Clinical trial NCT03519256: A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
Official title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urinary Bladder Neoplasms
Keywords: Bladder Cancer
BCG-unresponsive
Nivolumab
Intravesical BCG
NMIBC
Non-Muscle Invasive
BMS-986205
CheckMate 9UT
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.


Eligibility criteria: Inclusion Criteria:

* Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component
* Participants must have CIS to be eligible.
* Predominant histologic component (\> 50%) must be urothelial (transitional cell) carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Sign of locally advanced disease or metastatic bladder cancer
* Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
* Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants Immune-Mediated Adverse Events (IMAEs)
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants Who Died
timeFrame: From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)
measure: Number of Participants With Specific Liver Laboratory Abnormalities
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants With Specific Thyroid Laboratory Abnormalities
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants With Changes From Baseline Laboratory Values
timeFrame: From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
measure: Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status
timeFrame: From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0044
state: California
city: Riverside
country: United States
facility: Local Institution - 0081
state: California
city: San Francisco
country: United States
facility: Local Institution - 0087
state: California
city: Tampa
country: United States
facility: Local Institution - 0125
state: Florida
city: Hapeville
country: United States
facility: Local Institution - 0056
state: Georgia
city: New Lenox
country: United States
facility: Local Institution - 0023
state: Illinois
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Baltimore
country: United States
facility: Local Institution - 0001
state: Maryland
city: Ann Arbor
country: United States
facility: Local Institution - 0077
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution - 0032
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 0040
state: Nebraska
city: New Brunswick
country: United States
facility: Local Institution - 0144
state: New Jersey
city: Voorhees
country: United States
facility: Deleware Valley Urology, LLC
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0051
state: New York
city: Columbus
country: United States
facility: Local Institution - 0058
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Local Institution - 0036
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0049
state: South Carolina
city: Myrtle Beach
country: United States
facility: Local Institution - 0002
state: South Carolina
city: Chattanooga
country: United States
facility: Local Institution - 0057
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics Of North Texas, Pa
state: Texas
city: Houston
country: United States
facility: Local Institution - 0048
state: Texas
city: Houston
country: United States
facility: Local Institution - 0140
state: Texas
city: Lubbock
country: United States
facility: Local Institution - 0047
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research, Pa
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0141
state: Washington
city: Capital Federal
country: Argentina
facility: Local Institution - 0068
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0065
state: Distrito Federal
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Local Institution - 0089
state: Distrito Federal
city: Viedma
country: Argentina
facility: Local Institution
state: RIO Negro
city: Cordoba
country: Argentina
facility: Instituto Oncologico De Cordoba
city: Mendoza
country: Argentina
facility: Local Institution - 0137
city: Camperdown
country: Australia
facility: Local Institution - 0146
state: New South Wales
city: St Leonards
country: Australia
facility: Local Institution - 0148
state: New South Wales
city: Fortaleza
country: Brazil
facility: Local Institution - 0072
state: Ceara
city: Curitiba
country: Brazil
facility: Local Institution - 0151
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution - 0073
state: RIO Grande DO SUL
city: Itacorubi, Florianopolis
country: Brazil
facility: Local Institution
state: Santa Catarina
city: Jau
country: Brazil
facility: Local Institution - 0078
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0150
city: Sao Paulo
country: Brazil
facility: Local Institution - 0074
city: North York
country: Canada
facility: Local Institution - 0143
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0086
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0084
state: Ontario
city: Quebec City
country: Canada
facility: Local Institution - 0046
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0154
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0069
state: Metropolitana
city: Beijing
country: China
facility: Local Institution - 0128
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0131
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0116
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0099
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0129
state: Chongqing
city: Fuzhou
country: China
facility: Local Institution - 0108
state: Fujian
city: Guangzhou
country: China
facility: Local Institution - 0117
state: Guangdong
city: Nanjing
country: China
facility: Local Institution - 0102
state: Jiangsu
city: Nan Chang
country: China
facility: Local Institution - 0109
state: Jiangxi
city: Jinan
country: China
facility: Local Institution - 0112
state: Shandong
city: Yantai
country: China
facility: Local Institution - 0111
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0098
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0094
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0097
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0120
state: Sichuan
city: Tianjin
country: China
facility: Local Institution - 0133
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution - 0126
state: Zhejiang
city: Suresnes
country: France
facility: Local Institution - 0027
state: Hauts-de-Seine
city: Angers
country: France
facility: Local Institution - 0028
state: Maine-et-Loire
city: Bordeaux Cedex
country: France
facility: Local Institution - 0031
city: Lille
country: France
facility: Local Institution - 0088
city: Strasbourg
country: France
facility: Local Institution - 0091
city: Hong Kong
country: Hong Kong
facility: Local Institution - 0093
city: Milano
country: Italy
facility: IRCCS Istituto Nazionale Tumori Milano
city: Napoli
country: Italy
facility: Instituto Nazionale Tumori Fondazione G. Pascale
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Tuxtla Gutierrez
country: Mexico
facility: Local Institution - 0062
state: Chiapas
city: Ciudad de Mexico
country: Mexico
facility: Local Institution - 0055
state: Distrito Federal
city: Amsterdam
country: Netherlands
facility: Local Institution - 0004
city: Nijmegen
country: Netherlands
facility: Local Institution - 0003
city: Utrecht
country: Netherlands
facility: Local Institution - 0005
city: Omsk
country: Russian Federation
facility: Local Institution - 0070
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0054
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0153
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution - 0033
city: Santander
country: Spain
facility: Local Institution - 0139
city: Valencia
country: Spain
facility: Local Institution - 0136
city: Chelmsford
country: United Kingdom
facility: Local Institution
state: Essex
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Southampton
country: United Kingdom
facility: Local Institution - 0013
state: Hampshire
city: Lancaster
country: United Kingdom
facility: Local Institution - 0015
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: