Bladder cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Atezolizumab
INN of investigational material : atezolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investig
Sponsors
Chugai Pharmaceutical Co., Ltd.
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra) - Representative tumor specimens as specified by the protocol - Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy >= 12 weeks - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Adequate hematologic and end organ function - For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception as defined by the protocol and to continue its use for 6 months after the last dose of MPDL3280A
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 computed tomography (CT) or magnetic resonance imaging (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 and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer - Pregnant and lactating women - Significant cardiovascular disease - Severe infections within 4 weeks prior to randomization - Major surgical procedure other than for diagnosis within 4 weeks prior to randomization - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation - History of autoimmune disease - Prior allogeneic stem cell or solid organ transplant - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan - Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis - Administration of a live, attenuated vaccine within 4 weeks prior to randomization - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory Observation | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics RECIST version1.1, etc | — |
Countries
29 countries including Japan, Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed