A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)

Completed · Phase 2

Conditions studied: Bladder Cancer

In brief

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 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). 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.

Key facts

Study ID

NCT02951767

Run by

Hoffmann-La Roche

People needed

119

Starts

2014-05-31

Expected to finish

2023-02-28

Last updated by the study team

2024-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 1-Specific Inclusion Criteria
• No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma
• Ineligible for cisplatin-based chemotherapy due to one of the following: Impaired renal function, a hearing loss of 25 decibels (dB) at two contiguous frequencies, Grade 2 or greater peripheral neuropathy, or ECOG performance score of 2

You may not qualify if…

• 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

Where it is running

• Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
• Arizona Oncology - HOPE Wilmot — Tucson, Arizona, United States
• UCLA — Los Angeles, California, United States
• The Angeles Clinic and Research Institute - W LA Office — Los Angeles, California, United States
• USC Norris Cancer Center — Los Angeles, California, United States
• UCSF — San Francisco, California, United States
• Kaiser Permanente - San Marcos — San Marcos, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Kaiser Permanente; Oncology Clinical Trials — Vallejo, California, United States
• Rocky Mountain Cancer Center - Aurora — Aurora, Colorado, United States
• University Of Colorado — Aurora, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Yale Cancer Center ; Medical Oncology — New Haven, Connecticut, United States
• Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Mayo Clinic Cancer Center — Jacksonville, Florida, United States
• Piedmont Cancer Institute, PC — Atlanta, Georgia, United States
• University of Chicago; Hematology/Oncology — Chicago, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Indiana University Health; Goshen Center for Cancer Care — Goshen, Indiana, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Massachusetts General Hospital;Oncology — Boston, Massachusetts, United States
• Dana Farber Cancer Inst. ; Dept. of Medical Oncology — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center, Harvard Medical School; Department of Medicine — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• University of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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