Urothelial cancer
Conditions
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >/= 18 years - Histologically or cytologically documented locally advanced (T4b, any N; or any T, N 2-3) or metastatic (M1, Stage IV) UC - Patients with treated asymptomatic central nervous system metastases are eligible, provided they meet the criteria described in the protocol - Disease progression during or following treatment with platinum-containing regimen (up as far as one 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 - Adequate hematologic and end organ function - For female patients of childbearing potential, agreement to use highly effective form(s) of contraception as defined by the protocol and to continue its use for 5 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 - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) - Uncontrolled tumor-related pain - Hypercalcemia - Malignancies other than UBC within 5 years prior to enrollment - Pregnant and lactating women - Uncontrolled concomitant disease including significant liver disease - Significant cardiovascular disease - Severe infections within 4 weeks prior to enrollment - Therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to enrollment - 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 - Low serum albumin - Positive test for HIV - Active hepatitis B or hepatitis C or tuberculosis - Administration of a live, attenuated vaccine within 4 weeks prior to enrollment - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies - Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment - Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to enrollment - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of disease or a condition that contraindicates the use of the investigational drug or renders the patient at high risk for treatment complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse event incidence, type, and severity based on NCI CTCAE v4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Evaluation using RECIST v1.1 and modified RECIST | — |
Countries
Japan
Outcome results
None listed