FOLLOW-UP STUDY OF ATEZOLIZUMAB FOR UC
- Conditions
- rothelial cancer
- Registration Number
- JPRN-jRCT2080223372
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse event incidence, type, and severity based on NCI CTCAE v4.0
- Secondary Outcome Measures
Name Time Method efficacy<br>Evaluation using RECIST v1.1 and modified RECIST