A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/20/2018
Start Date:April 28, 2016
End Date:July 24, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A Phase 3, Multicenter, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (MSB0010718C) Plus Best Supportive Care Versus Best Supportive Care Alone As A Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After Completion Of First-line Platinum-containing Chemotherapy

The main purpose of this study is to compare maintenance treatment with avelumab plus best
supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in
patients with locally advanced or metastatic urothelial cancer that did not worsen during or
following completion of first-line chemotherapy.


Inclusion Criteria:

- Histologically confirmed, unresectable locally advanced or metastatic transitional
cell carcinoma of the urothelium

- Stage IV disease at the start of first-line chemotherapy

- Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy

- Prior first-line chemotherapy must have consisted of at least 4 cycles and no more
than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin

- No evidence of progressive disease following completion of first-line chemotherapy
(i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )

Exclusion Criteria:

- Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization

- Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug
specifically targeting T-cell co-stimulation or immune checkpoint pathways

- Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however,
alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse
events not constituting a safety risk based on the investigator's judgement are
acceptable.

- Patients with known symptomatic central nervous system (CNS) metastases requiring
steroids

- Diagnosis of any other malignancy within 5 years prior to randomization, except for
adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the
breast or of the cervix, low grade prostate cancer on surveillance without any plans
for treatment intervention, or prostate cancer that has been adequately treated with
prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.
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Fairfax, Virginia 22031
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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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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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, Georgia 30322
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Aurora, Colorado 80045
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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2010 East 90th Street
Cleveland, Ohio 44195
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Minneapolis, Minnesota 55455
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New Haven, Connecticut 06520
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1115 Avenida de Mayo
Pergamino, Buenos Aires
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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