Clinical trial NCT04149574: A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)
Official title: A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Bladder Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-11-04
Enrollment: 13
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 comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.


Eligibility criteria: Inclusion Criteria:

* Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive
* Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)
* Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

Exclusion Criteria:

* Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC
* UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
* UC and/or CIS in the prostatic urethra within 12 months of enrollment

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Event Free Survival (EFS)
timeFrame: approximately 3 years
Secondary outcomes:
measure: Worsening- Free Survival (WFS)
timeFrame: approximately 3 years
measure: Overall Survival (OS)
timeFrame: approximately 3 years
measure: Complete Response Rate (CRR)
timeFrame: approximately 3 years
measure: Duration of Response (DOR)
timeFrame: approximately 3 years
measure: Number of participants with laboratory abnormalities
timeFrame: approximately 3 years
measure: Number of participants with laboratory changes from baseline
timeFrame: approximately 3 years
measure: Number of participants with Adverse Events (AEs)
timeFrame: approximately 3 years
measure: Number of Deaths
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University Of Chicago
state: Illinois
city: Bronx
country: United States
facility: Local Institution - 0084
state: New York
city: Caba
country: Argentina
facility: Local Institution - 0009
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0088
state: Buenos Aires
city: Ciudad Autonoma Beunos Aires
country: Argentina
facility: Local Institution - 0016
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution - 0081
state: Buenos Aires
city: Viedma
country: Argentina
facility: Local Institution - 0008
state: RIO Negro
city: Buenos Aires
country: Argentina
facility: Local Institution - 0080
city: Cordoba
country: Argentina
facility: Local Institution - 0107
city: Sydney
country: Australia
facility: Local Institution - 0002
state: New South Wales
city: Woolloongabba
country: Australia
facility: Local Institution - 0001
state: Queensland
city: Bowral
country: Australia
facility: Local Institution - 0114
city: Linz
country: Austria
facility: Local Institution - 0097
city: Salzburger
country: Austria
facility: Local Institution - 0104
city: Wels
country: Austria
facility: Local Institution - 0098
city: Wien
country: Austria
facility: Local Institution - 0099
city: Uberlandia
country: Brazil
facility: Local Institution - 0050
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Local Institution - 0048
state: RIO Grande DO SUL
city: Itajai
country: Brazil
facility: Local Institution - 0047
state: Santa Catarina
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0049
city: Toronto
country: Canada
facility: Local Institution - 0017
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0038
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0037
state: Quebec
city: Rimouski
country: Canada
facility: Local Institution - 0012
state: Quebec
city: La Serena
country: Chile
facility: Local Institution - 0011
state: Coquimbo
city: Recoleta
country: Chile
facility: Local Institution - 0010
state: Metropolitana
city: Vina del Mar
country: Chile
facility: Local Institution - 0072
state: Valparaiso
city: Angers Cedex 10
country: France
facility: Local Institution - 0042
city: DIJON Cedex
country: France
facility: Local Institution - 0106
city: Lille
country: France
facility: Local Institution - 0045
city: Marseille Cedex 05
country: France
facility: Local Institution - 0108
city: Paris Cedex 14
country: France
facility: Local Institution - 0103
city: Paris Cedex 18
country: France
facility: Local Institution - 0111
city: Strasbourg
country: France
facility: Local Institution - 0041
city: Villejuif
country: France
facility: Local Institution - 0040
city: Herne
country: Germany
facility: Local Institution - 0094
city: Jena
country: Germany
facility: Local Institution - 0093
city: Koeln
country: Germany
facility: Local Institution - 0105
city: Trier
country: Germany
facility: Local Institution - 0095
city: Haidari
country: Greece
facility: Local Institution - 0031
city: Thessaloniki
country: Greece
facility: Local Institution - 0032
city: Tel Aviv
country: Israel
facility: Local Institution - 0075
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Local Institution - 0073
city: Ramat-gan
country: Israel
facility: Local Institution - 0074
city: Torino
country: Italy
facility: Local Institution - 0067
state: TO
city: Milano
country: Italy
facility: Local Institution - 0062
city: Modena
country: Italy
facility: Local Institution - 0063
city: Napoli
country: Italy
facility: Local Institution - 0064
city: Reggio Emilia
country: Italy
facility: Local Institution - 0065
city: Roma
country: Italy
facility: Local Institution - 0066
city: Nagakute-shi
country: Japan
facility: Local Institution - 0147
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Local Institution - 0158
state: Aomori
city: Sapporo-city
country: Japan
facility: Local Institution - 0161
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Local Institution - 0155
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: Local Institution - 0149
state: Ibaraki
city: Kawasaki-shi
country: Japan
facility: Local Institution - 0146
state: Kanagawa
city: Yokohama City
country: Japan
facility: Local Institution - 0153
state: Kanagawa
city: Nagasaki-shi
country: Japan
facility: Local Institution - 0164
state: Nagasaki
city: Kashihara-shi
country: Japan
facility: Local Institution - 0151
state: Nara
city: Niigata-shi
country: Japan
facility: Local Institution - 0165
state: Niigata
city: Kurashiki-shi
country: Japan
facility: Local Institution - 0156
state: Okayama
city: Hirakata
country: Japan
facility: Local Institution - 0157
state: Osaka
city: Osakasayamashi
country: Japan
facility: Local Institution - 0154
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Local Institution - 0160
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Local Institution - 0159
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0162
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution - 0150
state: Tokyo
city: Wakayama
country: Japan
facility: Local Institution - 0145
city: Arnhem
country: Netherlands
facility: Local Institution - 0054
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution - 0051
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution - 0052
city: Pamplona
country: Spain
facility: Local Institution - 0096
state: Navarra
city: Badajoz
country: Spain
facility: Local Institution - 0061
city: Badalona-barcelona
country: Spain
facility: Local Institution - 0060
city: Madrid
country: Spain
facility: Local Institution - 0055
city: Sabadell
country: Spain
facility: Local Institution - 0059
city: Santander
country: Spain
facility: Local Institution - 0057
city: València
country: Spain
facility: Local Institution - 0058
city: Norrkoping
country: Sweden
facility: Local Institution - 0087
city: Umea
country: Sweden
facility: Local Institution - 0083
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: