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    Summary
    EudraCT Number:2018-001807-35
    Sponsor's Protocol Code Number:GETUG-AFU35UC-0160-1715
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-001807-35
    A.3Full title of the trial
    Phase II study of maintenance anti-PD-L1 treatment with atezolizumab after chemo-radiotherapy for muscle-infiltrating bladder cancer patients not eligible for radical cystectomy: Bladder Sparing
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.3.2Name or abbreviated title of the trial where available
    Bladder Sparing
    A.4.1Sponsor's protocol code numberGETUG-AFU35UC-0160-1715
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportLaboratoire ROCHE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointProject Manager, Sandra Pelissier
    B.5.3 Address:
    B.5.3.1Street Address101, rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number331 44 23 55 68
    B.5.5Fax number33185 34 33 79
    B.5.6E-mails-pelissier@unicancer.fr
    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 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.3.2Product code RO5541267
    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.3.9.3Other descriptive nameMPDL3280A
    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 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 older than ≥18 years, muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient’s refusal.
    E.1.1.1Medical condition in easily understood language
    Local bladder cancer
    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 primary objective of this study is to evaluate the efficacy of a maintenance therapy with atezolizumab, an anti-PD-L1, after adjuvant chemo-radiotherapy for the treatment of patients with muscle-invasive bladder cancer not eligible for radical cystectomy, in terms of disease-free survival (DFS) assessed at 2 years.
    E.2.2Secondary objectives of the trial
    •To evaluate local control at 2 and 5 years.
    •To evaluate disease-free survival (DFS) at 5 years.
    •To evaluate overall survival (OS) at 2 and 5 years.
    •To evaluate the tolerance and safety of the treatment strategy.
    •To evaluate patients’ quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biological studies are necessary to increase the knowledge of diseases, which may allow the development of new and more effective treatments. These studies use human biological samples (blood and tumour samples) than are collected from patients either while they receive medical care (examination, surgery) or specifically for the research purpose.
    E.3Principal inclusion criteria
    SELECTION PHASE
    1 Muscle-invasive bladder cancer (MIBC) pT2-T3 histologically confirmed:
    •Urothelial and squamous cell histological types are allowed.
    •De novo MIBC or after a history of non-muscle-invasive bladder cancer.
    •In case of extensive or multifocal bladder carcinoma in situ (CIS), cystectomy is the treatment of choice. However, if cystectomy is impossible, these patients are eligible if chemo-radiotherapy is planned.
    2.Complete transurethral resection of bladder tumour (TURBT), either:
    within 6 weeks of selection if no chemotherapy was administered,
    or
    before starting chemotherapy.
    3.Patients for which chemo-radiotherapy is planned
    4.No major pelvic involvement: pelvic nodes ≤15 mm on CT scan.
    5.No distant metastasis.
    6.Patient unfit for radical cystectomy because of age, comorbidities, or patient’s refusal.
    7.Patients ≥18 years old
    8.ECOG performance status ≤2.
    9 Life expectancy ≥12 months.
    10 Haematological and biological parameters:
    •White blood cell count ≥4000/mm3
    •Platelet count ≥100000 cells/mm3
    •Haemoglobin level ≥9 g/dL or corrected after transfusion
    •A glomerular filtration rate ≥25 mL/min.
    •Adequate renal function: clearance >50 mL/min (MDRD).
    •Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x ULN, or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.
    11.Patients of childbearing potential who agree to use a medically acceptable method of contraception during the study and for 120 days after the last study treatment. Women must have a negative urine or serum pregnancy test before receiving the study treatment and within 14 days prior to selection.
    12.Patients having provided written informed consent prior to any study-related procedures.
    13.Patients affiliated to the social security scheme.
    14.Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
    15.Patient consents to the use of their collected tumour specimen, as well as, blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and protein-based biomarker detection.I

    INCLUSION PHASE
    1.Patients who have received standard (chemo)-radiotherapy ≥60Gy or equivalent on the bladder according to the local practice.
    2.The first administration of atezolizumab must be performed 30 (+/-5) days after the last session of RT.
    3.ECOG performance status ≤2.
    4.Haematological and biological parameters:
    •White blood cell count ≥4000/mm3
    •Platelet count ≥100000 cells/mm3
    •Haemoglobin level ≥9 g/dL or corrected after transfusion
    •A glomerular filtration rate ≥25 mL/min
    •Adequate renal function: clearance >50 mL/min (MDRD)
    •Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x ULN, or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.
    5.Patients of childbearing potential who agree to use a medically acceptable method of contraception during the study and for 120 days after the last study treatment. Women must have a negative urine or serum pregnancy test before receiving the study treatment and within 14 days prior to inclusion.
    6.Patients having provided written informed consent prior to any study-related procedures.
    7.Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
    8.Patient consents to the use of their collected tumour specimen, as well as, blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and protein-based biomarker detection.
    E.4Principal exclusion criteria
    SELECTION PHASE
    Patients are not eligible if they comply with any of the following criteria:
    1.Prior pelvic irradiation.
    2.MIBC histology other than urothelial or squamous cell carcinomas (e.g., adenocarcinomas, micropapillary, sarcomas, or small cell histological types).
    3.History of neoplastic disease, during the 3 years before selection, except completely resected cutaneous basal-cell carcinomas, carcinoma in-situ or localised prostate cancer without biochemical recurrence following definitive treatment.
    4.Prior treatment with CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies.
    5.Contraindications for pelvic radiotherapy (e.g., inflammatory bowel disease).
    6.History of immunodeficiency, including HIV infection, or systemic steroid therapy for any other disease.
    7.A history of active autoimmune disease, except autoimmune-related hypothyroidism and type I diabetes mellitus (see appendix 5).
    8.History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins.
    9.Known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation.
    10.Prior allogeneic stem cell or solid organ transplant.
    11.Patients with the following severe acute co-morbidity are not eligible:
    •Unstable angina or congestive heart failure that required hospitalisation in the 6 months before selection.
    •Transmural myocardial infarction in the 6 months prior to selection.
    •Acute bacterial or fungal infection requiring intravenous antibiotics at selection.
    •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalisation or precluding study therapy at the time of selection.
    •Severe hepatic disease: Child-Pugh Class B or C.
    12.Patients with any other disease or illness which requires hospitalisation or is incompatible with the study treatment are not eligible.
    13.Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study.
    14.Patients enrolled in another therapeutic study within 30 days of selection.
    15.Pregnant or breast feeding women.
    16.Person deprived of their liberty or under protective custody or guardianship.

    INCLUSION PHASE
    The same non-inclusion criteria of selection phase have to be respected.
    E.5 End points
    E.5.1Primary end point(s)
    Disease-free survival (DFS) will be assessed at 2 years. DFS is defined as the delay between date of inclusion and tumour relapse (local, regional, or distant) or death from any cause, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    E.5.2Secondary end point(s)
    •Local control rate will be evaluated by cystoscopy at 2 and 5 years. The presence of non-muscle-invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour.
    •Disease-free survival (DFS) will be assessed at 5 years. DFS is defined as the delay between date of inclusion and tumour relapse (local, regional, or distant) or death from any cause, whichever occurs first.
    •Overall Survival (OS) which will be assessed at 2 and 5 years. OS is defined as the delay between the date of inclusion and the date of death, from any cause.
    •The tolerance and safety will be evaluated by toxicity (acute [<6 months after the start of atezolizumab] and late [≥6 months after the start of atezolizumab]), assessed using the NCI CTCAE v5.0 (see Appendix 2). The tolerance will be evaluated up until 5 years at 2 years and 5 years.
    •Quality of life (QoL) will be assessed by the:
    EORTC QLQ-C30 (see Appendix 3)
    The EORTC QLQ-C30 is composed of five functional scales, three symptom scales, a global health status/QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high score represents a higher response level. Scores will be analysed following the EORTC QLQ-C30 Scoring Manual [1].
    EORTC QLQ-BLM30
    EORTC QLQ-ELD14 - Oncogeriatric evaluations (for patients’ ≥70 years old)
    G8 oncodage (at baseline for patients’ ≥70 years old)
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Local control rate will be evaluated by cystoscopy at 2 and 5 years.
    •Disease-free survival (DFS) will be assessed at 5 years.
    •Overall Survival (OS) which will be assessed at 2 and 5 years.
    •The tolerance will be evaluated up until 5 years at 2 years and 5 years.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biological studies are necessary to increase the knowledge of diseases, which may allow the development of new and more effective treatments. These studies use human biological samples (blood and tumour samples) than are collected from patients either while they receive medical care (examination, surgery) or specifically for the research purpose.
    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.8.2.4Number 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 concerned10
    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
    The end of the study corresponds to the last visit of the last patient (subject) : (LVLS)

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months84
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state77
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    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 Decision2018-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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