Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 December 2019 |
Main ID: |
EUCTR2014-003231-19-PT |
Date of registration:
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28/01/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A comparative study of MPDL3280A versus chemotherapy in patients with advanced bladder cancer.
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Scientific title:
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A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY |
Date of first enrolment:
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26/01/2015 |
Target sample size:
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931 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003231-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Bosnia and Herzegovina
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Bulgaria
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Canada
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Croatia
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Greece
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Hungary
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Italy
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Latvia
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Lithuania
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Mexico
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Netherlands
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Norway
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Peru
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Poland
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Portugal
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Romania
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Slovakia
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Slovenia
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o F. Hoffmann La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o F. Hoffmann La Roche Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: •Age >/= 18 years
•Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
•Representative tumor specimens as specified by the protocol
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy >/= 12 weeks
•Measurable disease, as defined by RECIST v1.1
•Adequate hematologic and end organ function
•Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 740 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 191
Exclusion criteria: • Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
• Active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
•Leptomeningeal disease
•Malignancies other than UBC 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 outcome or incidental prostate cancer
•Pregnant and lactating women
•History of autoimmune disease
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
•Serum albumin < 2.5 g/dL
•Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis
•Severe infections within 4 weeks prior to Cycle 1, Day 1
•Significant cardiovascular disease
•Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
•Prior allogeneic stem cell or solid organ transplant
•Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
•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 complications
•Prior treatment with CD137 agonists or immune checkpoint blockade
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Advanced tumor and metastastic disease
MedDRA version: 20.0
Level: LLT
Classification code 10046721
Term: Urothelial carcinoma bladder stage III
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: MPDL3280A-RO5541267-F-03 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Atezolizumab Current Sponsor code: RO5541267 Other descriptive name: MPDL3280A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60-
Trade Name: Javlor Product Name: vinflunine Product Code: RO7059926 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: VINFLUNINE CAS Number: 162652-95-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
Trade Name: Docetaxel Product Name: Docetaxel Product Code: RO0647746 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: RO-0647746 Other descriptive name: DOCETAXEL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
Trade Name: Paclitaxel Product Name: paclitaxel Product Code: RO0247546 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
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Primary Outcome(s)
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Main Objective: To evaluate the efficacy of MPDL3280A treatment compared with chemotherapy treatment with respect to OS in patients with locally advanced or metastatic UBC who have progressed during or following a platinum-containing regimen
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Secondary Objective: To evaluate the efficacy of MPDL3280A compared with chemotherapy with respect to anti-tumor effects as measured by ORR per investigator with use of RECIST v1.1 To evaluate the efficacy of MPDL3280A compared with chemotherapy with respect to anti-tumor effects as measured by PFS per investigator with use of RECIST v1.1 To evaluate the efficacy of MPDL3280A compared with chemotherapy with respect to anti-tumor effects as measured by duration of objective response (DOR) per RECIST v1.1
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Timepoint(s) of evaluation of this end point: every 3 months until death, loss to follow-up, or study termination by the Sponsor
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Primary end point(s): OS
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Secondary Outcome(s)
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Secondary end point(s): overall response rate (ORR), progression free survival (PFS), duration of response (DOR)
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Timepoint(s) of evaluation of this end point: Every 9 weeks for 54 weeks and every 12 weeks thereafter until disease progression
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Secondary ID(s)
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GO29294
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2014-003231-19-CZ
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Source(s) of Monetary Support
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F. Hoffmann -La Roche Ltd
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Ethics review
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Status: Approved
Approval date:
Contact:
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