Advanced tumor and metastastic disease MedDRA version: 17.1 Level: LLT Classification code 10046721 Term: Urothelial carcinoma bladder stage III System Organ Class: 100000004864
Conditions
Interventions
Product Name: MPDL3280A-RO5541267-F-03
Pharmaceutical Form: Solution for infusion
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 176
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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 ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
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
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd
Outcome results
None listed