A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]



Status:Completed
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:January 13, 2015
End Date:November 8, 2018

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A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study
designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in
participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have
progressed during or following a platinum-containing regimen. The anticipated time on study
treatment is based on continued clinical benefit, i.e., until disease progression or
unacceptable toxicity. The target sample size is 931 participants.


Inclusion Criteria:

- Histologically or cytologically documented locally advanced or metastatic UBC
(including renal pelvis, ureters, urinary bladder, and urethra)

- Representative tumor specimens as specified by the protocol

- Disease progression during or following treatment with at least one
platinum-containing regimen for inoperable, locally advanced or metastatic UBC or
disease recurrence

- 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

- For women of childbearing potential, agreement to refrain from heterosexual
intercourse or use contraceptive methods that result in a failure rate of < 1% per
year during the treatment period and for at least 5 months after the last dose of
atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last
dose of paclitaxel or docetaxel.

- For men, agreement to refrain from heterosexual intercourse or use contraceptive
methods that result in a failure rate of < 1% per year during the treatment period and
for at least 3 months after the last dose of vinflunine and 6 months from the last
dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

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

- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception
of those with a negligible risk of metastasis or death and treated with expected
curative outcome, or localized prostate cancer treated with curative intent and
absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

- Pregnant and lactating women

- Significant cardiovascular disease

- Severe infections within 4 weeks prior to randomization

- Major surgical procedure other than for diagnosis within 4 weeks prior to
randomization

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy
to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the
atezolizumab formulation

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplant

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan

- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or
hepatitis C or tuberculosis

- Administration of a live, attenuated vaccine within 4 weeks prior to randomization

- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated
protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed
death-ligand 1 (anti-PD-L1) therapeutic antibodies
We found this trial at
7
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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Atlanta, GA
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Durham, North Carolina 27710
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Durham, NC
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Greenville, South Carolina 29601
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Greenville, SC
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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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Las Vegas, NV
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Washington, District of Columbia 20057
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Washington,
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