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A Study of Chemo Only Versus Chemo Plus Nivo With or Without BMS-986205, Followed by Post- Surgery Therapy With Nivo or Nivo and BMS-986205 in Patients With MIBC

  • Clinicaltrials.gov identifier

    NCT03661320

  • Recruitment Status

    Recruiting

  • First Posted

    September 7, 2018

  • Last update posted

    August 25, 2021

Study Description

Brief summary:

A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer (MIBC)

  • Condition or Disease:BMS-986205
    Muscle-Invasive Bladder Cancer
    Bladder Cancer
  • Intervention/Treatment: Drug: Cisplatin
    Drug: BMS-986205 Placebo
    Biological: Nivolumab
    Drug: BMS-986205
    Drug: Gemcitabine
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 1200 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: December 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Arm B
BMS-986205 Placebo + Nivolumab + Chemotherapy followed by BMS-986205 Placebo + Nivolumab post radical cystectomy
Biological: Nivolumab
Specified dose on specified day

Drug: Gemcitabine
Specified dose on specified day

Drug: Cisplatin
Specified dose on specified day

Drug: BMS-986205 Placebo
Specified dose on specified day
Experimental: Arm C
BMS-986205 + Nivolumab + Chemotherapy followed by Nivolumab plus BMS-986205 post radical cystectomy
Biological: Nivolumab
Specified dose on specified day

Drug: BMS-986205
Specified dose on specified day

Drug: Gemcitabine
Specified dose on specified day

Drug: Cisplatin
Specified dose on specified day
Active Comparator: Arm A
Chemotherapy alone followed by radical cystectomy
Drug: Gemcitabine
Specified dose on specified day

Drug: Cisplatin
Specified dose on specified day

Outcome Measures

  • Primary Outcome Measures: 1. Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approx. 39 months ]
    Comparison of Arm B to Arm A; and Comparison of Arm C to Arm A
  • 2. Event-Free Survival (EFS), in all randomized participants [ Time Frame: Approx. 57 months ]
    Comparison of Arm B to Arm A; and Comparison of Arm C to Arm A;
  • Secondary Outcome Measures: 1. Overall Survival (OS) in all randomized participants [ Time Frame: Approx. 76 months ]
    Comparison of Arm C vs Arm A; and Comparison of Arm B vs Arm A
  • 2. Incidence of Adverse Events (AE) in all treated participants [ Time Frame: Approx. 76 months ]
  • 3. Incidence of Serious Adverse Events (SAE) in all treated participants [ Time Frame: Approx. 76 months ]
  • 4. Incidence of Laboratory abnormalities in all treated participants [ Time Frame: Approx. 76 months ]
  • 5. Incidence of death in all treated participants [ Time Frame: Approx. 76 months ]
  • 6. Pathological Complete Response (pCR) rate, in all randomized participants [ Time Frame: Approx. 39 months ]
    Comparison of Arm B v Arm C
  • 7. Event Free Survival (EFS), in all randomized participants [ Time Frame: Approx. 57 months ]
    Comparison of Arm B v Arm C

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: - Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if there is a predominant urothelial component. - 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 LN (≥ 10 mm in short axis) or metastatic bladder cancer - Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is also not permitted - Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured (24-hour urine) creatinine clearance (CrCl) < 50 mL/min

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com

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

Locations

Japan
Local Institution
Kyoto

Japan, Aichi
Local Institution
Komaki

Japan, Hokkaido
Local Institution
Sapporo

Japan, Hokkaido
Local Institution
Sapporo

Japan, Hokkaido
Local Institution
Sapporo

Japan, Ibaraki
Local Institution
Tsukuba-shi

Japan, Kagawa
Local Institution
Kita-gun

Japan, Kanagawa
Local Institution
Yokohama

Japan, Niigata
Local Institution
Niigata-shi

Japan, Osaka
Local Institution
Osakasayama

Japan, Osaka
Local Institution
Takatsuki City

Japan, Saitama
Local Institution
Hidaka-shi

Japan, Shizuoka
Local Institution
Hamamatsu-shi

Japan, Tokyo
Local Institution
Minato-ku

Japan, Tokyo
Local Institution
Shinjuku-ku

Japan
Local Institution
Fukuoka

United States, California
Local Institution
San Jose

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
Local Institution
Orange

United States, California
UC Davis Comprehensive Cancer Center
Sacramento

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
H. Lee Moffitt Cancer Center
Tampa

United States, Georgia
Northside Hospital
Atlanta

United States, Illinois
The University Of Chicago
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
University of Minnesota
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
Northwell Health
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
Instituto Medico Especializado Alexander Fleming
Capital Federal

Argentina, Buenos Aires
Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires

Argentina, Distrito Federal
Hospital Aleman
Ciudad Autonoma Buenos Aires

Australia, Australian Capital Territory
Local Institution
Garran

Australia, New South Wales
Local Institution
Kingswood

Australia, New South Wales
Macquarie University
Macquarie University

Australia, New South Wales
Northern Cancer institute
St Leonards

Australia, South Australia
Calvary Hospital
North Adelaide

Australia, Victoria
Austin Hospital
Heidelberg

Australia, Western Australia
St John of God Murdoch Hospital
Murdoch

Austria
Klinikum Klagenfurt Am Woerthersee
Klagenfurt Am Woerthersee

Austria
Universitaetsklinikum Krems
Krems

Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz

Austria
AKH Allgemeines Krankenhaus Wien
Wien

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Gent

Belgium
Local Institution
Leuven

Belgium
Local Institution
Wilrijk

Brazil, Ceara
Oncocentro Servico Medicos e Hospitalares Ltda
Fortaleza

Brazil, Minas Gerais
Hospital Marcio Cunha
Ipatinga

Brazil, RIO Grande DO SUL
Associacao Hospital de Caridade Ijui
Ijui

Brazil, RIO Grande DO SUL
Hospital Moinhos de Vento
Porto Alegre

Brazil, Rio Grande Do Sul
Hospital Sao Lucas Da Pucrs
Porto Alegre

Brazil, Sao Paulo
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos

Brazil, Sao Paulo
Fundacao Doutor Amaral Carvalho
Jau

Brazil, Sao Paulo
Hospital De Base Da Faculdade De Medicina De Rio Preto
Sao Jose Do Rio Preto

Brazil
Inca - Instituto Nacional Do Cancer
Rio De Janeiro

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Canada, British Columbia
Local Institution
Abbotsford

Canada, British Columbia
Local Institution
Kelowna

Canada, Ontario
Local Institution
North York

Canada, Quebec
Local Institution
Chicoutimi

Canada, Quebec
Local Institution
Montreal

Chile, Metropolitana
Pontificia Universidad Catolica de Chile
Santiago

Chile, Metropolitana
Hospital Clinico de la Universidad De Chile
Santiago

Chile, Metropolitana
Centro de Investigacion Clinica Bradford Hill
Santiago

Chile, Metropolitana
Fundacion Arturo Lopez Perez
Santiago

Colombia, Bogota
Local Institution
Colombia

Colombia
Foscal Internacional
Bucaramanga

Colombia
Oncomedica S.A.
Monteria

Denmark
Local Institution
?lborg

Denmark
Local Institution
Arhus

Denmark
Local Institution
Herlev

Finland
Local Institution
Helsinki

Finland
Local Institution
Tampere

Finland
Local Institution
Turku

France, Cedex
Hopital Morvan
Brest

France
CHU Amiens - Picardie
Amiens

France
Chu Angers
Angers

France
Chu Jean Minjoz
Besancon Cedex

France
Local Institution
Bordeaux

France
Institut Bergonie
Bordeaux

France
Centre Jean Perrin
Clermont-ferrand

France
Chu Henri Mondor
Creteil Cedex

France
CHU Michallon
La Tronche

France
Hopital Prive CLAIRVAL
Marseille

France
Institut du Cancer de Montpellier
Montpellier Cedex 5

France
Centre Antoine Lacassagne
Nice

France
Institut Mutualiste Montsouris
Paris

France
Centre Hospitalier Lyon Sud
Pierre Benite

France
Local Institution
Rennes Cedex

France
Centre Rene Gauducheau
Saint Herblain Cedex

France
ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg Cedex

France
Institut Claudius Regaud
TOULOUSE Cedex 9

Germany
Universitaetsklinikum Aachen
Aachen

Germany
Helios Klinikum Erfurt
Erfurt

Germany
Klinik Essen-Mitte
Essen

Germany
Johann Wolfgang Goethe Universitaet
Frankfurt Main

Germany
Universitaetsmedizin Goettingen
Goettingen

Germany
Local Institution
Heidelberg

Germany
Marien Hospital Herne
Herne

Germany
Universitaetsklinikum Jena
Jena

Germany
University Hospital Schleswig-Holstein
Luebeck

Germany
Universitaetsklinikum Magdeburg
Magdeburg

Germany
Universitaetsmedizin Der Johannes Gutenberg-Universitaet
Mainz

Germany
Klinikum rechts der Isar der TU
Muenchen

Germany
Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg

Germany
Krankenhaus der Barmherzigen Brueder
Trier

Greece
Local Institution
Athens

Greece
University General Hospital of Athens Attikon
Chaidari

Greece
Metropolitan General Hospital
Holargos

Greece
University General Hospital of Larissa
Larissa

Israel
Local Institution
Beer Sheva

Israel
Local Institution
Haifa

Israel
Local Institution
Ramat Gan

Israel
Local Institution
Tel Aviv

Italy
IRCCS Giovanni Paolo II Istituto Oncologico
Bari

Italy
Local Institution
Forlì

Italy
IRCCS Istituto Nazionale Tumori Milano
Milano

Italy
Ospedale Di Carpi
Modena

Italy
Istituto Oncologico Veneto IOV
Padova

Italy
Azienda Ospedaliera Universitaria Pisana
Pisa

Italy
Fondazione Policlinico Universitario A. Gemelli
Roma

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

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

Korea, Republic of
Local Institution
Busan

Korea, Republic of
Local Institution
Daegu

Korea, Republic of
Local Institution
Gyeongsangnam-do

Korea, Republic of
Local Institution
Seongnam-si,

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Mexico, BAJA Californa SUR
Local Institution
La Paz

Mexico, Distrito Federal
Local Institution
Df

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico
Local Institution
Colima

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Groningen

Netherlands
Local Institution
Sittard-Geleen

New Zealand
Local Institution
Auckland

New Zealand
Local Institution
Christchurch

Norway
Local Institution
Gralum

Norway
Local Institution
Lorenskog

Norway
Local Institution
Oslo

Portugal
Local Institution
Lisboa

Portugal
Local Institution
Porto

Romania
Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
Bucharest

Romania
Local Institution
Cluj-Napoca

Romania
Sf. Nectarie Oncology Center
Craiova

Russian Federation
Local Institution
Saint-Petersburg

Russian Federation
Local Institution
St Petersburg

Singapore
Local Institution
Singapore

Spain
Local Institution
Lugo

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Malaga

Spain
Local Institution
Sevilla

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taipei City

Taiwan
Local Institution
Taipei

United Kingdom, Essex
Local Institution
Chelmsford

United Kingdom, Yorkshire
Local Institution
York

United Kingdom
Local Institution
Glasgow

United Kingdom
Local Institution
Lancaster

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Oxford

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03661320 History of Changes
  • Other Study ID Numbers: CA017-078, 2017-004692-31
  • First Posted: September 7, 2018 Key Record Dates
  • Last Update Posted: August 25, 2021
  • Last Verified: August 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Urinary Bladder Neoplasms