Clinical trial NCT02387996: A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer
Official title: A Phase II Single Arm Clinical Trial of Nivolumab (BMS-936558) in Subjects With Metastatic or Unresectable Urothelial Cancer Who Have Progressed or Recurred Following Treatment With a Platinum Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Various Advanced Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-03-13
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose the study is to measure the effect of nivolumab (BMS-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.


Eligibility criteria: Inclusion Criteria:

* Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis
* 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:

* Subjects with active cancer that has spread to the central nervous system
* 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)

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Objective Response Rate Per BIRC Assessment
timeFrame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)
measure: ORR Per BIRC Assessment by PD-L1 Expression Level
timeFrame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)
measure: Time to Response (TTR)
timeFrame: From first dosing date to the date of the first confirmed response (up to approximately 14 months)
measure: Duration of Response (DOR)
timeFrame: From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From first dosing date to the date of the first documented tumor progression (up to approximately 6 months)
measure: Overall Survival (OS)
timeFrame: From first dosing date to the date of death (up to approximately 23 months)
measure: Objective Response Rate (ORR) Per Investigator
timeFrame: From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 45 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0013
state: Arizona
city: Duarte
country: United States
facility: Local Institution - 0012
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Aurora
country: United States
facility: Local Institution - 0016
state: Colorado
city: Athens
country: United States
facility: University Cancer Blood Ctr
state: Georgia
city: Fort Wayne
country: United States
facility: Ft. Wayne Med Onco-Hema Inc
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 0030
state: Indiana
city: Iowa City
country: United States
facility: Local Institution - 0052
state: Iowa
city: Marrero
country: United States
facility: Crescent City Research Consortium, LLC
state: Louisiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Omaha
country: United States
facility: GU Research Network, LLC
state: Nebraska
city: New York
country: United States
facility: Local Institution - 0028
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0004
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0051
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution - 0029
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0059
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Oncology & Hematology - Univ. of TN
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 0001
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0036
state: Washington
city: Waratah
country: Australia
facility: Local Institution - 0060
state: New South Wales
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0070
state: South Australia
city: Brussels
country: Belgium
facility: Local Institution - 0022
city: Edegem
country: Belgium
facility: Local Institution - 0023
city: Hasselt
country: Belgium
facility: Local Institution - 0024
city: Brno
country: Czechia
facility: Local Institution - 0027
city: Olomouc
country: Czechia
facility: Local Institution - 0026
city: Praha 5
country: Czechia
facility: Local Institution
city: Helsinki
country: Finland
facility: Local Institution - 0010
city: Tampere
country: Finland
facility: Local Institution - 0009
city: Erfurt
country: Germany
facility: Local Institution - 0049
city: Erlangen
country: Germany
facility: Local Institution - 0047
city: Hamburg
country: Germany
facility: Local Institution - 0042
city: Heidelberg
country: Germany
facility: Local Institution - 0043
city: Jena
country: Germany
facility: Local Institution - 0015
city: Muenchen
country: Germany
facility: Local Institution - 0041
city: Rostock
country: Germany
facility: Local Institution
city: Tuebingen
country: Germany
facility: Local Institution - 0048
city: Arezzo
country: Italy
facility: Local Institution - 0017
city: Milano
country: Italy
facility: Local Institution - 0020
city: Napoli
country: Italy
facility: Local Institution - 0018
city: Pavia
country: Italy
facility: Local Institution - 0050
city: Roma
country: Italy
facility: Local Institution - 0021
city: Akita-shi
country: Japan
facility: Local Institution - 0074
state: Akita
city: Hirosaki-shi
country: Japan
facility: Local Institution - 0083
state: Aomori
city: Tsukuba-shi
country: Japan
facility: Local Institution - 0081
state: Ibaraki
city: Morioka-shi
country: Japan
facility: Local Institution - 0078
state: Iwate
city: Yokohama
country: Japan
facility: Local Institution
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Local Institution - 0080
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Local Institution - 0082
state: Kyoto
city: Niigata-shi
country: Japan
facility: Local Institution - 0076
state: Niigata
city: Osaka-Sayama-Shi
country: Japan
facility: Local Institution - 0084
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0085
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0073
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0077
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0086
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0075
state: Tokyo
city: Gdansk
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution - 0046
city: Lodz
country: Poland
facility: Local Institution - 0040
city: Szczecin
country: Poland
facility: Local Institution - 0056
city: Wroclaw
country: Poland
facility: Local Institution - 0038
city: Badalona-barcelona
country: Spain
facility: Local Institution - 0035
city: Barcelona
country: Spain
facility: Local Institution - 0033
city: Hospitalet de Llobregat - Barcelona
country: Spain
facility: Local Institution - 0034
city: Madrid
country: Spain
facility: Local Institution - 0031
city: Sevilla
country: Spain
facility: Local Institution - 0032
city: Lund
country: Sweden
facility: Local Institution - 0014
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.