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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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).

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    Summary
    EudraCT Number:2018-000257-45
    Sponsor's Protocol Code Number:MO40094
    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:2021-03-18
    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 number2018-000257-45
    A.3Full title of the trial
    A phase Ib/II single-arm study evaluating the safety and efficacy of
    combined immunotherapy with mFOLFOX6, bevacizumab and atezolizumab
    in advanced-stage biliary cancer
    Eine einarmige Phase Ib/II Studie zur Untersuchung der Sicherheit und Wirksamkeit einer kombinierten Immuntherapie mit mFOLFOX6, Bevacizumab und Atezolizumab bei fortgeschrittenem Gallengangskarzinom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase Ib/II single-arm study evaluating the safety and efficacy of
    combined immunotherapy with mFOLFOX6, bevacizumab and atezolizumab
    in advanced-stage biliary cancer
    Eine einarmige Phase Ib/II Studie zur Untersuchung der Sicherheit und Wirksamkeit einer kombinierten Immuntherapie mit mFOLFOX6, Bevacizumab und Atezolizumab bei fortgeschrittenem Gallengangskarzinom
    A.3.2Name or abbreviated title of the trial where available
    COMBATBIL
    A.4.1Sponsor's protocol code numberMO40094
    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 Hospital Essen
    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 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 organisationUniversitätsmedizin Essen - Studienzentrum GmbH
    B.5.2Functional name of contact pointStudy Coordination
    B.5.3 Address:
    B.5.3.1Street AddressHufelandstraße 55
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45147
    B.5.3.4CountryGermany
    B.5.4Telephone number+4920172377412
    B.5.5Fax number+49 2017239477412
    B.5.6E-mailume-studienzentrum@uk-essen.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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderHoffmann-La Roche Ltd
    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 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.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderHoffmann-La Roche Ltd
    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 nameBevacizumab
    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 INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    advanced biliary tract cancer (BTC)
    E.1.1.1Medical condition in easily understood language
    advanced biliary tract cancer (BTC)
    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 10008593
    E.1.2Term Cholangiocarcinoma
    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 of the combination of mFOLFOX6, bevacizumab
    and atezolizumab in advanced-stage BTC measured by radiographic
    tumor response
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of the combination of mFOLFOX6,
    bevacizumab and atezolizumab in BTC by measuring disease control,
    progression-free survival (PFS) and overall survival (OS)
    • To evaluate safety and tolerability of the combination of mFOLFOX6,
    bevacizumab and atezolizumab in patients with BTC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must fulfill all of the following criteria for study entry:
    1. Signed informed consent form
    2. Age ≥ 18 years by the time of inclusion in the study
    3. Ability to comply with the study protocol, in the investigator’s judgment
    4. Histologically confirmed advanced BTC
    5. Patient must have received at least one prior line of systemic therapy in advanced-stage BTC
    6. Adjuvant or neoadjuvant chemotherapy is allowed, provided it is completed at least 6 months before start of study treatment.
    7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 (see Appendix VI)
    8. Life expectancy > 12 weeks
    9. Measurable disease, according to RECIST v1.1. Lesions intended to be biopsied should not be defined as target lesions.
    10. Tumor must be accessible for biopsies and patient willing to provide tissue from a newly obtained biopsy of a tumor lesion. In exceptional cases, if a pre-treatment biopsy is not deemed feasible by the investigator, archival biopsies can be used after Sponsor approval has been obtained, as long as they were collected no more than 6 months prior to enrollment.
    11. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
     WBC ≥ 2.5 x 109/L
     ANC ≥ 1.5 x 109/L without granulocyte colony-stimulating factor support
     Platelet count ≥ 100 x 109/L without transfusion
     Hemoglobin ≥ 9 g/dL. Patients may be transfused to meet this criterion.
     Albumin ≥ 2.5 g/dL
     Serum total bilirubin ≤ 3 ULN; patients with known Gilbert’s disease may have a total bilirubin ≤ 3.0 x ULN
     Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and PTT < 1.5 ULN . The use of full dose oral or parenteral anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least three weeks at the time of initiation of study treatment. Prophylactic use of anticoagulants is allowed.
     Amylase and lipase ≤ 1.5 x ULN
     AST, ALT and ALP ≤ 3 x ULN with the following exceptions:
    o Patients with documented liver metastases: AST and/or ALT ≤ 5 x ULN
    o Patients with documented liver or bone metastases: ALP ≤ 5 x ULN
     Serum creatinine ≤ 1.5  ULN or Creatinine clearance ≥ 30 mL/min (calculated using the Cockcroft-Gault formula)
    12. For women of childbearing potential: Negative serum pregnancy test within 21 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of ≤ 1% per year during the treatment period and for at least 180 days after the last study treatment.
     A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
     Examples of contraceptive methods with a failure rate of ≤ 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices.
     The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
    13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
     With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 180 days after the last dose of study treatment. Men must refrain from donating sperm during this same period.
     The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
    E.4Principal exclusion criteria
    1. Malignancies other than BTC within 3 years prior to C1D1 with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year overall survival > 90%) treated with expected curative outcome
    2. Patients with known microsatellite instability high (MSI-H) status. Patients with unknown MSI status are eligible and the MSI status will be analyzed retrospectively. Patients who are then determined to be MSI high will be allowed to continue the study treatment, but will be replaced by microsatellite-stable (MSS) or MSI-low tumors.
    3. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques must have been completed at least 4 weeks prior to initiation of study treatment.
    4. Radiation therapy within 21 days prior to C1D1 and/or persistence of radiation-related adverse effects
    5. Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past
    6. Spinal cord compression not definitively treated with surgery and/or radiation
    7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    8. Uncontrolled tumor pain.
    9. Treatment with any investigational agent or approved therapy within 14 days or two investigational agent half-lives (whichever is longer) prior to C1D1
    10. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-PD-1 and anti-PD-L1 or VEGF/VEGFR inhibitors
    11. Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5-FU toxicity
    12. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    13. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any components of atezolizumab or bevacizumab formulations
    14. Current or recent (within 10 days of study enrollment) use of acetylsalicylic acid (> 325 mg/day), clopidogrel (> 75 mg/day) or thrombolytic agents for therapeutic purposes
    15. History of clinically significant cardiac or pulmonary dysfunction
    16. History of idiopathic pulmonary fibrosis, organizing pneumonia
    17. Major surgical procedure within 4 weeks prior to C1D1 or anticipation of need for a major surgical procedure during the course of the study
    18. Evidence of tumor invading or abutting major blood vessels
    19. Serious non-healing wound, active ulcer or untreated bone fracture
    20. History of abdominal fistula or gastrointestinal perforation within 6 months prior to C1D1
    21. History of hemoptysis (≥ ½ teaspoon of bright red blood per episode), or any other serious hemorrhage, or at risk of bleeding
    22. INR > 1.5 and aPTT > 1.5 x ULN within 14 daysprior to C1D1 (excluding patients on prophylactic or therapeutic anticoagulation)
    23. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
    24. Proteinuria at screening as demonstrated by urine dipstick ≥ 2+ or 24-hour proteinuria > 1.0 g
    25. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.
    26. Systemic immunostimulatory agents (including, but not limited to, interferons and IL-2) are prohibited within 4 weeks or five half-lives of the drug (whichever is longer) prior to C1D1.
    27. Autoimmune conditions with exceptions
    28. Infectious diseases
     Severe infection within 4 weeks prior to initiation of C1D1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
     Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
     Patients with active hepatitis B
     Patients with past HBV infection or resolved HBV infection are eligible. HBV DNA test must be performed in these patients prior to C1D1.
     Patients with active hepatitis C. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
     Positive HIV test at screening or at any time prior to screening. Patients without a prior positive HIV test result will undergo an HIV test at screening, unless not permitted per local regulations
     Known active tuberculosis
     Patients must not receive any kind of living, attenuated vaccine (e.g., Fluenz® Tetra) within 4 weeks prior to C1D1 or at any time during the study and for at least 5 months after the last dose of study drug.
    29. Pregnant or lactating, or intending to become pregnant during the study or within 5 months after final dose for atezolizumab or 6 months for bevacizumab.
    30. Uncontrolled serious medical or psychiatric illness
    E.5 End points
    E.5.1Primary end point(s)
    ORR defined as the proportion of patients with a complete response (CR)
    or partial
    response (PR), determined by the investigator (INV) following RECIST
    v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR will be assessed after 12 weeks of treatment
    E.5.2Secondary end point(s)
    • Disease control rate (DCR) at weeks 12 and 18
    • Duration of response (DOR)
    • Best objective response rate (BORR)
    • Progression-free survival (PFS)
    • Time to treatment failure (TTF)
    • Best percentage change from baseline in tumor size
    All secondary endpoints above will be based on investigator assessment
    both by INV-RECIST v1.1 and (also ORR) by modified criteria for immunotherapies iRECIST
    • ORR by independent radiological review per RECIST v1.1 and by
    modified criteria for immunotherapies iRECIST
    • Overall survival (OS)
    • Safety: incidence and severity of adverse events (AEs) (with severity
    determined according to NCI CTCAE v5.0), vital signs and clinical
    laboratory test results
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12 and 18 for the Disease control rate (DCR)
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    proof-of-concept study
    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.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    The study will end if either a criterion for futility or efficacy addressed
    in the interim analyses is not fulfilled or if the maximum enrolled
    number of patients has been followed until death, withdrawal of
    consent, lost to follow-up, or the Sponsor decides to end the trial,
    whichever occurs first.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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)
    In absence of unacceptable toxicity, patients who meet criteria for
    disease progression (PD) per RECIST while receiving study treatment can
    continue study treatment if they meet ALL following criteria:
    • Evidence of clinical benefit
    • Absence of symptoms & signs indicating PD
    • Absence of decline in ECOG PS that can be attributed to PD
    • Absence of tumor progression at critical anatomical sites that cannot
    be managed by protocol-allowed medical interventions
    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 Decision2021-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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