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 |
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.
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
sites
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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
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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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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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450 Brookline Avenue
Boston, Massachusetts 02115
Boston, Massachusetts 02115
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330 Brookline Avenue
Boston, Massachusetts 02215
Boston, Massachusetts 02215
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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
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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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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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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
Los Angeles, California 90025
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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
Norfolk, Virginia 23502
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