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


Condition: Urothelial Cancer

Intervention:

  • Biological: nivolumab
  • Biological: ipilimumab
  • Drug: gemcitabine
  • Drug: cisplatin
  • Drug: carboplatin

Purpose: 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 patients with previously untreated inoperable or metastatic urothelial cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03036098

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Overall survival (OS) in cisplatin-ineligible randomized participants
  • Time Frame: Up to 55 months
  • Safety Issue:
  • Measure: OS in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC)
  • Time Frame: Up to 52 months
  • Safety Issue:
  • Measure: PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-eligible participants with previously untreated, unresectable or metastatic Urothelial Carcinoma( UC)
  • Time Frame: Up to 55 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival (OS) in all randomized participants
  • Time Frame: Up to 55 months
  • Safety Issue:
  • Measure: PFS by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (≥1%) randomized participants and in all randomized participants
  • Time Frame: Up to 55 months
  • Safety Issue:
  • Measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Global Health Status score in all randomized participants
  • Time Frame: Up to 55 months
  • Safety Issue:
  • Measure: OS in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC.
  • Time Frame: Up to 55 months
  • Safety Issue:
  • Measure: European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score
  • Time Frame: Up to 55 months
  • Safety Issue:
  • Measure: PFS in PD-L1 positive by BICR (using RECIST 1.1)
  • Time Frame: Up to 55 months
  • Safety Issue:
  • Measure: OS by PD-L1 expression at ≥ 1% expression by immunohistochemistry (IHC)
  • Time Frame: Up to 55 months
  • Safety Issue:

Estimated Enrollment: 990

Study Start Date: March 24, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Metastatic or inoperable urothelial cancer
  • Must have at least 1 lesion with measurable disease
  • Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
  • No prior systemic chemotherapy treatment in the metastatic setting Exclusion Criteria:
  • Patients with disease that is suitable for local therapy administered with curative intent
  • Patients with active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol defined inclusion/

Exclusion Criteria:

  • Patients with disease that is suitable for local therapy administered with curative intent
  • Patients with active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol defined inclusion/exclusion criteria could apply

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email:

Locations:

  • Local Institution
  • Birmingham Alabama 35223 United States
  • Local Institution
  • Birmingham Alabama 35233 United States
  • Alaska Urological Institute dba Alaska Clinical Research Center
  • Anchorage Alaska 99503 United States
  • Local Institution
  • Little Rock Arkansas 72205 United States
  • VA of Central California Health Care System
  • Fresno California 93703 United States
  • St Joseph Heritage Healthcare
  • Santa Rosa California 95403 United States
  • Boca Raton Regional Hospital
  • Boca Raton Florida 33486 United States
  • Holy Cross Hospital
  • Fort Lauderdale Florida 33308 United States
  • Cancer Specialists of North FL
  • Jacksonville Florida 32207 United States
  • University Cancer Blood Ctr
  • Athens Georgia 30607 United States
  • Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
  • Thomasville Georgia 31792 United States
  • University Of Illinois At Chicago
  • Chicago Illinois 60612 United States
  • Local Institution
  • Iowa City Iowa 55242 United States
  • Ochsner Clinic
  • New Orleans Louisiana 70121 United States
  • Beth Israel Deaconess Med Ctr
  • Boston Massachusetts 02215 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Milford Regional Medical Center
  • Boston Massachusetts 02215 United States
  • South Shore Hospital Cancer Center
  • Boston Massachusetts 02215 United States
  • St. Joseph Mercy Hospital
  • Ypsilanti Michigan 48197 United States
  • Ridges Cancer Clinic
  • Burnsville Minnesota 55337 United States
  • Hattiesburg Clinic
  • Hattiesburg Mississippi 39401 United States
  • St Lukes Hospital
  • Kansas City Missouri 64111 United States
  • Washington University School OF Medicine-Siteman Cancer Center
  • Saint Louis Missouri 63110 United States
  • GU Research Network, LLC
  • Omaha Nebraska 68130 United States
  • NH Oncology-Hematology, PA
  • Hooksett New Hampshire 03106 United States
  • University Of New Mexico
  • Albuquerque New Mexico 87131 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263 United States
  • NYU Winthrop Hospital Dept of Oncology/Hematology
  • Mineola New York 11501 United States
  • Icahn School Of Medicine At Mount Sinai
  • New York New York 10029 United States
  • Local Institution
  • New York New York 10065 United States
  • Duke University Medical Center
  • Durham North Carolina 27710 United States
  • The Ohio State University
  • Columbus Ohio 43210 United States
  • Providence Portland Med Ctr
  • Portland Oregon 97213 United States
  • Allegheny General Hospital
  • Pittsburgh Pennsylvania 15212 United States
  • Local Institution
  • Houston Texas 77030 United States
  • Local Institution
  • Salt Lake City Utah 84112 United States
  • Seattle Cancer Care Alliance
  • Kirkland Washington 98034 United States
  • Local Institution
  • Milwaukee Wisconsin 53226 United States
  • Instituto Medico Especializado Alexander Fleming
  • Capital Federal Buenos Aires 1426 Argentina
  • Hospital Privado De Comunidad
  • Mar Del Plata Buenos Aires 7600 Argentina
  • Clinica Viedma S.A.
  • Viedma RIO Negro 8500 Argentina
  • Centro De Diagnostico Urologico S.R.L.
  • Buenos Aires 1120 Argentina
  • Instituto Oncologico De Cordoba
  • Cordoba 5000 Argentina
  • Clinica Privada Universitaria Reina Fabiola
  • Cordoba 5004 Argentina
  • Local Institution
  • Darlinghurst New South Wales 2010 Australia
  • Local Institution
  • Waratah New South Wales 2298 Australia
  • Local Institution
  • Westmead New South Wales 2145 Australia
  • Local Institution
  • South Brisbane Queensland 4101 Australia
  • Local Institution
  • Tugan Queensland 4224 Australia
  • Local Institution
  • Heidelberg Victoria 3084 Australia
  • Local Institution
  • Nedlands Western Australia 6009 Australia
  • Hospital Sirio Libanes
  • Brasilia Distrito Federal 70200-730 Brazil
  • Associacao Hospital de Caridade Ijui
  • Ijui RIO Grande DO SUL 98700-000 Brazil
  • Hospital Sao Vicente De Paulo
  • Passo Fundo RIO Grande DO SUL 99010-080 Brazil
  • Hospital Sao Lucas Da Pucrs
  • Porto Alegre RIO Grande DO SUL 90610-000 Brazil
  • Centro de Pesquisas Oncologicas de Santa Catarina-CEPON
  • Florianopolis Santa Catarina 88034-000 Brazil
  • Fundacao Pio Xii Hosp Cancer De Barretos
  • Barretos SAO Paulo 14784-400 Brazil
  • Hospital De Base Da Faculdade De Medicina De Rio Preto
  • Sao Jose Do Rio Preto SAO Paulo 15090-000 Brazil
  • Local Institution
  • Sao Paulo 01509-900 Brazil
  • Nova Scotia Health Authority QEII Health Sciences Centre
  • Halifax Nova Scotia B3H 2Y9 Canada
  • London Regional Cancer Program, London Health Sciences Centre
  • London Ontario N6A 4L6 Canada
  • Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
  • Sherbrooke Quebec J1H 5N4 Canada
  • CHU de Quebec - L'Hotel-Dieu de Quebec
  • Quebec G1R 2J6 Canada
  • Local Institution
  • Santiago Metropolitana Chile
  • Centro Internacional de Estudios Clinicos
  • Recoleta Santiago DE Chile Chile
  • Oncocentro Apys
  • Vina del Mar Valparaiso 2520598 Chile
  • Local Institution
  • Vitacura Chile
  • Local Institution
  • Beijing Beijing 100001 China
  • Local Institution
  • Beijing Beijing 100034 China
  • Local Institution
  • Chongqing Chongqing 400030 China
  • Local Institution
  • Wuhan Hubei 430030 China
  • Local Institution
  • Nanjing Jiangsu 210000 China
  • Local Institution
  • Nanjing Jiangsu 210008 China
  • Local Institution
  • Nanjng Jiangsu China
  • Local Institution
  • Changchun Jilin 130021 China
  • Local Institution
  • Shanghai Shanghai 200025 China
  • Local Institution
  • Shanghai Shanghai 200032 China
  • Local Institution
  • Shanghai Shanghai 200040 China
  • Local Institution
  • Chengdu Sichuan 610041 China
  • Local Institution
  • Hangzhou Zhejiang 310009 China
  • Local Institution
  • Hangzhou Zhejiang 310014 China
  • Local Institution
  • Beijing 100083 China
  • Local Institution
  • Hangzhou 310022 China
  • Local Institution
  • Shanghai 200032 China
  • Klinika komplexni onkologicke pece
  • Brno 656 53 Czechia
  • Klinika onkologie a radioterapie
  • Hradec Kralove 500 05 Czechia
  • Local Institution
  • Aalborg 9100 Denmark
  • Local Institution
  • Herlev 2730 Denmark
  • Local Institution
  • Helsinki 00029 Finland
  • Local Institution
  • Lille 59000 France
  • Local Institution
  • Marseille Cedex 9 13273 France
  • Local Institution
  • Nimes Cedex 09 30029 France
  • Local Institution
  • Saint Priest En Jarez 42271 France
  • Local Institution
  • Suresnes 92151 France
  • Local Institution
  • Tours Cedex 37044 France
  • Local Institution
  • Villejuif 94805 France
  • Universitat Dresden
  • Dresden 01307 Germany
  • Universitaetsklinikum Essen
  • Essen 45147 Germany
  • Medizinische Universitaetsklinik Freiburg
  • Freiburg 79106 Germany
  • Asklepios Klinik Altona
  • Hamburg 22763 Germany
  • Medizinische Hochschule Hannover
  • Hannover 30625 Germany
  • Universitaetsklinikum Jena
  • Jena 07747 Germany
  • Universitaetsklinikum Mannheim
  • Mannheim 68167 Germany
  • Local Institution
  • Muenchen 81675 Germany
  • Klinikum Nuernberg Nord, Urologische Klinik
  • Nuernberg 90419 Germany
  • Uniklinik Tuebingen
  • Tuebingen 72076 Germany
  • Kliniken Nordoberpfalz AG
  • Weiden 92637 Germany
  • Univ. Klinikum Wuerzburg
  • Wuerzburg 97080 Germany
  • Alexandra General Hospital
  • Athens 11528 Greece
  • Ioannina University Hospital
  • Ioannina 45500 Greece
  • Local Institution
  • Budapest 1122 Hungary
  • Local Institution
  • Budapest 1145 Hungary
  • Local Institution
  • Debrecen Hungary
  • Local Institution
  • Miskolc 3526 Hungary
  • Local Institution
  • Kfar Saba 44281 Israel
  • Local Institution
  • Ramat Gan 52621 Israel
  • Ospedale S. Donato - Usl 8
  • Arezzo 52100 Italy
  • Ospedale Per Gli Infermi
  • Faenza 48018 Italy
  • IRST Meldola
  • Forli 47014 Italy
  • Ospedale Della Misericordia Grosseto
  • Grosseto 58100 Italy
  • IRCCS Istituto Nazionale Tumori Milano
  • Milano 20133 Italy
  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
  • Napoli 80131 Italy
  • Local Institution
  • Hirosaki-shi Aomori 036-8563 Japan
  • Local Institution
  • Chiba-shi Chiba 260-8717 Japan
  • Local Institution
  • Matsuyama-shi Ehime 7910280 Japan
  • Local Institution
  • Fukuoka-shi Fukuoka 8128582 Japan
  • Local Institution
  • Sapporo-city Hokkaido 0608543 Japan
  • Local Institution
  • Tsukuba-shi Ibaraki 3058576 Japan
  • Local Institution
  • Morioka-shi Iwate 0208505 Japan
  • Local Institution
  • Kita-Gun Kagawa 7610793 Japan
  • Local Institution
  • Niigata-shi Niigata 9518520 Japan
  • Local Institution
  • Okayama-shi Okayama 7008558 Japan
  • Local Institution
  • Osaka-shi Osaka 5418567 Japan
  • Local Institution
  • Osakasayama Osaka 589-8511 Japan
  • Local Institution
  • Takatsuki-shi Osaka 5698686 Japan
  • Local Institution
  • Hamamatsu-shi Shizuoka 431-3192 Japan
  • Local Institution
  • Arakawa-ku,tokyo Tokyo 1168567 Japan
  • Local Institution
  • Bunkyo-ku Tokyo 1138519 Japan
  • Local Institution
  • Bunkyo-ku Tokyo 1138602 Japan
  • Local Institution
  • Shinjuku-Ku Tokyo 1608582 Japan
  • Local Institution
  • Wakayama-shi Wakayama 6418510 Japan
  • Local Institution
  • Ube City Yamaguchi 755-8505 Japan
  • Local Institution
  • Goyang-si 10408 Korea, Republic of
  • Local Institution
  • Seongnam-si 13620 Korea, Republic of
  • Local Institution
  • Seoul 03080 Korea, Republic of
  • Local Institution
  • Seoul 03722 Korea, Republic of
  • Local Institution
  • Seoul 05505 Korea, Republic of
  • Local Institution
  • Seoul 06351 Korea, Republic of
  • Comite Mexicano para la Prevenion de la Osteoporosis A.C.
  • Ciudad de Mexico Distrito Federal 06100 Mexico
  • Hospital Juarez De Mexico
  • Mexico City Distrito Federal 07760 Mexico
  • Instituto Nacional De Cancerologia
  • Tlalpan Distrito Federal 14080 Mexico
  • Centro Universitario Contra el Cancer UANL
  • Monterrey Nuevo LEON 64460 Mexico
  • Local Institution
  • Amsterdam 1066 CX Netherlands
  • Local Institution
  • Enschede 7512KZ Netherlands
  • Local Institution
  • Groningen 9713 GZ Netherlands
  • Local Institution
  • Leeuwarden 8934 AD Netherlands
  • Local Institution
  • Bergen 5021 Norway
  • Local Institution
  • Lorenskog 1478 Norway
  • Instituto Nacional De Enfermedades Neoplasicas
  • Lima 34 Peru
  • Clinica El Golf
  • Lima Lima 27 Peru
  • Ambulatorium Chemioterapii
  • Bydgoszcz 85-796 Poland
  • Oddzial Dzienny Chemioterapii
  • Koszalin 75-581 Poland
  • Klinika Nowotworow Ukladu Moczowego Centrum Onkologii - Inst
  • Warszawa 02-781 Poland
  • Local Institution
  • Cluj-Napoca 400015 Romania
  • Local Institution
  • Craiova 200347 Romania
  • Local Institution
  • Moscow 115478 Russian Federation
  • Local Institution
  • Moscow 117997 Russian Federation
  • Local Institution
  • Moscow 125367 Russian Federation
  • Local Institution
  • Novosibirsk 630099 Russian Federation
  • Local Institution
  • St Petersburg 198255 Russian Federation
  • Local Institution
  • Singapore 169610 Singapore
  • Comp. Hosp. Univ. A Coruna
  • A Coruna 15006 Spain
  • Hospital Santa Creu I Sant Pau
  • Barcelona 08025 Spain
  • Hospital Universitario Ramon Y Cajal
  • Madrid 28034 Spain
  • Hosp Univer 12 De Octubre
  • Madrid 28041 Spain
  • H. U. Marques de Valdecilla
  • Santander 39008 Spain
  • Hosp. Univ. Virgen Del Rocio
  • Sevilla 41013 Spain
  • Instituto Valenciano De Oncologia
  • Valencia 46009 Spain
  • Local Institution
  • Jonkoping 551 85 Sweden
  • Local Institution
  • Linkoping 581 85 Sweden
  • Local Institution
  • Lund 221 85 Sweden
  • Kantonsspital Baden
  • Baden 5404 Switzerland
  • Kantonsspital Graubuenden
  • Chur 7000 Switzerland
  • Local Institution
  • Kaohsiung 883 Taiwan
  • Local Institution
  • Taichung 40705 Taiwan
  • Local Institution
  • Taipei 100 Taiwan
  • Local Institution
  • Taipei 11217 Taiwan
  • Local Institution
  • Taoyuan 333 Taiwan
  • Local Institution
  • Ankara 06590 Turkey
  • Local Institution
  • Istanbul 34300 Turkey
  • Local Institution
  • Izmir 35340 Turkey

View trial on ClinicalTrials.gov


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