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



Status:Active, not recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:May 31, 2014
End Date:May 18, 2019

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

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.


Inclusion 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.

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
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
We found this trial at
48
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333 Cedar Street
New Haven, Connecticut 06520
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Albany, New York 12206
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Atlanta, Georgia 30318
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Aurora, Colorado 80012
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Aurora, Colorado 80045
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100 Blossom Street
Boston, Massachusetts 02114
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450 Brookline Avenue
Boston, Massachusetts 02115
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5841 South Maryland Avenue
Chicago, Illinois 60637
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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10900 Euclid Avenue
Cleveland, Ohio 44106
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Detroit, Michigan 48201
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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925 Gessner Road
Houston, Texas 77024
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Jacksonville, Florida 32224
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399 Royal Avenue
Kelowna, British Columbia V1Y 5L3
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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11818 Wilshire Boulevard
Los Angeles, California 90025
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Los Angeles, California 90033
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Louisville, Kentucky 40207
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910 East 26th Street
Minneapolis, Minnesota 55404
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New York, New York 10016
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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5900 Lake Wright Drive
Norfolk, Virginia 23502
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Philadelphia, Pennsylvania 19107
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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1635 Divisadero Street
San Francisco, California 94143
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San Marcos, California 92078
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Scottsdale, Arizona 85258
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Stanford, California 94305
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6565 East Carondelet Drive
Tucson, Arizona 85710
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Vallejo, California 94589
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Washington, District of Columbia 20057
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