A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Description
Brief Summary
This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment
in participants with locally advanced or metastatic urothelial bladder cancer. Participants
will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of participants who are
treatment-naïve and ineligible for cisplatin-containing chemotherapy. The results of Cohort 1
are reported separately (NCT02951767). Cohort 2 (reported here) will contain participants who
have progressed during or following a prior platinum-based chemotherapy regimen. Participants
in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on
Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease
progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or
unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of
clinical benefit or unmanageable toxicity.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion Criteria
- 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 greater than or equal to (>=) 12 weeks
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function Cohort 2-Specific Inclusion Criteria
- 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.
- A regimen was defined as participants receiving at least two cycles of a platinum-containing regimen. Participants who had received one cycle of a platinum-containing regimen but discontinued due to Grade 4 hematologic toxicity or Grade 3 or 4 non-hematologic toxicity could also be eligible.
- Participants who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen were considered as second-line participants.
- 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 tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Uncontrolled hypercalcemia (greater than [>] 1.5 millimoles per liter [mmol/L] ionized calcium or Ca > 12 milligrams per deciliter [mg/dL] or corrected serum calcium > upper limits of normal [ULN]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- Malignancies other than urothelial bladder cancer 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 less than (<) 2.5 grams per deciliter (g/dL)
- Positive test for human immunodeficiency virus (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 therapies, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
Sites
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California
- Unknown facility, Los Angeles, California, 90024
- Unknown facility, Los Angeles, California, 90024
- Unknown facility, Los Angeles, California, 90025
- Unknown facility, San Marcos, California, 92069
- Unknown facility, San Marcos, California, 92069
- Unknown facility, Vallejo, California, 94589
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Arizona
- Unknown facility, Scottsdale, Arizona, 85258
- Unknown facility, Scottsdale, Arizona, 85258
- Unknown facility, Tucson, Arizona, 85710
- Unknown facility, Tucson, Arizona, 85710
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Colorado
- Unknown facility, Aurora, Colorado, 80012
- Unknown facility, Aurora, Colorado, 80045
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Washington
- Unknown facility, Seattle, Washington, 98109
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Texas
- Unknown facility, San Antonio, Texas, 78229
- Unknown facility, Fort Worth, Texas, 76104
- Unknown facility, Houston, Texas, 77024
- Unknown facility, Houston, Texas, 77030
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Nebraska
- Unknown facility, Omaha, Nebraska, 68130
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Minnesota
- Unknown facility, Minneapolis, Minnesota, 55404
- Unknown facility, Rochester, Minnesota, 55905
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Illinois
- Unknown facility, Chicago, Illinois, 60637
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Tennessee
- Unknown facility, Nashville, Tennessee, 37203
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Alabama
- Unknown facility, Birmingham, Alabama, 35294
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Indiana
- Unknown facility, Goshen, Indiana, 46526
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Ohio
- Unknown facility, Cincinnati, Ohio, 45242
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Georgia
- Unknown facility, Atlanta, Georgia, 30318
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Germany
- Unknown facility, Freiburg, 79106
- Unknown facility, Freiburg, 79106
- Unknown facility, Düsseldorf, 40225
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France
- Unknown facility, Paris, 75475
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