study participants with squamous cell carcinoma of the oesophagus
    - Prior treatment with chemotherapy, targeted therapy or radiotherapy for treatment of advanced disease
    - Patients are excluded if they are not resectable because of tumor infiltrating any other organs (cM1), except the stomach, with risk for R1 or R2 resection or if they are not resectable in case of other serious or uncontrolled medical disease.
    - Patients with tumour stadium less than uT3 or confirmed metastatic diseases
    - Any other serious or uncontrolled medical disorder, active infections, physical exam findings, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a study participant’s ability to comply with the study requirements, substantially increase risk to the study participant, or impact the interpretability or study results
    - Presence or history of any other primary malignancy other than adenocarcinoma of the esophagus within 5 years prior to enrolment into the trial, except for adequately treated basal or squamous cell carcinoma of the skin or any adequately treated in situ carcinoma
    - Pregnant or breastfeeding females
    - Patients has known current symptomatic congestive heart failure (NYHA III and IV), unstable angina pectoris, or cardiac arrhythmia
    E.5 End points
    E.5.1Primary end point(s)
    To assess the rate of complete pathological response. When durvalumab is added to CROSS (carboplatin/paclitaxel + 41,4Gy RTx) in the neoadjuvant setting and PFS in the adjuvant therapy/maintenance with durvalumab after surgery.

    The primary endpoint for safety is incidence, severity and grading of treatment emergent AEs and SAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Direct after surgery
    E.5.2Secondary end point(s)
    1. Response to neoadjuvant treatment (CR, PR, SD, PD) as defined by RECIST 1.1. and iRECIST criteria
    2. PFS and OS in durvalumab vs. durvalumab+tremelimumab adjuvant treatment
    3. Oesophageal cancer related Quality of Life (FACT-E)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Weeks 10 to 11, that means one to three weeks before surgery
    2. Until disease progression (PFS) and/or until 12 months after last administering IMP
    3. From screening until visit 20
    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 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 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 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) 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 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
    LPLV (last patient last visit)
    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 months6
    E.8.9.1In the Member State concerned 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state56
    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)
    After last dose of study medication without any disease progression there will be a 12 months follow-up for study participants.
    Subsequently there will be a survival-follow-up for additional 12 months. During the additional time all patients have a follow-up visit planned for every 3 months.

    If any patient drops out during the trial due to disease progression or any other reason as defined in the exclusion criteria they will receive a standard treatment
    Nach der letzten Gabe der Studienmediaktion und keinem Vorliegen eines Krankheitsprogresses folgt für die Patienten ein 12-monatiges Follow-up.
    Im Anschluss da dieses folgt ein Survival-Follow-Up für weitere 12 Monate, bei dem sich die Patienten alle drei Monate vorstellen sollen.

    Sollte ein Patient auf Grund eines Krankheitsprogresses oder anderen, in den Ausschlusskriterien definierten, Gründen aus der Studie ausscheiden, wird er eine Standardtherapie erhalten.
    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 Centre for Integrated Oncology (CIO Cologne Bonn)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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