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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

    October 18, 2021

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: 897 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer
  • Actual Study Start Date: March 2017
  • Estimated Primary Completion Date: March 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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: 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

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
VA of Central California Health Care System
Fresno

United States, California
Local Institution
Santa Rosa

United States, Florida
Boca Raton Regional Hospital
Boca Raton

United States, Florida
Holy Cross Hospital
Fort Lauderdale

United States, Florida
Cancer Specialists of North FL
Jacksonville

United States, Georgia
University Cancer Blood Ctr
Athens

United States, Georgia
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville

United States, Illinois
University Of Illinois At Chicago
Chicago

United States, Iowa
Local Institution
Iowa City

United States, Louisiana
Ochsner Clinic
New Orleans

United States, Massachusetts
Dana Farber Cancer Institute-Parent Account
Boston

United States, Massachusetts
Dana Farber Cancer Institute
Boston

United States, Massachusetts
Milford Regional Medical Center
Boston

United States, Massachusetts
South Shore Hospital Cancer Center
Boston

United States, Michigan
St. Joseph Mercy Hospital
Ypsilanti

United States, Minnesota
Ridges Cancer Clinic
Burnsville

United States, Mississippi
Hattiesburg Clinic
Hattiesburg

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
NH Oncology-Hematology, PA
Manchester

United States, New Mexico
University Of New Mexico
Albuquerque

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, New York
NYU Winthrop Hospital Dept of Oncology/Hematology
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
Duke University Medical Center
Durham

United States, Ohio
The Ohio State University
Columbus

United States, Oregon
Providence Portland Med Ctr
Portland

United States, Pennsylvania
St Lukes Hospital
Easton

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh

United States, Texas
Local Institution
Houston

United States, Utah
Local Institution
Salt Lake City

United States, Washington
Seattle Cancer Care Alliance
Kirkland

United States, Wisconsin
Local Institution
Milwaukee

Argentina, Buenos Aires
Instituto Medico Especializado Alexander Fleming
Capital Federal

Argentina, Buenos Aires
Hospital Privado De Comunidad
Mar Del Plata

Argentina, RIO Negro
Clinica Viedma S.A.
Viedma

Argentina
Centro De Diagnostico Urologico S.R.L.
Buenos Aires

Argentina
Instituto Oncologico De Cordoba
Cordoba

Argentina
Clinica Universitaria Reina Fabiola
Cordoba

Australia, New South Wales
Local Institution
Darlinghurst

Australia, New South Wales
Local Institution
Waratah

Australia, New South Wales
Local Institution
Westmead

Australia, Queensland
Local Institution
South Brisbane

Australia, Queensland
Local Institution
Tugun

Australia, Victoria
Local Institution
Heidelberg

Australia, Western Australia
Local Institution
Nedlands

Brazil, Distrito Federal
Hospital Sirio Libanes
Brasilia

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

Brazil, RIO Grande DO SUL
Hospital Sao Vicente De Paulo
Passo Fundo

Brazil, RIO Grande DO SUL
Hospital Sao Lucas Da Pucrs
Porto Alegre

Brazil, Santa Catarina
Centro de Pesquisas Oncologicas de Santa Catarina-CEPON
Florianopolis

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

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

Brazil
Local Institution
Sao Paulo

Canada, Nova Scotia
Nova Scotia Health Authority QEII Health Sciences Centre
Halifax

Canada, Ontario
London Regional Cancer Program, London Health Sciences Centre
London

Canada, Quebec
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke

Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec

Chile, Metropolitana
Centro Internacional de Estudios Clinicos
Recoleta

Chile, Metropolitana
Local Institution
Santiago

Chile, Valparaiso
Oncocentro Apys
Vina del Mar

Chile
Local Institution
Vitacura

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Chongqing
Local Institution
Chongqing

China, Guizhou
Local Institution
Guiyang

China, Heilongjiang
Local Institution
Harbin

China, Hubei
Local Institution
Wuhan

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nanjng

China, Jilin
Local Institution
Changchun

China, Shan1xi
Local Institution
Taiyuan

China, Shandong
Local Institution
Yantai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Hangzhou

China
Local Institution
Beijing

China
Local Institution
Shanghai

Czechia
Klinika komplexni onkologicke pece
Brno

Czechia
Klinika onkologie a radioterapie
Hradec Kralove

Denmark
Local Institution
Aalborg

Denmark
Local Institution
Herlev

Finland
Local Institution
Helsinki

France
Local Institution
Lille

France
Local Institution
Marseille Cedex 9

France
Local Institution
Nimes Cedex 09

France
Local Institution
Saint Priest En Jarez

France
Local Institution
Suresnes

France
Local Institution
Tours Cedex

France
Local Institution
Villejuif

Germany
Universitat Dresden
Dresden

Germany
Universitaetsklinikum Essen
Essen

Germany
Medizinische Universitaetsklinik Freiburg
Freiburg

Germany
Asklepios Klinik Altona
Hamburg

Germany
Medizinische Hochschule Hannover
Hannover

Germany
Universitaetsklinikum Jena
Jena

Germany
Universitaetsklinikum Mannheim
Mannheim

Germany
Local Institution
Muenchen

Germany
Klinikum Nuernberg Nord, Urologische Klinik
Nuernberg

Germany
Uniklinik Tuebingen
Tuebingen

Germany
Kliniken Nordoberpfalz AG
Weiden

Germany
Univ. Klinikum Wuerzburg
Wuerzburg

Greece
Alexandra General Hospital
Athens

Greece
Ioannina University Hospital
Ioannina

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Debrecen

Hungary
Local Institution
Miskolc

Israel
Local Institution
Kfar Saba

Israel
Local Institution
Ramat Gan

Italy
Ospedale S. Donato - Usl 8
Arezzo

Italy
Ospedale Per Gli Infermi
Faenza

Italy
IRST Meldola
Forlì

Italy
Ospedale Della Misericordia Grosseto
Grosseto

Italy
IRCCS Istituto Nazionale Tumori Milano
Milano

Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Napoli

Japan, Aomori
Local Institution
Hirosaki-shi

Japan, Chiba
Local Institution
Chiba-shi

Japan, Ehime
Local Institution
Matsuyama-shi

Japan, Fukuoka
Local Institution
Fukuoka-shi

Japan, Hokkaido
Local Institution
Sapporo-city

Japan, Ibaraki
Local Institution
Tsukuba-shi

Japan, Iwate
Local Institution
Morioka-shi

Japan, Kagawa
Local Institution
Kita-Gun

Japan, Niigata
Local Institution
Niigata-shi

Japan, Okayama
Local Institution
Okayama-shi

Japan, Osaka
Local Institution
Osaka-shi

Japan, Osaka
Local Institution
Osakasayama

Japan, Osaka
Local Institution
Takatsuki-shi

Japan, Shizuoka
Local Institution
Hamamatsu-shi

Japan, Tokyo
Local Institution
Arakawa-ku,tokyo

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Shinjuku-Ku

Japan, Wakayama
Local Institution
Wakayama-shi

Japan, Yamaguchi
Local Institution
Ube City

Korea, Republic of
Local Institution
Goyang-si

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, Distrito Federal
Local Institution
Ciudad de Mexico

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution
Tlalpan

Mexico, Nuevo Leon
Local Institution
Monterrey

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Enschede

Netherlands
Local Institution
Groningen

Netherlands
Local Institution
Leeuwarden

Norway
Local Institution
Bergen

Norway
Local Institution
Lorenskog

Peru
Instituto Nacional De Enfermedades Neoplasicas
Lima

Peru
Clinica El Golf
Lima

Poland
Ambulatorium Chemioterapii
Bydgoszcz

Poland
Oddzial Dzienny Chemioterapii
Koszalin

Poland
Klinika Nowotworow Ukladu Moczowego
Warszawa

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
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
Singapore

Spain
Comp. Hosp. Univ. A Coruna
A Coruna

Spain
Hospital Santa Creu I Sant Pau
Barcelona

Spain
Hospital Universitario Ramon Y Cajal
Madrid

Spain
Hosp Univer 12 De Octubre
Madrid

Spain
H. U. Marques de Valdecilla
Santander

Spain
Hospital Universitario Virgen Del Rocio
Sevilla

Spain
Instituto Valenciano De Oncologia
Valencia

Sweden
Local Institution
Jonkoping

Sweden
Local Institution
Linkoping

Sweden
Local Institution
Lund

Switzerland
Kantonsspital Baden
Baden

Switzerland
Kantonsspital Graubuenden
Chur

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taoyuan

Turkey
Local Institution
Ankara

Turkey
Local Institution
Istanbul

Turkey
Local Institution
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: October 18, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No