Kidney Cancer Clinical Trial

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Summary

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

View Eligibility Criteria

Eligibility Criteria

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

Inclusion Criteria:

Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC

No prior systemic therapy for RCC with the following exception:

i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Exclusion Criteria:

Any active CNS metastases
Any active, known or suspected autoimmune disease
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Participants who have received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria could apply

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

701

Study ID:

NCT03141177

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 133 Locations for this study

See Locations Near You

Local Institution - 0077
Daphne Alabama, 36526, United States
Local Institution - 0044
Goodyear Arizona, 85338, United States
Local Institution - 0132
Tucson Arizona, 85724, United States
Local Institution - 0133
Bakersfield California, 93309, United States
Local Institution - 0093
Los Angeles California, 90404, United States
Local Institution - 0090
Redondo Beach California, 90277, United States
Local Institution - 0088
San Luis Obispo California, 93401, United States
Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
Local Institution - 0103
Aurora Colorado, 80045, United States
Local Institution - 0127
Athens Georgia, 30607, United States
Local Institution - 0086
Newnan Georgia, 30265, United States
Local Institution - 0036
Chicago Illinois, 60612, United States
Local Institution - 0042
Zion Illinois, 60099, United States
Local Institution - 0091
Fort Wayne Indiana, 46804, United States
Local Institution - 0087
Wichita Kansas, 67214, United States
Local Institution - 0113
Boston Massachusetts, 02114, United States
Local Institution - 0037
Boston Massachusetts, 02215, United States
Local Institution - 0106
Kansas City Missouri, 64132, United States
Local Institution - 0035
Saint Louis Missouri, 63110, United States
Local Institution - 0102
Las Vegas Nevada, 89169, United States
Local Institution - 0040
Buffalo New York, 14263, United States
Local Institution - 0017
New York New York, 10065, United States
Local Institution - 0067
Portland Oregon, 97239, United States
Local Institution - 0135
Allentown Pennsylvania, 18105, United States
Local Institution - 0105
Nashville Tennessee, 37203, United States
Local Institution - 0075
Dallas Texas, 75246, United States
Local Institution - 0068
Houston Texas, 77030, United States
Local Institution - 0080
San Antonio Texas, 78240, United States
Local Institution - 0078
Sherman Texas, 75090, United States
Local Institution - 0131
Norfolk Virginia, 23502, United States
Local Institution - 0046
Caba Buenos Aires, C1120, Argentina
Local Institution - 0048
Ciudad Autonoma De Buenos Aire Buenos Aires, 1181, Argentina
Local Institution - 0114
Viedma RIO Negro, 8500, Argentina
Local Institution - 0138
Caba , 1426, Argentina
Local Institution - 0050
Cordoba , 5000, Argentina
Local Institution - 0049
Cordoba , X5004, Argentina
Local Institution - 0047
Tucuman , 4000, Argentina
Local Institution - 0002
North Ryde New South Wales, 0, Australia
Local Institution - 0008
Sydney New South Wales, 2010, Australia
Local Institution - 0009
Sydney New South Wales, 2139, Australia
Local Institution - 0073
Westmead New South Wales, 2145, Australia
Local Institution - 0006
Herston Queensland, 4006, Australia
Local Institution - 0001
Southport Queensland, 4215, Australia
Local Institution - 0004
Elizabeth Vale South Australia, 5112, Australia
Local Institution - 0005
Malvern Victoria, 3144, Australia
Local Institution - 0007
Doubleview Western Australia, 6018, Australia
Local Institution - 0129
South Brisbane , 4101, Australia
Local Institution - 0057
Belo Horizonte Minas Gerais, 30130, Brazil
Local Institution - 0119
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0056
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0060
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Local Institution - 0058
Barretos Sao Paulo, 14784, Brazil
Local Institution - 0066
Rio De Janeiro , 20231, Brazil
Local Institution - 0074
Sao Paulo , 01323, Brazil
Local Institution - 0061
Sao Paulo , 05651, Brazil
Local Institution - 0045
Santiago Metropolitana, 84203, Chile
Local Institution - 0034
Hradec Kralove , 500 0, Czechia
Local Institution - 0033
Olomouc , 779 0, Czechia
Local Institution - 0013
Aachen , 52074, Germany
Local Institution - 0016
Bonn , 53127, Germany
Local Institution - 0117
Essen , 45136, Germany
Local Institution - 0023
Jena , 07747, Germany
Local Institution - 0010
Muenchen , 81675, Germany
Local Institution - 0014
Nuernberg , 90419, Germany
Local Institution - 0011
Tuebingen , 72076, Germany
Local Institution - 0082
Athens , 11528, Greece
Local Institution - 0083
Thessaloniki , 546 4, Greece
Local Institution - 0072
Haifa , 31096, Israel
Local Institution - 0070
Kfar Saba , 44281, Israel
Local Institution - 0071
Petah Tikva , 49414, Israel
Local Institution - 0069
Ramat Gan , 52621, Israel
Local Institution - 0054
Arezzo , 52100, Italy
Local Institution - 0052
Milano , 20132, Italy
Local Institution - 0055
Napoli , 80131, Italy
Local Institution - 0053
Padova , Padov, Italy
Local Institution - 0051
Pavia , 27100, Italy
Local Institution - 0147
Pavia , 27100, Italy
Local Institution - 0172
Terni , 05100, Italy
Local Institution - 0148
Akita-shi Akita, 010-8, Japan
Local Institution - 0157
Sapporo-shi Hokkaido, 06086, Japan
Local Institution - 0164
Sapporo Hokkaido, 06085, Japan
Local Institution - 0168
Kobe Hyogo, 65000, Japan
Local Institution - 0159
Morioka Iwate, 02085, Japan
Local Institution - 0171
Yokohama Kanagawa, 236-0, Japan
Local Institution - 0166
Yokohama Kanagawa, 241-8, Japan
Local Institution - 0150
Niigata-shi Niigata, 95185, Japan
Local Institution - 0169
Okayama-shi Okayama, 70085, Japan
Local Institution - 0154
Osaka Osaka-shi, 545-8, Japan
Local Institution - 0170
Osaka-shi Osaka, 54185, Japan
Local Institution - 0160
Osakasayamashi Osaka, 58985, Japan
Local Institution - 0163
Suita-shi Osaka, 565-0, Japan
Local Institution - 0155
Hidaka-shi Saitama, 35012, Japan
Local Institution - 0153
Tokushima-shi Tokushima, 77085, Japan
Local Institution - 0152
Adachi-ku Tokyo, 123-8, Japan
Local Institution - 0158
Bunkyo-ku Tokyo, 11385, Japan
Local Institution - 0151
Bunkyo-ku Tokyo, 11386, Japan
Local Institution - 0173
Minato-ku Tokyo, 10584, Japan
Local Institution - 0156
Aomori , 03685, Japan
Local Institution - 0167
Chiba , 260-8, Japan
Local Institution - 0161
Fukuoka , 812-8, Japan
Local Institution - 0162
Nagasaki , 85285, Japan
Local Institution - 0149
Tokyo , 160-8, Japan
Local Institution - 0165
Yamagata , 99095, Japan
Local Institution - 0062
Ciudad de Mexico Distrito Federal, 06100, Mexico
Local Institution - 0116
Mexico Distrito Federal, 14080, Mexico
Local Institution - 0115
Tlalpan Distrito Federal, 14080, Mexico
Local Institution - 0108
Zapopan Jalisco, 45070, Mexico
Local Institution - 0065
Monterrey Nuevo Leon, 64000, Mexico
Local Institution - 0143
Monterrey Nuevo LEON, 64060, Mexico
Local Institution - 0064
Monterrey Nuevo Leon, 64460, Mexico
Local Institution - 0136
Merida Yucatan, 97125, Mexico
Local Institution - 0063
Queretaro , 76000, Mexico
Local Institution - 0084
Biala Podlaska , 21-50, Poland
Local Institution - 0130
Bydgoszcz , 85796, Poland
Local Institution - 0085
Gdansk , 80-21, Poland
Local Institution - 0021
Cluj-Napoca , 40001, Romania
Local Institution - 0022
Craiova , 20054, Romania
Local Institution - 0020
Moscow , 12528, Russian Federation
Local Institution - 0099
Saint-Petersburg , 19775, Russian Federation
Local Institution - 0125
Barcelona , 08035, Spain
Local Institution - 0121
Madrid , 28009, Spain
Local Institution - 0120
Madrid , 28041, Spain
Local Institution - 0144
Santander , 39008, Spain
Local Institution - 0124
Sevilla , 41013, Spain
Local Institution - 0123
Valencia , 46014, Spain
Local Institution - 0107
Ankara , 06018, Turkey
Local Institution - 0139
Ankara , 06590, Turkey
Local Institution - 0094
Ankara , 06800, Turkey
Local Institution - 0096
Antalya , 07070, Turkey
Local Institution - 0097
Denizli , 20070, Turkey
Local Institution - 0095
Edirne , 22030, Turkey
Local Institution - 0146
Istanbul , 34300, Turkey
Local Institution - 0111
London , EC1A , United Kingdom
Local Institution - 0109
Manchester , M20 4, United Kingdom
Local Institution - 0140
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

701

Study ID:

NCT03141177

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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