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    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   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:2015-000269-30
    Sponsor's Protocol Code Number:MO29518
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-000269-30
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICOHORT, PHASE II STUDY OF MPDL3280A IN ADVANCED SOLID TUMORS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, multicohort, phase II study of MPDL3280A in advanced solid tumors
    A.3.2Name or abbreviated title of the trial where available
    Basket
    A.4.1Sponsor's protocol code numberMO29518
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisationGenentech Inc. c/o F. Hoffmann La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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 nameMPDL3280A -RO5541267-F03-01
    D.3.4Pharmaceutical form 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 INNnot yet defined
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients affected by solid tumors other than hematologic malignancies, non small cell lung cancer , triple-negative breast cancer, urothelial bladder cancer, renal cell carcinoma, melanoma, and glioblastoma that are advanced and have progressed following at least one line of prior systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator.
    E.1.1.1Medical condition in easily understood language
    Study for evaluation of activity of MPDL3280A in different types of tumors
    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
    The main objective is to evaluate the percentage of patients that do not experience progression during the first 18 weeks of treatment with MPDL3280A in patients affected by advanced solid tumors.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the percentage of patients that do not progress during the first 24 weeks of treatment with MPDL3280A, the percentage of patients that achieve a response, the best response achieved, the duration of response and the progression free survival; these variables will be evaluated according to RECIST criteria v1.1. and according to modified RECIST criteria. Moreover OS will be evaluated as secondary endpoint.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Ability to comply with protocol
    2.Male or female, 18 years of age or older
    3.Histologically- or cytologically-documented solid tumors that are advanced and have progressed following at least one line of prior systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator
    4.Representative formalin-fixed paraffin-embedded tumor specimens in paraffin blocks or, in exceptional cases, 15 unstained slides, with an associated pathology report, for central testing. Detection of tumor in the provided block needs to be confirmed by the central pathology laboratory prior to study enrollment. Patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with the Sponsor
    Only tissue from core needle, punch or excisional biopsy sample collection will be accepted. For core-needle biopsy specimens, at least three cores should be submitted for evaluation. Fine-needle aspiration, brushing, bone tissue, and lavage samples are not acceptable
    Patients who do not have tissue specimens meeting eligibility requirements must undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions
    5.Measurable disease as defined by RECIST, v1.1. (except for prostate cancer and malignant pleural mesothelioma) and disease-specific criteria for patients with prostate cancer (see Appendix 6) and malignant pleural mesothelioma (see Appendix 7)
    6.ECOG Performance Status of 0 or 1
    7.Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1):
    -Absolute neutrophil count (ANC) ≥ 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks before Cycle 1, Day 1)
    -Lymphocyte count ≥ 500/µL
    -White blood cell counts > 2500/μL
    -Platelet count ≥ 100,000/µL (without transfusion within 2 weeks before Cycle 1, Day 1)
    -Hemoglobin ≥ 9.0 g/dL (patients may be transfused or receive erythropoyetic treatment to meet this criterion)
    -Serum bilirubin < 1.5 × upper limit of normal (ULN), with the following exception:
    Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled
    -Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 × ULN, with the following exceptions:
    Patients with liver involvement: AST and/or ALT ≤ 5 × ULN
    Patients with liver or bone metastases: alkaline phosphatase ≤ 5 × ULN
    -Serum creatinine ≤ 1.5 × ULN
    -International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low−molecular weight heparin or warfarin) should be on a stable dose
    8.Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
    9.For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) and to continue its use for 90 days after the last dose of MPDL3280A
    E.4Principal exclusion criteria
    1.Hematologic malignancies, NSCLC, triple-negative breast cancer, urothelial bladder cancer, renal cell carcinoma, melanoma, and glioblastoma
    2.Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative
    3.Uncontrolled tumor-related pain
    4.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    5.Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
    6.Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
    7.Leptomeningeal disease
    8.Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to Cycle 1, Day 1
    9.Any approved anticancer therapy, including chemotherapy, hormonal therapy or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: hormone-replacement therapy or oral contraceptives and palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day. Acute toxicities from previous therapy that have not resolved to Grade ≤ 1, except for alopecia
    10.Pregnant and lactating women
    11.Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
    12.Significant cardiovascular disease, such as New York Heart Association cardiac disease, myocardial infarction within 3 months prior to Cycle 1, Day 1, unstable arrhythmias or unstable angina
    13.Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
    14.Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day. Patients receiving prophylactic antibiotics are eligible
    15.Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
    16.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    17.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the MPDL3280A formulation
    18.History of autoimmune disease. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
    Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
    19.Prior allogeneic bone marrow transplantation or prior solid organ transplantation
    20.History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted
    21.Any other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication
    22.Positive test for HIV
    23.Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
    24.Active tuberculosis
    25.Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
    26.Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
    27.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD1, or anti−PDL1 therapeutic antibodies. Patients who have received prior treatment with anti−CTLA-4 may be enrolled, provided at least 5 half-lives have elapsed from the last dose of anti-CTLA-4 to the first dose of MPDL3280A and there was no history of severe immune-mediated adverse effects from anti−CTLA-4
    28.Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug prior to Cycle 1, Day 1
    29.Treatment with an investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer)
    30.Known tumor PD-L1 expression status from other clinical trials
    31.Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate non-progression rate (NPR) at 18 weeks in patients with advanced solid tumors treated with MPDL3280A, defined as the percentage of patients with complete response (CR) partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST, v1.1) (except for prostate cancer and malignant pleural mesothelioma) and disease-specific criteria for patients with prostate cancer and malignant pleural mesothelioma
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 weeks
    E.5.2Secondary end point(s)
    To evaluate NPR at 24 weeks, overall response rate (ORR), best overall response (BOR), clinical benefit rate (CBR), duration of response (DOR), time to tumor progression (TTP) and progression-free survival (PFS), as assessed by the Investigator using RECIST, v1.1 (except for prostate cancer and malignant pleural mesothelioma) and disease-specific criteria for patients with prostate cancer and malignant pleural mesothelioma
    To evaluate NPR at 18 and 24 weeks, ORR, BOR, CBR, DOR, TTP and PFS, as assessed by the Investigator using modified RECIST
    To evaluate overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    NPR at 24 weeks according to RECIST v1.1
    NPR at 18 and 24 weeks according to modified RECIST
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Brazil
    Canada
    China
    Denmark
    Finland
    France
    Germany
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Switzerland
    Turkey
    United Kingdom
    United States
    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
    The end of study for each cohort will occur when all patients have been followed for survival for a minimum of 24 months after the last patient has been enrolled or until all patients have died, withdrawn consent or are lost to follow up, whichever occurs first.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 225
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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)
    The Sponsor will offer post-trial access to the study drug (MPDL3280A) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product. The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following Web site:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2015-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-15
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