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NCT03036098 Clinical Trial

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

Urothelial Cancer Clinical Trial

— CheckMate901  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03036098
Other study ID # CA209-901
Secondary ID 2016-003881-14
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 24, 2017
Est. completion date June 1, 2028

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1290
Est. completion date June 1, 2028
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Nivolumab
Specified Dose on Specified Days
• Ipilimumab
Specified Dose on Specified Days
Drug:
• Gemcitabine
Specified Dose on Specified Days
• Cisplatin
Specified Dose on Specified Days
• Carboplatin
Specified Dose on Specified Days

Locations
Country Name City State
Argentina Local Institution - 0009 Buenos Aires
Argentina Local Institution - 0005 Capital Federal Buenos Aires
Argentina Local Institution - 0006 Cordoba
Argentina Local Institution - 0134 Cordoba
Argentina Local Institution - 0007 Mar Del Plata Buenos Aires
Argentina Local Institution - 0008 Viedma RIO Negro
Australia Local Institution - 0100 Doubleview Western Australia
Australia Local Institution - 0101 Heidelberg Victoria
Australia Local Institution - 0188 South Brisbane Queensland
Australia Local Institution - 0120 Tugun Queensland
Australia Local Institution - 0096 Waratah New South Wales
Australia Local Institution - 0099 Westmead New South Wales
Brazil Local Institution - 0018 Barretos Sao Paulo
Brazil Local Institution - 0017 Brasilia Distrito Federal
Brazil Local Institution - 0016 Florianopolis Santa Catarina
Brazil Local Institution - 0021 Ijui RIO Grande DO SUL
Brazil Local Institution - 0119 Passo Fundo RIO Grande DO SUL
Brazil Local Institution - 0020 Porto Alegre RIO Grande DO SUL
Brazil Local Institution - 0019 Sao Jose Do Rio Preto Sao Paulo
Canada Local Institution - 0053 Halifax Nova Scotia
Canada Local Institution - 0064 London Ontario
Canada Local Institution - 0054 Quebec City Quebec
Canada Local Institution - 0052 Sherbrooke Quebec
Chile Local Institution - 0010 Santiago Metropolitana
Chile Local Institution - 0012 Vina del Mar Valparaiso
Chile Local Institution - 0106 Vitacura
China Local Institution - 0169 Beijing Beijing
China Local Institution - 0170 Beijing
China Local Institution - 0171 Beijing Beijing
China Local Institution - 0186 Changchun Jilin
China Local Institution - 0184 Chengdu Sichuan
China Local Institution - 0182 Chongqing Chongqing
China Local Institution - 0217 Guiyang Guizhou
China Local Institution - 0172 Hangzhou Zhejiang
China Local Institution - 0173 Hangzhou Zhejiang
China Local Institution - 0174 Hangzhou Zhejiang
China Local Institution - 0219 Harbin Heilongjiang
China Local Institution - 0176 Nanjing Jiangsu
China Local Institution - 0177 Nanjing Jiangsu
China Local Institution - 0175 Nanjng Jiangsu
China Local Institution - 0162 Shanghai Shanghai
China Local Institution - 0163 Shanghai Shanghai
China Local Institution - 0164 Shanghai
China Local Institution - 0167 Shanghai Shanghai
China Local Institution - 0220 Taiyuan Shan1xi
China Local Institution - 0180 Wuhan Hubei
China Local Institution - 0216 Yantai Shandong
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 Nîmes Gard
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 - 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 Ípeiros
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 Local Institution - 0149 Adachi-ku Tokyo
Japan Local Institution - 0142 Bunkyo-ku Tokyo
Japan Local Institution - 0148 Bunkyo-ku Tokyo
Japan Local Institution - 0135 Chiba-shi Chiba
Japan Local Institution - 0140 Fukuoka-shi Fukuoka
Japan Local Institution - 0201 Hamamatasu Shizuoka
Japan Local Institution - 0136 Hirosaki Aomori
Japan Local Institution - 0137 Kita-Gun Kagawa
Japan Local Institution - 0147 Matsuyama-shi Ehime
Japan Local Institution - 0214 Morioka-shi Iwate
Japan Local Institution - 0141 Niigata-shi Niigata
Japan Local Institution - 0143 Okayama-shi Okayama
Japan Local Institution - 0144 Osaka-shi Osaka
Japan Local Institution - 0139 Osakasayama Osaka
Japan Local Institution - 0146 Sapporo-city Hokkaido
Japan Local Institution - 0138 Shinjuku-Ku Tokyo
Japan Local Institution - 0145 Takatsuki-shi Osaka
Japan Local Institution - 0150 Tsukuba-shi Ibaraki
Japan Local Institution - 0200 Ube City Yamaguchi
Japan Local Institution - 0215 Wakayama-shi Wakayama
Korea, Republic of Local Institution - 0125 Goyang-si Gyeonggido
Korea, Republic of Local Institution - 0126 Seongnam-si
Korea, Republic of Local Institution - 0124 Seoul
Korea, Republic of Local Institution - 0127 Seoul
Korea, Republic of Local Institution - 0128 Seoul
Korea, Republic of Local Institution - 0151 Seoul
Mexico Local Institution - 0129 Ciudad de Mexico Distrito Federal
Mexico Local Institution - 0154 Mexico City Distrito Federal
Mexico Local Institution - 0131 Monterrey Nuevo Leon
Mexico Local Institution - 0130 Tlalpan Distrito Federal
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 Local Institution - 0191 Cluj-Napoca Cluj
Romania Local Institution - 0187 Craiova
Russian Federation Local Institution Moscow
Singapore Local Institution - 0192 Singapore Central 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 - 0155 Taipei
Taiwan Local Institution - 0158 Taipei
Taiwan Local Institution - 0157 Taoyuan
Turkey Local Institution - 0194 Ankara
Turkey Local Institution - 0204 Istanbul
Turkey Local Institution - 0193 Izmir
United States University Of New Mexico Albuquerque New Mexico
United States Alaska Urological Institute dba Alaska Clinical Research Center Anchorage Alaska
United States Local Institution - 0004 Athens Georgia
United States Local Institution - 0051 Boca Raton Florida
United States Local Institution - 0056 Boston Massachusetts
United States Local Institution - 0073 Boston Massachusetts
United States Local Institution - 0208 Boston Massachusetts
United States Local Institution - 0083 Buffalo New York
United States Local Institution - 0002 Burnsville Minnesota
United States Local Institution - 0046 Chicago Illinois
United States Local Institution - 0082 Columbus Ohio
United States Local Institution - 0116 Durham North Carolina
United States Local Institution - 0087 Fort Lauderdale Florida
United States Local Institution - 0115 Fresno California
United States Hattiesburg Clinic Hattiesburg Mississippi
United States Local Institution - 0062 Jacksonville Florida
United States Local Institution - 0032 Kansas City Missouri
United States Local Institution - 0086 Kirkland Washington
United States Local Institution - 0057 Manchester New Hampshire
United States Local Institution - 0207 Milford Massachusetts
United States Local Institution - 0014 Mineola New York
United States Local Institution - 0117 New Orleans Louisiana
United States Local Institution - 0072 New York New York
United States Local Institution - 0013 Pittsburgh Pennsylvania
United States Local Institution - 0104 Portland Oregon
United States Local Institution - 0095 Saint Louis Missouri
United States St Joseph Heritage Healthcare Santa Rosa California
United States Local Institution - 0033 Thomasville Georgia
United States Local Institution - 0063 Ypsilanti Michigan

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  Romania,  Russian Federation,  Singapore,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival (OS) in cisplatin-ineligible randomized participants Up to 55 months
Primary Overall survival (OS) in PD-L1 positive (>=1%) randomized participants by immunohistochemistry (IHC) Up to 52 months
Primary 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 Up to 64 months
Primary Overall survival (OS) in cisplatin-eligible participants with previously untreated, unresectable or metastatic UC Up to 64 months
Secondary Overall survival (OS) in all randomized participants Up to 55 months
Secondary 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 Up to 55 months
Secondary 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 Up to 55 months
Secondary Progression-free survival (PFS) by blinded independent central review (BICR) (using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1) in all randomized participants Up to 55 months
Secondary European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants Up to 55 months
Secondary 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 Up to 64 months
Secondary Progression-free survival (PFS) by BICR by PD-L1 expression at >=1% by immunohistochemistry (IHC) Up to 64 months
Secondary Overall survival (OS) by PD-L1 expression at = 1% expression by immunohistochemistry (IHC) Up to 64 months
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Active, not recruiting NCT02891161 - Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder Phase 1/Phase 2
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Active, not recruiting NCT02516241 - Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Phase 3
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