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    Summary
    EudraCT Number:2018-003902-14
    Sponsor's Protocol Code Number:EORTC-1741-GITCG
    National Competent Authority:Cyprus - MoH-Ph.S
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-07
    Trial results View 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 ConcernedCyprus - MoH-Ph.S
    A.2EudraCT number2018-003902-14
    A.3Full title of the trial
    DKN-01/atezolizumab as second line treatment of biliarY tract cancer and in combiNAtion or not with paclitaxel as second line treatMent of esophagogastrIC cancer: a multi-center Phase II Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of non-operable esophagogastric carcinoma cancer patients or non-operable biliary cancer who progressed/spread/ got worse after first line treatment with a novel combination of DKN-01/Atezolizumab with or without Paclitaxel: a Phase II trial
    A.3.2Name or abbreviated title of the trial where available
    DYNAMIC
    A.4.1Sponsor's protocol code numberEORTC-1741-GITCG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03818997
    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 SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 supportEuropean Organisation for the Research and Treatment of Cancer
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportLeap Therapeutics, Inc
    B.4.2CountryUnited States
    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 organisationEuropean Organisation for the Research and Treatment of Cancer
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street Address83/11 Avenue E. Mounier
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number00327741023
    B.5.5Fax number00327727063
    B.5.6E-mailregulatory@eortc.org
    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 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 nameDKN-01
    D.3.2Product code LY2812176
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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.3.4Pharmaceutical form Concentrate for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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: 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 Paclitaxel (Generic)
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePaclitaxel
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Non-operable biliary tract cancer (BTC) and non-operable esophagogastric cancer (EGC) adenocarcinoma.
    E.1.1.1Medical condition in easily understood language
    Biliary Tract Cancer

    Esophagogastric Cancer
    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 PT
    E.1.2Classification code 10061203
    E.1.2Term Hepatobiliary neoplasm
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10019817
    E.1.2Term Hepatobiliary neoplasms NEC
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10019811
    E.1.2Term Hepatobiliary neoplasms
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10019805
    E.1.2Term Hepatobiliary disorders
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10019814
    E.1.2Term Hepatobiliary neoplasms malignancy unspecified
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10019815
    E.1.2Term Hepatobiliary neoplasms malignant and unspecified
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal cancer
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10062878
    E.1.2Term Gastrooesophageal cancer
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10017812
    E.1.2Term Gastric neoplasms malignant
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10017991
    E.1.2Term Gastrointestinal neoplasms malignant and unspecified
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10017990
    E.1.2Term Malignant and unspecified neoplasms gastrointestinal NEC
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to investigate:
    •whether the combination of atezolizumab and DKN-01 can demonstrate sufficient antitumor activity to justify further investigation as second line treatment in patients with non-operable BTC.
    •whether the combination of atezolizumab, DKN-01 and paclitaxel can improve efficacy compared to historical controls treated with standard of care as second line treatment in patients with non-operable esophagogastric cancer (EGC) adenocarcinoma.
    •whether a combination regimen atezolizumab + DKN-01 without chemotherapy can demonstrate sufficient antitumor activity to justify further investigation as second line treatment in patients with non-operable EGC adenocarcinoma.
    Each primary objective in this study will be evaluated independently. The formal comparison of atezolizumab + DKN-01 with or without chemotherapy in patients with esophagogastric adenocarcinoma is beyond the scope of this phase II trial with limited sample size.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    •to assess the tolerability and safety profile of DKN-01/atezolizumab ± paclitaxel in EGC and of DKN-01/atezolizumab in BTC.
    •to document the long-term outcome of patients with EGC treated with DKN-01/atezolizumab ± paclitaxel and of patients with BTC treated with DKN-01/atezolizumab in terms of Progression free survival (PFS) and Overall survival (OS).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Analysis of changes in immune cells, cytokines, and potential circulating biomarkers during the course of the treatment. Molecular characterization of the tumor and link with response to DKN-01+atezolizumab +/- paclitaxel.
    E.3Principal inclusion criteria
    • Histologically proven diagnosis of metastatic or unresectable intra or extrahepatic cholangiocarcinoma or esophagogastric adenocarcinoma.
    • Measurable disease by CT/MRI (RECIST 1.1) within 28 days of enrollment (BTC)/randomization (EGC)
    • Male and female subjects of age ≥18 years
    • Performance status ECOG 0-1
    • Life expectancy ≥ 4 months in the opinion of the investigator
    • Normal 12-lead ECG (patients with abnormal ECG will be eligible if changes are not considered clinically significant by the local investigator)
    • Adequate hematological function:
    o Hemoglobin ≥ 9 g/dl (prior transfusions are allowed if they have been done ≥ 7 days before testing the Hb)
    o White blood cell (WBC) ≥ 3.0 x 109/L
    o Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    o Platelet count ≥ 75 x 109/L
    • Adequate liver function:
    o Total bilirubin ≤ 1.5 x upper limit of normal (ULN), except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN.
    o ALT, AST & alkaline phosphatase ≤ 3 x ULN; ≤ 5 x ULN in case of liver/bone metastases
    o Serum albumin ≥ 2.5 g/dL
    • Adequate renal function:
    o Estimated glomerular filtration rate (eGFR) according to MDRD (see Appendix G) should be > 50 ml/min
    • Adequate coagulation:
    o International Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants
    • The following local treatment modalities are allowed prior to enrollment/randomization within the rules described (provided there has been a full recovery):
    o Surgery: patients may have undergone a non-curative operation (i.e., R2 resection [with macroscopic residual disease] or palliative bypass surgery only), performed at least 28 days before enrollment/randomization. Patients who have previously undergone curative surgery, must have evidence of non-resectable and measurable disease relapse requiring systemic chemotherapy prior to study entry.
    o Radiotherapy: patients may have received prior radiotherapy (with or without radiosensitising low-dose chemotherapy) for localised disease. However, there must be clear evidence of disease progression post-treatment prior to inclusion in this study. The radiotherapy should have been finished at least 15 days prior to enrollment/randomization.
    o Photodynamic therapy (PDT) for localized disease only with no evidence of metastatic disease - patients may have received prior PDT, provided the patient has fully recovered and at least 28 days have elapsed since the PDT and there is clear evidence of disease progression at the local site or disease or at a new metastatic site.
    o Other previous localised treatments targeting intrahepatic lesions such as selective internal radiation therapy (SIRT) , transarterial chemoembolisation (TACE) and radiofrequency ablation (RFA) are allowed, provided the patient has finished it at least 15 days prior to enrollment/randomization, with full recovery.
    • Asymptomatic subjects with known Central Nervous system (CNS) metastases are eligible, provided that all of the following criteria are met:
    o Measurable disease, per RECIST v1.1, must be present outside the CNS.
    o The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
    o The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
    oIn addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to enrollment /randomization.
    oAny brain metastases must be stable for at least 6 months.
    • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
    • Rash must cover < 10% of body surface area
    • Disease is well controlled at baseline and requires only low-potency
    topical corticosteroids
    Note: see exclusion criteria for acute exacerbations
    •Availability of 1 FFPE block (preferred), or if not available, minimum 15-20 freshly cut (≤ 7 days) unstained slides of tumor tissue (either from current or previous resection/biopsy) for biobanking/translational research. If less tumor tissue available please contact the HQ study team.
    • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment.

    PLEASE REFER TO THE PROTOCOL FOR THE COMPLETE LIST OF INCLUSION CRITERIA
    E.4Principal exclusion criteria
    • Subjects with pleural effusion, pericardial effusion, or ascites with symptoms uncontrolled by medication or who require recurrent drainage procedures (once monthly or more frequently).
    • Leptomeningeal spread of disease.
    • Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to enrollment/randomization.
    • Other concomitant or prior malignancy within the last 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or in-situ carcinoma of the cervix.
    • History of inflammatory bowel disease or any autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, type I diabetes mellitus, vasculitis, or glomerulonephritis.
    • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study.
    • Patients with controlled Type I diabetes mellitus on a stable insulin regimen are eligible.
    • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are not eligible in case of occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or high-potency or oral corticosteroids within the previous 12months.
    • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computerized tomography (CT) scan
    o History of radiation pneumonitis/fibrosis in the radiation field is permitted.
    • Infections:
    o Signs or symptoms of infection or therapeutic use of antibiotics (except prophylactic antibiotics) within 2 weeks prior to enrollment/randomization and severe infections within 4 weeks prior to enrollment/randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
    o Known or current evidence of Human Immunodeficiency Virus (HIV) (test to be performed within 14 days of enrollment/randomization)
    o Active or chronic hepatitis B or hepatitis C
     Patients with past/resolved hepatitis B virus (HBV) infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. HBV Deoxyribonucleic acid (DNA) must be obtained in patients with positive hepatitis B core antibody prior to enrollment/randomization.
     Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
    o Active tuberculosis
    • Conditions leading to immune suppression or stimulation of the immune system, such as:
    o Prior treatment with checkpoint inhibitors
    o Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided at least 5 half-lives (approximately 75 days) have elapsed since the last dose of anti-CTLA-4 and there was no history of severe immune-mediated adverse effects from anti-CTLA-4 (NCI CTCAE 5 Grade 3 or 4)
    o Treatment with systemic immunostimulatory agents (including but not limited to IFN , IL-2) for any reason within 6 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment/randomization.
    o Prior allogeneic stem cell or solid organ transplant.
    • Subjects with a condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of randomization/enrollment
    • Prior treatment with an anti-DKK1 therapy
    • Administration of a live, attenuated vaccine within 30 days prior to the first dose of study medication or anticipation that such a live attenuated vaccine will be required during the study. Any live, attenuated vaccine (e.g. FluMist®) is prohibited while the patient is receiving atezolizumab and for a period of 5 months after discontinuation of atezolizumab. Inactivated influenza vaccines are allowed only during flu season.
    PLEASE REFER TO THE PROTOCOL FOR THE COMPLETE LIST OF EXCLUSION CRITERIA
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is Objective response rate (ORR) (including complete and partial response) according to RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until 2 years after start of study treatment.
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    -Best overall response distribution according to RECIST1.1 and iRECIST
    -Immune objective response rate (iCR+iPR) according to iRECIST
    -Duration of response and stable disease using RECIST 1.1 and iRECIST
    -PFS according to RECIST 1.1 and iRECIST
    -Overall survival (OS)
    -Safety (worst laboratory and clinical AE's grades) per CTCAE 5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until 2 years after start of study treatment
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    BTC cohort: single arm; EGC cohort: randomized open
    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.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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 study occurs when all of the following criteria have been satisfied:
    1. Ninety (90) days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint in all 3 arms as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis.
    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 months3
    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 months3
    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: 104
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 Information not present in EudraCT
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 123
    F.4.2.2In the whole clinical trial 123
    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)
    According to the discretion of the treating physician
    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 Decision2019-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-01-27
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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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