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
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03036098 Recruiting January 30, 2017 June 16, 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
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: November 2022
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 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 Center, LLC 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 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 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 Local Institution - 0057 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 Local Institution - 0116 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 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 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 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 Universitat Dresden 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 Ube City
Korea, Republic of 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 Enschede
Netherlands Local Institution - 0024 Groningen
Netherlands Local Institution - 0026 Leeuwarden
Norway Local Institution 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 Linkoping
Sweden Local Institution 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
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT03036098     
Other Study ID Numbers : CA209-901, 2016-003881-14
First Posted : January 30, 2017
Last Update Posted : June 16, 2022
Last Verified : June 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No