A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
NCT ID: NCT02387996
Last Updated: 2022-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
270 participants
INTERVENTIONAL
2015-03-09
2021-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab
Nivolumab intravenous infusion as specified
Nivolumab
Interventions
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Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease by CT or MRI
* Progression or recurrence after treatment
* i) With at least 1 platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or
* ii) Within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
* Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
* Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
* Subject with active, known or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
* Prior treatment with an anti-PD-1,anti-PD-L1,anti-PD-L2,anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti-CD137 or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Exclusion laboratory criteria:
* Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* Known history of testing positive for human Immunodeficiency virus (HIV) or known acquired Immunodeficiency syndrome (AIDS)
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0013
Phoenix, Arizona, United States
Local Institution - 0012
Duarte, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Local Institution - 0016
Aurora, Colorado, United States
University Cancer Blood Ctr
Athens, Georgia, United States
Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana, United States
Local Institution - 0030
Indianapolis, Indiana, United States
Local Institution - 0052
Iowa City, Iowa, United States
Crescent City Research Consortium, LLC
Marrero, Louisiana, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
GU Research Network, LLC
Omaha, Nebraska, United States
Local Institution - 0028
New York, New York, United States
Local Institution - 0004
Charlotte, North Carolina, United States
Local Institution - 0051
Portland, Oregon, United States
Local Institution - 0029
Philadelphia, Pennsylvania, United States
Local Institution - 0059
Pittsburgh, Pennsylvania, United States
Erlanger Oncology & Hematology - Univ. of TN
Chattanooga, Tennessee, United States
Local Institution - 0001
Houston, Texas, United States
Local Institution - 0036
Seattle, Washington, United States
Local Institution - 0060
Waratah, New South Wales, Australia
Local Institution - 0070
Elizabeth Vale, South Australia, Australia
Local Institution - 0022
Brussels, , Belgium
Local Institution - 0023
Edegem, , Belgium
Local Institution - 0024
Hasselt, , Belgium
Local Institution - 0027
Brno, , Czechia
Local Institution - 0026
Olomouc, , Czechia
Local Institution
Prague, , Czechia
Local Institution - 0010
Helsinki, , Finland
Local Institution - 0009
Tampere, , Finland
Local Institution - 0049
Erfurt, , Germany
Local Institution - 0047
Erlangen, , Germany
Local Institution - 0042
Hamburg, , Germany
Local Institution - 0043
Heidelberg, , Germany
Local Institution - 0015
Jena, , Germany
Local Institution - 0041
München, , Germany
Local Institution
Rostock, , Germany
Local Institution - 0048
Tübingen, , Germany
Local Institution - 0017
Arezzo, , Italy
Local Institution - 0020
Milan, , Italy
Local Institution - 0018
Napoli, , Italy
Local Institution - 0050
Pavia, , Italy
Local Institution - 0021
Roma, , Italy
Local Institution - 0074
Akita, Akita, Japan
Local Institution - 0083
Hirosaki-shi, Aomori, Japan
Local Institution - 0081
Tsukuba, Ibaraki, Japan
Local Institution - 0078
Morioka, Iwate, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution - 0080
Kumamoto, Kumamoto, Japan
Local Institution - 0082
Kyoto, Kyoto, Japan
Local Institution - 0076
Niigata, Niigata, Japan
Local Institution - 0084
Osaka-Sayama-Shi, Osaka, Japan
Local Institution - 0085
Bunkyo-ku, Tokyo, Japan
Local Institution - 0073
Bunkyo-ku, Tokyo, Japan
Local Institution - 0077
Bunkyo-ku, Tokyo, Japan
Local Institution - 0086
Shinjuku-ku, Tokyo, Japan
Local Institution - 0075
Shinjuku-ku, Tokyo, Japan
Local Institution
Gdansk, , Poland
Local Institution - 0046
Krakow, , Poland
Local Institution - 0040
Lodz, , Poland
Local Institution - 0056
Szczecin, , Poland
Local Institution - 0038
Wroclaw, , Poland
Local Institution - 0035
Badalona-barcelona, , Spain
Local Institution - 0033
Barcelona, , Spain
Local Institution - 0034
Hospitalet de Llobregat - Barcelona, , Spain
Local Institution - 0031
Madrid, , Spain
Local Institution - 0032
Seville, , Spain
Local Institution - 0014
Lund, , Sweden
Countries
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References
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Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JA, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):312-322. doi: 10.1016/S1470-2045(17)30065-7. Epub 2017 Jan 26.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA209-275
Identifier Type: -
Identifier Source: org_study_id
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