Clinical trial NCT03661320: A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
Official title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Urinary Bladder Neoplasms
Muscle-Invasive Bladder Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2018-09-07
Enrollment: 855
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: The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).


Eligibility criteria: Inclusion Criteria:

* Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

* Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
* Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Primary outcomes:
measure: Pathological Complete Response (pCR) rate, in all randomized participants
timeFrame: Approximately 43 months
measure: Event-Free Survival (EFS), in all randomized participants
timeFrame: Approximately 36 months
Secondary outcomes:
measure: Overall Survival (OS) in all randomized participants
timeFrame: Approximately 60 months
measure: Incidence of Adverse Events (AE) in participants who received at least one treatment dose
timeFrame: Approximately 60 months
measure: Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose
timeFrame: Approximately 60 months
measure: Incidence of deaths in participants who received at least one treatment dose
timeFrame: Approximately 60 months
measure: Incidence of laboratory abnormalities in participants who received at least one treatment dose
timeFrame: Approximately 60 months
measure: pCR rate, descriptively in all concurrently randomized participants
timeFrame: Approximately 43 months
measure: EFS, descriptively in all concurrently randomized participants
timeFrame: Approximately 36 months
measure: OS, descriptively in all concurrently randomized participants
timeFrame: Approximately 60 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0022
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Littleton
country: United States
facility: Local Institution - 0021
state: Colorado
city: Pensacola
country: United States
facility: Local Institution - 0036
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0004
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0144
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0005
state: Illinois
city: Peoria
country: United States
facility: Local Institution - 0006
state: Illinois
city: Columbia
country: United States
facility: Local Institution - 0181
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0009
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0166
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 0209
state: Massachusetts
city: Minneapolis
country: United States
facility: Local Institution - 0025
state: Minnesota
city: Minneapolis
country: United States
facility: Local Institution - 0129
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 0183
state: Nebraska
city: Omaha
country: United States
facility: Local Institution - 0001
state: Nebraska
city: Las Vegas
country: United States
facility: Local Institution - 0024
state: Nevada
city: Albany
country: United States
facility: Local Institution - 0029
state: New York
city: Lake Success
country: United States
facility: Local Institution - 0069
state: New York
city: New York
country: United States
facility: Local Institution - 0047
state: New York
city: Cleveland
country: United States
facility: Local Institution - 0191
state: Ohio
city: Tigard
country: United States
facility: Local Institution - 0028
state: Oregon
city: Charleston
country: United States
facility: Local Institution - 0189
state: South Carolina
city: Nashville
country: United States
facility: Local Institution - 0007
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 0030
state: Texas
city: Norfolk
country: United States
facility: Local Institution - 0023
state: Virginia
city: Capital Federal
country: Argentina
facility: Local Institution - 0051
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0049
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Local Institution - 0151
state: Distrito Federal
city: Garran
country: Australia
facility: Local Institution - 0131
state: Australian Capital Territory
city: Kingswood
country: Australia
facility: Local Institution - 0130
state: New South Wales
city: Macquarie University
country: Australia
facility: Local Institution - 0157
state: New South Wales
city: St Leonards
country: Australia
facility: Local Institution - 0043
state: New South Wales
city: North Adelaide
country: Australia
facility: Local Institution - 0143
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution - 0037
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0038
state: Western Australia
city: Klagenfurt Am Woerthersee
country: Austria
facility: Local Institution - 0090
city: Krems
country: Austria
facility: Local Institution - 0091
city: Linz
country: Austria
facility: Local Institution - 0011
city: Wien
country: Austria
facility: Local Institution - 0012
city: Bruxelles
country: Belgium
facility: Local Institution - 0060
city: Gent
country: Belgium
facility: Local Institution - 0063
city: Wilrijk
country: Belgium
facility: Local Institution - 0062
city: Fortaleza
country: Brazil
facility: Local Institution - 0094
state: Ceara
city: Ipatinga
country: Brazil
facility: Local Institution - 0099
state: Minas Gerais
city: Ijui
country: Brazil
facility: Local Institution - 0092
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0212
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0097
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0098
state: Sao Paulo
city: Jau
country: Brazil
facility: Local Institution - 0095
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution - 0093
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution - 0164
city: Sao Paulo
country: Brazil
facility: Local Institution - 0214
city: Kelowna
country: Canada
facility: Local Institution - 0159
state: British Columbia
city: North York
country: Canada
facility: Local Institution - 0182
state: Ontario
city: Chicoutimi
country: Canada
facility: Local Institution - 0192
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0190
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0053
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0052
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0210
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0054
state: Metropolitana
city: Colombia
country: Colombia
facility: Local Institution - 0201
state: Bogota
city: Bucaramanga
country: Colombia
facility: Local Institution - 0104
city: Monteria
country: Colombia
facility: Local Institution - 0103
city: Helsinki
country: Finland
facility: Local Institution - 0148
city: Tampere
country: Finland
facility: Local Institution - 0145
city: Turku
country: Finland
facility: Local Institution - 0146
city: Brest
country: France
facility: Local Institution - 0202
state: Finistère
city: Créteil
country: France
facility: Local Institution - 0204
state: Val-de-Marne
city: Amiens
country: France
facility: Local Institution - 0205
city: Angers
country: France
facility: Local Institution - 0198
city: Besancon
country: France
facility: Local Institution - 0101
city: Bordeaux
country: France
facility: Local Institution - 0217
city: Clermont-ferrand
country: France
facility: Local Institution - 0199
city: La Tronche
country: France
facility: Local Institution - 0206
city: Marseille
country: France
facility: Local Institution - 0075
city: Montpellier Cedex 5
country: France
facility: Local Institution - 0200
city: Nice
country: France
facility: Local Institution - 0074
city: Paris
country: France
facility: Local Institution - 0163
city: Pierre Benite Cedax
country: France
facility: Local Institution - 0020
city: Saint Herblain Cedex
country: France
facility: Local Institution - 0188
city: Strasbourg Cedex
country: France
facility: Local Institution - 0002
city: TOULOUSE Cedex 9
country: France
facility: Local Institution - 0003
city: Mainz
country: Germany
facility: Local Institution - 0100
state: Rheinland-Pfalz
city: Aachen
country: Germany
facility: Local Institution - 0078
city: Erfurt
country: Germany
facility: Local Institution - 0015
city: Essen
country: Germany
facility: Local Institution - 0081
city: Frankfurt Main
country: Germany
facility: Local Institution - 0086
city: Goettingen
country: Germany
facility: Local Institution - 0080
city: Herne
country: Germany
facility: Local Institution - 0013
city: Jena
country: Germany
facility: Local Institution - 0010
city: Luebeck
country: Germany
facility: Local Institution - 0084
city: Magdeburg
country: Germany
facility: Local Institution - 0079
city: Muenchen
country: Germany
facility: Local Institution - 0082
city: Nuernberg
country: Germany
facility: Local Institution - 0016
city: Trier
country: Germany
facility: Local Institution - 0085
city: Athens
country: Greece
facility: Local Institution - 0195
state: Attikí
city: Larissa
country: Greece
facility: Local Institution - 0031
state: Thessalía
city: Chaidari
country: Greece
facility: Local Institution - 0194
city: Tel Aviv
country: Israel
facility: Local Institution - 0196
state: Tel-Aviv
city: Beer Sheva
country: Israel
facility: Local Institution - 0068
city: Haifa
country: Israel
facility: Local Institution - 0066
city: Ramat Gan
country: Israel
facility: Local Institution - 0067
city: Bari
country: Italy
facility: Local Institution - 0064
city: Meldola (fc)
country: Italy
facility: Local Institution - 0193
city: Milano
country: Italy
facility: Local Institution - 0032
city: Modena
country: Italy
facility: Local Institution - 0065
city: Padova
country: Italy
facility: Local Institution - 0033
city: Pisa
country: Italy
facility: Local Institution - 0034
city: Roma
country: Italy
facility: Local Institution - 0035
city: Komaki
country: Japan
facility: Local Institution - 0186
state: Aichi
city: Sapporo
country: Japan
facility: Local Institution - 0184
state: Hokkaido
city: Sapporo
country: Japan
facility: Local Institution - 0177
state: Hokkaido
city: Sapporo
country: Japan
facility: Local Institution - 0185
state: Hokkaido
city: Tsukuba-shi
country: Japan
facility: Local Institution - 0179
state: Ibaraki
city: Kita-gun
country: Japan
facility: Local Institution - 0171
state: Kagawa
city: Yokohama
country: Japan
facility: Local Institution - 0169
state: Kanagawa
city: Niigata-shi
country: Japan
facility: Local Institution - 0168
state: Niigata
city: Osakasayama
country: Japan
facility: Local Institution - 0173
state: Osaka
city: Takatsuki City
country: Japan
facility: Local Institution - 0175
state: Osaka
city: Hidaka-shi
country: Japan
facility: Local Institution - 0176
state: Saitama
city: Hamamatasu
country: Japan
facility: Local Institution - 0170
state: Shizuoka
city: Minato-ku
country: Japan
facility: Local Institution - 0178
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0172
state: Tokyo
city: Fukuoka
country: Japan
facility: Local Institution - 0174
city: Kyoto
country: Japan
facility: Local Institution - 0180
city: Goyang-si
country: Korea, Republic of
facility: Local Institution - 0137
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0203
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Local Institution - 0220
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0218
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Local Institution - 0208
city: Seongnam-si,
country: Korea, Republic of
facility: Local Institution - 0215
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0140
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0136
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0211
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0138
city: La Paz
country: Mexico
facility: Local Institution - 0160
state: BAJA Californa SUR
city: Zapopan
country: Mexico
facility: Local Institution - 0102
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0056
state: Nuevo LEON
city: Colima
country: Mexico
facility: Local Institution - 0105
city: Amsterdam
country: Netherlands
facility: Local Institution - 0070
city: Groningen
country: Netherlands
facility: Local Institution - 0072
city: Sittard-Geleen
country: Netherlands
facility: Local Institution - 0073
city: Auckland
country: New Zealand
facility: Local Institution - 0087
city: Christchurch
country: New Zealand
facility: Local Institution - 0089
city: Gralum
country: Norway
facility: Local Institution - 0158
city: Lorenskog
country: Norway
facility: Local Institution - 0132
city: Oslo
country: Norway
facility: Local Institution - 0133
city: Lisboa
country: Portugal
facility: Local Institution - 0153
city: Porto
country: Portugal
facility: Local Institution - 0152
city: Cluj-Napoca
country: Romania
facility: Local Institution - 0219
city: Craiova
country: Romania
facility: Local Institution - 0076
city: Sector 2
country: Romania
facility: Local Institution - 0058
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution - 0154
city: Lugo
country: Spain
facility: Local Institution - 0113
city: Madrid
country: Spain
facility: Local Institution - 0111
city: Madrid
country: Spain
facility: Local Institution - 0112
city: Madrid
country: Spain
facility: Local Institution - 0114
city: Malaga
country: Spain
facility: Local Institution - 0156
city: Sevilla
country: Spain
facility: Local Institution - 0109
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0135
city: Taichung
country: Taiwan
facility: Local Institution - 0165
city: Taipei City
country: Taiwan
facility: Local Institution - 0141
city: Taipei
country: Taiwan
facility: Local Institution - 0139
city: Chelmsford
country: United Kingdom
facility: Local Institution - 0128
state: Essex
city: York
country: United Kingdom
facility: Local Institution - 0127
state: Yorkshire
city: Glasgow
country: United Kingdom
facility: Local Institution - 0122
city: Lancaster
country: United Kingdom
facility: Local Institution - 0117
city: London
country: United Kingdom
facility: Local Institution - 0121
city: Oxford
country: United Kingdom
facility: Local Institution - 0124
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.