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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

  • Clinicaltrials.gov identifier

    NCT03661320

  • Recruitment Status

    Recruiting

  • First Posted

    September 7, 2018

  • Last update posted

    June 30, 2022

Study Description

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).

  • Condition or Disease:Urinary Bladder Neoplasms
    Muscle-Invasive Bladder Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Drug: Gemcitabine
    Drug: Cisplatin
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 861 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: November 2018
  • Estimated Primary Completion Date: January 2024
  • Estimated Study Completion Date: January 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Arm B: Nivolumab + GC Chemotherapy
Biological: Nivolumab
Specified dose on specified days

Drug: Gemcitabine
Specified dose on specified days

Drug: Cisplatin
Specified dose on specified days
Active Comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
Drug: Gemcitabine
Specified dose on specified days

Drug: Cisplatin
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approximately 43 months ]
    Arm B vs. Arm A
  • 2. Event-Free Survival (EFS), in all randomized participants [ Time Frame: Approximately 51 months ]
    Arm B vs. Arm A
  • Secondary Outcome Measures: 1. Overall Survival (OS) in all randomized participants [ Time Frame: Approximately 60 months ]
    Arm B vs. Arm A
  • 2. Incidence of Adverse Events (AE) in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  • 3. Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  • 4. Incidence of deaths in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  • 5. Incidence of laboratory abnormalities in participants who received at least one treatment dose [ Time Frame: Approximately 60 months ]
  • 6. pCR rate, descriptively in all concurrently randomized participants [ Time Frame: Approximately 43 months ]
    Arm C vs. Arm B and Arm A
  • 7. EFS, descriptively in all concurrently randomized participants [ Time Frame: Approximately 51 months ]
    Arm C vs. Arm B and Arm A
  • 8. OS, descriptively in all concurrently randomized participants [ Time Frame: Approximately 60 months ]
    Arm C vs. Arm B and Arm A

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com/ 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Alabama
Local Institution
Mobile

United States, Arizona
Local Institution
Chandler

United States, Arizona
Arizona Oncology Associates
Tucson

United States, California
Local Institution
La Jolla

United States, California
Uc Irvine Health
Orange

United States, California
UC Davis Comprehensive Cancer Center
Sacramento

United States, California
Local Institution
San Jose

United States, Colorado
Rocky Mountain Cancer Centers Llp
Littleton

United States, Connecticut
Local Institution
New Haven

United States, Delaware
Local Institution
Newark

United States, Florida
Woodlands Medical Specialists, Pa
Pensacola

United States, Florida
Local Institution - 0004
Tampa

United States, Georgia
Northside Hospital
Atlanta

United States, Illinois
University of Chicago Medical Center
Chicago

United States, Illinois
Illinois Cancer Care
Peoria

United States, Maryland
Local Institution
Baltimore

United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Massachusetts
Cancer Center At Milford Regional Medical Center
Boston

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Minnesota
Minnesota Oncology Hematology
Minneapolis

United States, Minnesota
Local Institution - 0129
Minneapolis

United States, Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha

United States, Nebraska
University Of Nebraska Medical Center
Omaha

United States, Nevada
Comprehensive Cancer Centers Of Nevada
Las Vegas

United States, New Jersey
Local Institution
Camden

United States, New York
New York Oncology Hematology, Pc
Albany

United States, New York
Local Institution - 0069
Lake Success

United States, New York
Columbia University Medical Center (Cumc)
New York

United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland

United States, Oregon
Northwest Cancer Specialists, Pc
Tigard

United States, South Carolina
Medical University Of South Carolina
Charleston

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
Texas Oncology-Central Austin Cancer Center
Austin

United States, Texas
Local Institution
Dallas

United States, Texas
Local Institution
Fort Sam Houston

United States, Virginia
Virginia Oncology Associates
Norfolk

Argentina, Buenos Aires
Local Institution - 0051
Capital Federal

Argentina, Buenos Aires
Local Institution - 0049
Ciudad Autónoma de Buenos Aires

Argentina, Distrito Federal
Local Institution - 0151
Ciudad Autonoma Buenos Aires

Australia, Australian Capital Territory
Local Institution - 0131
Garran

Australia, New South Wales
Local Institution - 0130
Kingswood

Australia, New South Wales
Local Institution - 0157
Macquarie University

Australia, New South Wales
Local Institution - 0043
St Leonards

Australia, South Australia
Local Institution - 0143
North Adelaide

Australia, Victoria
Local Institution - 0037
Heidelberg

Australia, Western Australia
Local Institution - 0038
Murdoch

Austria
Local Institution - 0090
Klagenfurt Am Woerthersee

Austria
Local Institution - 0091
Krems

Austria
Local Institution - 0011
Linz

Austria
Local Institution - 0012
Wien

Belgium
Local Institution - 0060
Bruxelles

Belgium
Local Institution - 0063
Gent

Belgium
Local Institution
Leuven

Belgium
Local Institution - 0062
Wilrijk

Brazil, Ceara
Local Institution - 0094
Fortaleza

Brazil, Minas Gerais
Local Institution - 0099
Ipatinga

Brazil, RIO Grande DO SUL
Local Institution - 0092
Ijui

Brazil, RIO Grande DO SUL
Local Institution - 0212
Porto Alegre

Brazil, RIO Grande DO SUL
Local Institution - 0097
Porto Alegre

Brazil, Sao Paulo
Local Institution - 0098
Barretos

Brazil, Sao Paulo
Local Institution - 0095
Jau

Brazil, Sao Paulo
Local Institution - 0093
Sao Jose Do Rio Preto

Brazil
Local Institution - 0164
Rio De Janeiro

Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
Sao Paulo

Brazil
Local Institution
Sao Paulo

Canada, British Columbia
Local Institution
Abbotsford

Canada, British Columbia
Local Institution - 0159
Kelowna

Canada, Ontario
Local Institution - 0182
North York

Canada, Quebec
Local Institution - 0192
Chicoutimi

Canada, Quebec
Local Institution - 0190
Montreal

Chile, Metropolitana
Local Institution - 0053
Santiago

Chile, Metropolitana
Local Institution - 0052
Santiago

Chile, Metropolitana
Local Institution - 0210
Santiago

Chile, Metropolitana
Local Institution - 0054
Santiago

Colombia, Bogota
Local Institution - 0201
Colombia

Colombia
Local Institution - 0104
Bucaramanga

Colombia
Local Institution - 0103
Monteria

Denmark
Local Institution
?lborg

Denmark
Local Institution
Arhus

Denmark
Local Institution
Herlev

Finland
Local Institution - 0148
Helsinki

Finland
Local Institution - 0145
Tampere

Finland
Local Institution - 0146
Turku

France, Cedex
Local Institution - 0202
Brest

France, Val-de-Marne
Local Institution - 0204
Créteil

France
Local Institution - 0205
Amiens

France
Local Institution - 0198
Angers

France
Local Institution - 0101
Besancon Cedex

France
Local Institution
Bordeaux

France
Local Institution - 0217
Bordeaux

France
Local Institution - 0199
Clermont-ferrand

France
Local Institution - 0206
La Tronche

France
Local Institution - 0075
Marseille

France
Local Institution - 0200
Montpellier Cedex 5

France
Local Institution - 0074
Nice

France
Local Institution - 0163
Paris

France
Local Institution - 0020
Pierre Benite Cedax

France
Local Institution
Rennes Cedex

France
Local Institution - 0188
Saint Herblain Cedex

France
Local Institution - 0002
Strasbourg Cedex

France
Local Institution - 0003
TOULOUSE Cedex 9

Germany
Local Institution - 0078
Aachen

Germany
Local Institution - 0015
Erfurt

Germany
Local Institution - 0081
Essen

Germany
Local Institution - 0086
Frankfurt Main

Germany
Local Institution - 0080
Goettingen

Germany
Local Institution
Heidelberg

Germany
Local Institution - 0013
Herne

Germany
Local Institution - 0010
Jena

Germany
Local Institution - 0084
Luebeck

Germany
Local Institution - 0079
Magdeburg

Germany
Local Institution - 0100
Mainz

Germany
Local Institution - 0082
Muenchen

Germany
Local Institution - 0016
Nuernberg

Germany
Local Institution - 0085
Trier

Greece, Thessalía
Local Institution - 0031
Larissa

Greece
Local Institution
Athens

Greece
Local Institution - 0194
Chaidari

Greece
Local Institution - 0195
Holargos

Israel, Tel-Aviv
Local Institution - 0196
Tel Aviv

Israel
Local Institution - 0068
Beer Sheva

Israel
Local Institution - 0066
Haifa

Israel
Local Institution - 0067
Ramat Gan

Italy
Local Institution - 0064
Bari

Italy
Local Institution - 0193
Forlì

Italy
Local Institution - 0032
Milano

Italy
Local Institution - 0065
Modena

Italy
Local Institution - 0033
Padova

Italy
Local Institution - 0034
Pisa

Italy
Local Institution - 0035
Roma

Japan, Aichi
Local Institution - 0186
Komaki

Japan, Hokkaido
Local Institution - 0184
Sapporo

Japan, Hokkaido
Local Institution - 0177
Sapporo

Japan, Hokkaido
Local Institution - 0185
Sapporo

Japan, Ibaraki
Local Institution - 0179
Tsukuba-shi

Japan, Kagawa
Local Institution - 0171
Kita-gun

Japan, Kanagawa
Local Institution - 0169
Yokohama

Japan, Niigata
Local Institution - 0168
Niigata-shi

Japan, Osaka
Local Institution - 0173
Osakasayama

Japan, Osaka
Local Institution - 0175
Takatsuki City

Japan, Saitama
Local Institution - 0176
Hidaka-shi

Japan, Shizuoka
Local Institution - 0170
Hamamatsu-shi

Japan, Tokyo
Local Institution - 0178
Minato-ku

Japan, Tokyo
Local Institution - 0172
Shinjuku-ku

Japan
Local Institution - 0174
Fukuoka

Japan
Local Institution - 0180
Kyoto

Korea, Republic of, Gyeonggi-do
Local Institution - 0137
Goyang-si

Korea, Republic of, Gyeonggi-do
Local Institution - 0203
Seongnam-si

Korea, Republic of
Local Institution - 0220
Busan

Korea, Republic of
Local Institution - 0218
Daegu

Korea, Republic of
Local Institution - 0208
Gyeongsangnam-do

Korea, Republic of
Local Institution - 0215
Seongnam-si,

Korea, Republic of
Local Institution - 0140
Seoul

Korea, Republic of
Local Institution - 0136
Seoul

Korea, Republic of
Local Institution - 0211
Seoul

Korea, Republic of
Local Institution - 0138
Seoul

Mexico, BAJA Californa SUR
Local Institution - 0160
La Paz

Mexico, Distrito Federal
Local Institution
Df

Mexico, Jalisco
Local Institution - 0102
Zapopan

Mexico, Nuevo LEON
Local Institution - 0056
Monterrey

Mexico
Local Institution - 0105
Colima

Netherlands
Local Institution - 0070
Amsterdam

Netherlands
Local Institution - 0072
Groningen

Netherlands
Local Institution - 0073
Sittard-Geleen

New Zealand
Local Institution - 0087
Auckland

New Zealand
Local Institution - 0089
Christchurch

Norway
Local Institution - 0158
Gralum

Norway
Local Institution - 0132
Lorenskog

Norway
Local Institution - 0133
Oslo

Portugal
Local Institution - 0153
Lisboa

Portugal
Local Institution
Porto

Romania
Local Institution - 0219
Cluj-Napoca

Romania
Local Institution - 0076
Craiova

Romania
Local Institution - 0058
Sector 2

Russian Federation
Local Institution
Saint-Petersburg

Russian Federation
Local Institution
St Petersburg

Singapore
Local Institution - 0154
Singapore

Spain
Local Institution - 0113
Lugo

Spain
Local Institution - 0111
Madrid

Spain
Local Institution - 0112
Madrid

Spain
Local Institution - 0114
Madrid

Spain
Local Institution - 0156
Malaga

Spain
Local Institution - 0109
Sevilla

Taiwan
Local Institution - 0135
Kaohsiung

Taiwan
Local Institution - 0165
Taichung

Taiwan
Local Institution - 0141
Taipei City

Taiwan
Local Institution - 0139
Taipei

United Kingdom, Essex
Local Institution - 0128
Chelmsford

United Kingdom, Yorkshire
Local Institution - 0127
York

United Kingdom
Local Institution - 0122
Glasgow

United Kingdom
Local Institution - 0117
Lancaster

United Kingdom
Local Institution - 0121
London

United Kingdom
Local Institution - 0124
Oxford

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information