A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)

Not Recruiting

Trial ID: NCT02108652


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.

Official Title

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - Histologically or cytologically documented locally advanced or metastatic transitional
   cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder,

   - 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.

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 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

   - 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

   - 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


drug: Atezolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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