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Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer (CheckMate901)

  • Clinicaltrials.gov identifier

    NCT03036098

  • Recruitment Status

    Recruiting

  • First Posted

    January 30, 2017

  • Last update posted

    September 29, 2022

Study Description

Brief summary:

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

  • Condition or Disease:Urothelial Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Ipilimumab
    Drug: Gemcitabine
    Drug: Cisplatin
    Drug: Carboplatin
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 1307 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer
  • Actual Study Start Date: March 2017
  • Estimated Primary Completion Date: June 2023
  • Estimated Study Completion Date: July 2025

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: Investigational immunotherapy
Biological: Nivolumab
Specified Dose on Specified Days

Biological: Ipilimumab
Specified Dose on Specified Days
Experimental: Arm C: Investigational immunotherapy
Biological: Nivolumab
Specified Dose on Specified Days

Drug: Gemcitabine
Specified Dose on Specified Days

Drug: Cisplatin
Specified Dose on Specified Days
Active Comparator: Arm B: Standard of care chemotherapy
Drug: Gemcitabine
Specified Dose on Specified Days

Drug: Cisplatin
Specified Dose on Specified Days

Drug: Carboplatin
Specified Dose on Specified Days
Active Comparator: Arm D: Standard of care chemotherapy
Drug: Gemcitabine
Specified Dose on Specified Days

Drug: Cisplatin
Specified Dose on Specified Days

Outcome Measures

  • Primary Outcome Measures: 1. Overall survival (OS) in cisplatin-ineligible randomized participants [ Time Frame: Up to 55 months ]
  • 2. Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) [ Time Frame: Up to 52 months ]
  • 3. Progression-free survival (PFS) by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC [ Time Frame: Up to 64 months ]
  • 4. Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC [ Time Frame: Up to 64 months ]
  • Secondary Outcome Measures: 1. Overall survival (OS) in all randomized participants [ Time Frame: Up to 55 months ]
  • 2. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants [ Time Frame: Up to 55 months ]
  • 3. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in PD-L1 positive (≥1%) randomized participants [ Time Frame: Up to 55 months ]
  • 4. Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants [ Time Frame: Up to 55 months ]
  • 5. European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants [ Time Frame: Up to 55 months ]
  • 6. European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in cisplatin eligible participants with previously untreated, unresectable or metastatic UC [ Time Frame: Up to 64 months ]
  • 7. Progression-free survival (PFS) by BICR (using RECIST 1.1) by immunohistochemistry (IHC) [ Time Frame: Up to 64 months ]
  • 8. Overall survival (OS) by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC) [ Time Frame: Up to 64 months ]

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: Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Disease that is suitable for local therapy administered with curative intent Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply

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
Birmingham

United States, Alabama
Local Institution
Birmingham

United States, Alaska
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage

United States, Arkansas
Local Institution
Little Rock

United States, California
Local Institution - 0115
Fresno

United States, California
St Joseph Heritage Healthcare
Santa Rosa

United States, Florida
Local Institution - 0051
Boca Raton

United States, Florida
Local Institution - 0087
Fort Lauderdale

United States, Florida
Local Institution - 0062
Jacksonville

United States, Georgia
Local Institution - 0004
Athens

United States, Georgia
Local Institution - 0033
Thomasville

United States, Illinois
Local Institution - 0046
Chicago

United States, Iowa
Local Institution
Iowa City

United States, Louisiana
Local Institution - 0117
New Orleans

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Massachusetts
Local Institution - 0073
Boston

United States, Massachusetts
Milford Regional Medical Center
Boston

United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford

United States, Michigan
St. Joseph Mercy Hospital
Ypsilanti

United States, Minnesota
Local Institution - 0002
Burnsville

United States, Mississippi
Hattiesburg Clinic
Hattiesburg

United States, Missouri
Local Institution - 0032
Kansas City

United States, Missouri
Washington University School OF Medicine-Siteman Cancer Center
Saint Louis

United States, Nebraska
GU Research Network, LLC
Omaha

United States, New Hampshire
Local Institution - 0057
Manchester

United States, New Mexico
University Of New Mexico
Albuquerque

United States, New York
Local Institution - 0083
Buffalo

United States, New York
Local Institution - 0014
Mineola

United States, New York
Icahn School Of Medicine At Mount Sinai
New York

United States, New York
Local Institution
New York

United States, North Carolina
Local Institution - 0116
Durham

United States, Ohio
The Ohio State University
Columbus

United States, Oregon
Providence Portland Med Ctr
Portland

United States, Pennsylvania
Local Institution - 0013
Pittsburgh

United States, Texas
Local Institution
Houston

United States, Utah
Local Institution
Salt Lake City

United States, Washington
Local Institution - 0086
Kirkland

United States, Wisconsin
Local Institution
Milwaukee

Argentina, Buenos Aires
Local Institution - 0005
Capital Federal

Argentina, Buenos Aires
Local Institution - 0007
Mar Del Plata

Argentina, RIO Negro
Local Institution - 0008
Viedma

Argentina
Local Institution - 0009
Buenos Aires

Argentina
Local Institution - 0134
Cordoba

Argentina
Local Institution - 0006
Cordoba

Australia, New South Wales
Local Institution
Darlinghurst

Australia, New South Wales
Local Institution - 0096
Waratah

Australia, New South Wales
Local Institution - 0099
Westmead

Australia, Queensland
Local Institution - 0188
South Brisbane

Australia, Queensland
Local Institution - 0120
Tugun

Australia, Victoria
Local Institution - 0101
Heidelberg

Australia, Western Australia
Local Institution - 0100
Doubleview

Brazil, Distrito Federal
Local Institution - 0017
Brasilia

Brazil, RIO Grande DO SUL
Local Institution - 0021
Ijui

Brazil, RIO Grande DO SUL
Local Institution - 0119
Passo Fundo

Brazil, RIO Grande DO SUL
Local Institution - 0020
Porto Alegre

Brazil, Santa Catarina
Local Institution - 0016
Florianopolis

Brazil, Sao Paulo
Local Institution - 0018
Barretos

Brazil, Sao Paulo
Local Institution - 0019
Sao Jose Do Rio Preto

Brazil
Local Institution
Sao Paulo

Canada, Nova Scotia
Local Institution - 0053
Halifax

Canada, Ontario
Local Institution - 0064
London

Canada, Quebec
Local Institution - 0052
Sherbrooke

Canada
Local Institution - 0054
Quebec

Chile, Metropolitana
Local Institution - 0010
Santiago

Chile, Metropolitana
Local Institution
Santiago

Chile, Valparaiso
Local Institution - 0012
Vina del Mar

Chile
Local Institution - 0106
Vitacura

China, Beijing
Local Institution - 0171
Beijing

China, Beijing
Local Institution - 0169
Beijing

China, Chongqing
Local Institution - 0182
Chongqing

China, Guizhou
Local Institution
Guiyang

China, Heilongjiang
Local Institution - 0219
Harbin

China, Hubei
Local Institution - 0180
Wuhan

China, Jiangsu
Local Institution - 0177
Nanjing

China, Jiangsu
Local Institution - 0176
Nanjing

China, Jiangsu
Local Institution - 0175
Nanjng

China, Jilin
Local Institution - 0186
Changchun

China, Shan1xi
Local Institution - 0220
Taiyuan

China, Shandong
Local Institution - 0216
Yantai

China, Shanghai
Local Institution - 0167
Shanghai

China, Shanghai
Local Institution - 0162
Shanghai

China, Shanghai
Local Institution - 0163
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution - 0184
Chengdu

China, Zhejiang
Local Institution - 0174
Hangzhou

China, Zhejiang
Local Institution - 0172
Hangzhou

China, Zhejiang
Local Institution - 0173
Hangzhou

China
Local Institution - 0170
Beijing

China
Local Institution - 0164
Shanghai

Czechia
Local Institution - 0160
Brno

Czechia
Local Institution - 0152
Hradec Kralove

Denmark
Local Institution - 0190
Aalborg

Denmark
Local Institution - 0196
Herlev

Finland
Local Institution - 0060
Helsinki

France
Local Institution - 0089
Lille

France
Local Institution - 0088
Marseille Cedex 9

France
Local Institution - 0091
Nimes Cedex 09

France
Local Institution - 0090
St Priest En Jarez

France
Local Institution - 0092
Suresnes

France
Local Institution - 0093
Tours Cedex

France
Local Institution - 0094
Villejuif

Germany
Local Institution - 0036
Dresden

Germany
Local Institution - 0048
Essen

Germany
Local Institution - 0047
Freiburg

Germany
Local Institution - 0049
Hamburg

Germany
Local Institution - 0037
Hannover

Germany
Local Institution - 0041
Jena

Germany
Local Institution - 0213
Mannheim

Germany
Local Institution
Muenchen

Germany
Local Institution - 0038
Nuernberg

Germany
Local Institution - 0040
Tuebingen

Germany
Local Institution - 0114
Weiden

Germany
Local Institution - 0039
Wuerzburg

Greece
Local Institution - 0102
Athens

Greece
Local Institution - 0103
Ioannina

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Debrecen

Hungary
Local Institution
Miskolc

Israel
Local Institution - 0199
Kfar Saba

Israel
Local Institution - 0198
Ramat Gan

Italy
Local Institution - 0108
Arezzo

Italy
Local Institution - 0197
Faenza

Italy
Local Institution - 0111
Forlì

Italy
Local Institution - 0109
Grosseto

Italy
Local Institution - 0107
Milano

Italy
Local Institution - 0110
Napoli

Japan, Aomori
Local Institution - 0136
Hirosaki-shi

Japan, Chiba
Local Institution - 0135
Chiba-shi

Japan, Ehime
Local Institution - 0147
Matsuyama-shi

Japan, Fukuoka
Local Institution - 0140
Fukuoka-shi

Japan, Hokkaido
Local Institution - 0146
Sapporo-city

Japan, Ibaraki
Local Institution - 0150
Tsukuba-shi

Japan, Iwate
Local Institution - 0214
Morioka-shi

Japan, Kagawa
Local Institution - 0137
Kita-Gun

Japan, Niigata
Local Institution - 0141
Niigata-shi

Japan, Okayama
Local Institution - 0143
Okayama-shi

Japan, Osaka
Local Institution - 0144
Osaka-shi

Japan, Osaka
Local Institution - 0139
Osakasayama

Japan, Osaka
Local Institution - 0145
Takatsuki-shi

Japan, Shizuoka
Local Institution - 0201
Hamamatasu

Japan, Tokyo
Local Institution - 0149
Arakawa-ku,tokyo

Japan, Tokyo
Local Institution - 0148
Bunkyo-ku

Japan, Tokyo
Local Institution - 0142
Bunkyo-ku

Japan, Tokyo
Local Institution - 0138
Shinjuku-Ku

Japan, Wakayama
Local Institution - 0215
Wakayama-shi

Japan, Yamaguchi
Local Institution - 0200
Ube City

Korea, Republic of, Gyeonggido
Local Institution - 0125
Goyang-si

Korea, Republic of
Local Institution - 0126
Seongnam-si

Korea, Republic of
Local Institution - 0124
Seoul

Korea, Republic of
Local Institution - 0151
Seoul

Korea, Republic of
Local Institution - 0128
Seoul

Korea, Republic of
Local Institution - 0127
Seoul

Mexico, Distrito Federal
Local Institution - 0129
Ciudad de Mexico

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution - 0130
Tlalpan

Mexico, Nuevo Leon
Local Institution - 0131
Monterrey

Netherlands
Local Institution - 0022
Amsterdam

Netherlands
Local Institution - 0055
Enschede

Netherlands
Local Institution - 0024
Groningen

Netherlands
Local Institution - 0026
Leeuwarden

Norway
Local Institution - 0074
Bergen

Norway
Local Institution - 0081
Lorenskog

Peru
Local Institution - 0030
Lima

Peru
Local Institution - 0031
Lima

Poland
Local Institution - 0189
Bydgoszcz

Poland
Local Institution - 0205
Koszalin

Poland
Local Institution - 0202
Warszawa

Romania, Cluj
Local Institution - 0191
Cluj-Napoca

Romania
Local Institution - 0187
Craiova

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Local Institution
St Petersburg

Singapore
Local Institution - 0192
Singapore

Spain
Local Institution - 0070
A Coruna

Spain
Local Institution - 0068
Barcelona

Spain
Local Institution - 0065
Madrid

Spain
Local Institution - 0066
Madrid

Spain
Local Institution - 0209
Santander

Spain
Local Institution - 0067
Sevilla

Spain
Local Institution - 0069
Valencia

Sweden
Local Institution - 0075
Jonkoping

Sweden
Local Institution - 0059
Linkoping

Sweden
Local Institution - 0058
Lund

Switzerland
Local Institution - 0061
Baden

Switzerland
Local Institution - 0042
Chur

Taiwan
Local Institution - 0156
Kaohsiung

Taiwan
Local Institution - 0159
Taichung

Taiwan
Local Institution - 0158
Taipei

Taiwan
Local Institution - 0155
Taipei

Taiwan
Local Institution - 0157
Taoyuan

Turkey
Local Institution - 0194
Ankara

Turkey
Local Institution - 0204
Istanbul

Turkey
Local Institution - 0193
Izmir

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03036098 History of Changes
  • Other Study ID Numbers: CA209-901, 2016-003881-14
  • First Posted: January 30, 2017 Key Record Dates
  • Last Update Posted: September 29, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No