Various Advanced Cancer Clinical Trial
— CheckMate 274Official title:
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
| Verified date | January 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
| Status | Active, not recruiting |
| Enrollment | 709 |
| Est. completion date | May 27, 2027 |
| Est. primary completion date | July 17, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis - Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days - Must have disease free status as determined by imaging within 4 weeks of dosing - Tumor tissue must be provided for biomarker analysis - Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy Exclusion Criteria: - Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy) - Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer - Subjects with active, known or suspected autoimmune disease - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured - Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration - Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0021 | Berazategui | Buenos Aires |
| Argentina | Local Institution - 0090 | Capital Federal | Buenos Aires |
| Argentina | Local Institution - 0089 | Ciudad Autonoma De Buenos Aire | Buenos Aires |
| Argentina | Local Institution - 0022 | Ciudad Autónoma de BuenosAires | Buenos Aires |
| Argentina | Local Institution - 0020 | San Miguel De Tucuman | Tucuman |
| Argentina | Local Institution - 0102 | Viedma | RIO Negro |
| Australia | Local Institution - 0050 | Elizabeth Vale | South Australia |
| Australia | Local Institution - 0184 | Frankston | Victoria |
| Australia | Local Institution - 0048 | Liverpool | New South Wales |
| Australia | Local Institution - 0175 | Perth | Western Australia |
| Australia | Local Institution - 0047 | St. Leonards | New South Wales |
| Australia | Local Institution - 0046 | Waratah | New South Wales |
| Austria | Local Institution - 0133 | Linz | |
| Austria | Local Institution - 0136 | Salzburg | |
| Austria | Local Institution - 0132 | Vienna | |
| Austria | Local Institution - 0183 | Wien | |
| Belgium | Local Institution - 0029 | Hasselt | |
| Belgium | Local Institution - 0027 | Liege | |
| Brazil | Local Institution - 0070 | Barretos | Sao Paulo |
| Brazil | Local Institution - 0073 | Cerqueira Cesar | SAO Paulo |
| Brazil | Local Institution - 0071 | Ijui | RIO Grande DO SUL |
| Brazil | Local Institution - 0072 | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution - 0231 | Rio De Janeiro | |
| Brazil | Local Institution - 0100 | São Paulo | |
| Canada | Local Institution - 0139 | Edmonton | Alberta |
| Canada | Local Institution - 0101 | Montreal | |
| Canada | Local Institution - 0109 | Montreal | Quebec |
| Canada | Local Institution - 0112 | Sherbrooke | Quebec |
| Chile | Local Institution - 0099 | Santiago | Metropolitana |
| Chile | Local Institution - 0137 | Temuco | |
| Chile | Local Institution - 0038 | Vina Del Mar | Valparaiso |
| China | Local Institution - 0191 | Beijing | Beijing |
| China | Local Institution - 0192 | Beijing | Beijing |
| China | Local Institution - 0206 | Beijing | Beijing |
| China | Local Institution - 0219 | Chengdu | Sichuan |
| China | Local Institution - 0229 | Chengdu | Sichuan |
| China | Local Institution - 0210 | Chongqing | Chongqing |
| China | Local Institution - 0198 | Fuzhou | Fujian |
| China | Local Institution - 0203 | Guangzhou | Guangdong |
| China | Local Institution - 0222 | Guangzhou | Guangdong |
| China | Local Institution - 0195 | Hangzhou | Zhejiang |
| China | Local Institution - 0221 | Hangzhou | Zhejiang |
| China | Local Institution - 0223 | Nanchang | Jiangxi |
| China | Local Institution - 0204 | Nanjing | Jiangsu |
| China | Local Institution - 0220 | Nanjing | Jiangsu |
| China | Local Institution - 0227 | Nanning | Guangxi |
| China | Local Institution - 0193 | Shanghai | Shanghai |
| China | Local Institution - 0199 | Shanghai | Shanghai |
| China | Local Institution - 0202 | Shanghai | Shanghai |
| China | Local Institution - 0217 | Shanghai | Shanghai |
| China | Local Institution - 0230 | Wenzhou | Zhejiang |
| China | Local Institution - 0196 | Wuhan | Hubei |
| China | Local Institution | Xi'an | Shan3xi |
| China | Local Institution - 0212 | Yantai | Shandong |
| Colombia | Local Institution - 0092 | Bogota | |
| Colombia | Local Institution - 0093 | Floridablanca | |
| Colombia | Local Institution - 0091 | Medellin | |
| Denmark | Local Institution - 0108 | Aalborg | |
| Denmark | Local Institution - 0106 | Aarhus N | |
| Denmark | Local Institution - 0107 | Copenhagen | |
| France | Local Institution - 0233 | Clermont-ferrand | |
| France | Local Institution - 0115 | La Roche-sur-Yon | |
| France | Local Institution - 0080 | Marseille Cedex 9 | |
| France | Local Institution - 0081 | Paris | |
| France | Local Institution - 0113 | Strasbourg | |
| France | Local Institution - 0097 | Suresnes | |
| France | Local Institution - 0098 | Villejuif | |
| Germany | Local Institution - 0131 | Chemnitz | |
| Germany | Local Institution - 0125 | Essen | |
| Germany | Local Institution - 0127 | Greifswald | |
| Germany | Local Institution - 0126 | Hamburg | |
| Germany | Local Institution - 0124 | Heidelberg | |
| Germany | Local Institution - 0123 | Jena | |
| Germany | Local Institution - 0188 | Marburg | |
| Germany | Local Institution - 0128 | Muenster | |
| Germany | Local Institution - 0122 | Munich | |
| Germany | Local Institution - 0185 | Nuernberg | |
| Germany | Local Institution - 0130 | Regensburg | |
| Germany | Local Institution - 0129 | Stuttgart | |
| Greece | Local Institution - 0110 | Athens | |
| Greece | Local Institution - 0111 | Thessaloniki | |
| Ireland | Local Institution - 0052 | Dublin | |
| Ireland | Local Institution - 0054 | Wilton | Cork |
| Israel | Local Institution - 0118 | Haifa | |
| Israel | Local Institution - 0121 | Jerusalem | |
| Israel | Local Institution - 0120 | Ramat Gan | |
| Israel | Local Institution - 0119 | Zerifin | |
| Italy | Local Institution - 0088 | Arezzo | |
| Italy | Local Institution - 0197 | Bergamo | |
| Italy | Local Institution - 0082 | Milano | |
| Italy | Local Institution - 0084 | Pisa | |
| Italy | Local Institution - 0189 | Reggio Emilia | |
| Italy | Local Institution - 0085 | Roma | |
| Italy | Local Institution - 0086 | Roma | |
| Italy | Local Institution - 0083 | Siena | |
| Japan | Local Institution - 0142 | Akita-shi | Akita |
| Japan | Local Institution - 0146 | Bunkyo-ku | Tokyo |
| Japan | Local Institution - 0143 | Chiba | |
| Japan | Local Institution - 0162 | Fukuoka-shi | Fukuoka |
| Japan | Local Institution - 0151 | Hamamatasu | Shizuoka |
| Japan | Local Institution - 0144 | Hirosaki | Aomori |
| Japan | Local Institution - 0163 | Nagasaki-shi | Nagasaki |
| Japan | Local Institution - 0150 | Niigata-shi | Niigata |
| Japan | Local Institution - 0141 | Okayama-city | Okayama |
| Japan | Local Institution - 0164 | Osaka | |
| Japan | Local Institution - 0149 | Osakasayama | Osaka |
| Japan | Local Institution - 0160 | Sapporo | Hokkaido |
| Japan | Local Institution - 0161 | Sapporo-shi | Hokkaido |
| Japan | Local Institution - 0145 | Shinjuku-Ku | Tokyo |
| Japan | Local Institution - 0147 | Shinjuku-ku | Tokyo |
| Japan | Local Institution - 0148 | Tsukuba-shi | Ibaraki |
| Korea, Republic of | Local Institution - 0155 | Seongnam-si | |
| Korea, Republic of | Local Institution - 0152 | Seoul | |
| Korea, Republic of | Local Institution - 0154 | Seoul | |
| Korea, Republic of | Local Institution - 0156 | Seoul | |
| Mexico | Local Institution - 0138 | Df | Distrito Federal |
| Mexico | Local Institution - 0035 | Guadalajara | Jalisco |
| Mexico | Local Institution - 0039 | Mexico | Distrito Federal |
| Mexico | Local Institution - 0116 | Mexico | Distrito Federal |
| Mexico | Local Institution - 0034 | Mexico City | Distrito Federal |
| Mexico | Local Institution - 0032 | Monterrey | Nuevo Leon |
| Netherlands | Local Institution - 0069 | Amsterdam | |
| Netherlands | Local Institution - 0068 | Maastrict | |
| Netherlands | Local Institution - 0041 | Nijmegen | |
| Peru | Local Institution - 0043 | Lima | |
| Poland | Local Institution - 0055 | Gdansk | |
| Poland | Local Institution - 0057 | Lodz | |
| Poland | Local Institution - 0187 | Warsaw | |
| Poland | Local Institution - 0058 | Wroclaw | |
| Poland | Local Institution - 0186 | Wroclaw | |
| Romania | Local Institution - 0182 | Bucuresti | |
| Romania | Local Institution - 0096 | Craiova | |
| Romania | Local Institution - 0078 | Floresti | |
| Romania | Local Institution - 0181 | Timisoara, Timis | |
| Russian Federation | Local Institution - 0140 | Moscow | |
| Russian Federation | Local Institution - 0031 | Saint-Petersburg | |
| Spain | Local Institution - 0067 | Badalona-barcelona | |
| Spain | Local Institution - 0066 | Barcelona | |
| Spain | Local Institution - 0062 | Madrid | |
| Spain | Local Institution - 0063 | Madrid | |
| Spain | Local Institution - 0064 | Madrid | |
| Spain | Local Institution - 0232 | Santander | |
| Spain | Local Institution - 0065 | Sevilla | |
| Sweden | Local Institution - 0105 | Lund | |
| Switzerland | Local Institution - 0134 | Basel | |
| Switzerland | Local Institution - 0135 | Zuerich | |
| Taiwan | Local Institution - 0158 | Kaohsiung | |
| Taiwan | Local Institution - 0159 | Taichung | |
| Taiwan | Local Institution - 0153 | Taipei | |
| United Kingdom | Local Institution - 0076 | Edinburgh | Midlothian |
| United Kingdom | Local Institution - 0036 | London | |
| United Kingdom | Local Institution - 0114 | London | |
| United Kingdom | Local Institution - 0025 | Manchester | Greater Manchester |
| United Kingdom | Local Institution - 0059 | Sheffield | Yorkshire |
| United Kingdom | Local Institution - 0024 | Sutton | Surrey |
| United States | Local Institution - 0176 | Albany | New York |
| United States | Local Institution - 0074 | Allentown | Pennsylvania |
| United States | Alaska Urological Institute dba Alaska Clinical Research Center | Anchorage | Alaska |
| United States | Local Institution - 0157 | Buffalo | New York |
| United States | Local Institution - 0051 | Burnsville | Minnesota |
| United States | Local Institution - 0166 | Chapel Hill | North Carolina |
| United States | Local Institution - 0009 | Chattanooga | Tennessee |
| United States | Local Institution - 0061 | Clovis | California |
| United States | Local Institution | Durham | North Carolina |
| United States | Local Institution - 0094 | Fort Wayne | Indiana |
| United States | Local Institution - 0167 | Gainesville | Florida |
| United States | Local Institution - 0173 | Grand Rapids | Michigan |
| United States | Local Institution - 0178 | Lakewood | Colorado |
| United States | Local Institution - 0177 | Las Vegas | Nevada |
| United States | Local Institution - 0168 | Maywood | Illinois |
| United States | Local Institution - 0030 | Miami Beach | Florida |
| United States | Local Institution - 0007 | Mineola | New York |
| United States | Local Institution - 0169 | Myrtle Beach | South Carolina |
| United States | Local Institution - 0171 | New Orleans | Louisiana |
| United States | Local Institution - 0001 | New York | New York |
| United States | Local Institution - 0006 | New York | New York |
| United States | Local Institution - 0234 | Norfolk | Virginia |
| United States | Local Institution - 0003 | Omaha | Nebraska |
| United States | Local Institution - 0011 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0040 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0010 | Portland | Oregon |
| United States | Local Institution - 0044 | Portland | Oregon |
| United States | Local Institution - 0004 | Rochester | Minnesota |
| United States | Local Institution - 0172 | Sacramento | California |
| United States | Local Institution - 0005 | San Francisco | California |
| United States | Local Institution - 0008 | Tampa | Florida |
| United States | Local Institution - 0180 | Tigard | Oregon |
| United States | Local Institution - 0179 | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease Free Survival (DFS) | The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first. | approximately up to 48 months | |
| Primary | Disease Free Survival (DFS) in PD-L1 Expression = 1% Population | The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first. | approximately up to 48 months | |
| Secondary | Non-Urothelial Tract Recurrence Free Survival | The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first. | up to 53 months | |
| Secondary | Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression = 1% Population | The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first. | up to 53 months | |
| Secondary | Overall Survival | the time from randomization to the date of death from any cause. | on going | |
| Secondary | Overall Survival in Participants With PD-L1 Expression = 1% | the time from randomization to the date of death from any cause. | on going | |
| Secondary | Disease Specific Survival | the time from randomization to the date of death due to disease (urothelial cancer). | on going | |
| Secondary | Disease Specific Survival in Participants With PD-L1 Expression = 1% | the time from randomization to the date of death due to disease (urothelial cancer). | on going |
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|---|---|---|---|
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