A comparative study of MPDL3280A versus chemotherapy in patients with advanced bladder cancer.

• Register: EUCTR
• Last refreshed on: 4 December 2018
• Main ID: EUCTR2014-003231-19-DK
• Date of registration: 09/02/2015
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A comparative study of MPDL3280A versus chemotherapy in patients with advanced bladder cancer.
• Scientific title: 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: 13/02/2015
• Target sample size: 931
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003231-19
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann La Roche Ltd

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Advanced tumor and metastastic disease
MedDRA version: 20.0 Level: LLT Classification code 10046721 Term: Urothelial carcinoma bladder stage III System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: MPDL3280A-Ro5541267-F03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Atezoliziumab
Current Sponsor code: RO5541267
Other descriptive name: Atezolizumab
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
INN or Proposed INN: Docetaxel
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-

Primary Outcome(s)

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

Primary end point(s): OS

Timepoint(s) of evaluation of this end point: every 3 months until death, loss to follow-up, or study termination by the Sponsor

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

Secondary Outcome(s)

Secondary end point(s): overall response rate (ORR), progression free survival (PFS), duration of response (DOR)

Timepoint(s) of evaluation of this end point: Every 9 weeks for 54 weeks and every 12 weeks thereafter until disease progression

Secondary ID(s)

GO29294

2014-003231-19-CZ

Source(s) of Monetary Support

F. Hoffmann -La Roche Ltd