A Study of atezolizumab Compared with Chemotherapy in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer
- Conditions
- Bladder cancer
- Registration Number
- JPRN-jRCT2080222688
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
In this randomized study, the primary endpoint was not met in patients with metastatic urothelial carcinoma with PD-L1 expression as IC2/3. This study showed favorable safety profile of atezolizumab in comparison with chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 931
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>Observation
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>RECIST version1.1, etc