A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
- Conditions
- Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT03141177
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 701
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doublet Nivolumab Nivolumab and Cabozantinib Triplet Ipilimumab Nivolumab, Ipilimumab, Cabozantinib \*Enrollment to the triplet arm was discontinued by protocol amendment Doublet Cabozantinib Nivolumab and Cabozantinib Monotherapy Sunitinib Sunitinib
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months) PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study
- Secondary Outcome Measures
Name Time Method Number of Deaths From first dose to (up to 31 months) following first dose Number of deaths due to any cause during the specified time frame.
Number of Participants Experiencing Serious Adverse Events (SAEs) From first to dose to 100 days following last dose (Up to 32 months) Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation From first dose to 30 days following last dose (Up to 30 months) Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.
Objective Response Rate (ORR) Up to 31 Months Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants.
Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.Overall Survival (OS) From randomization date to death date (Up to 31 months) Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").
Number of Participants Experiencing Adverse Events (AEs) From first dose to 100 days following last dose (Up to 32 Months) Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.
Number of Participants With Laboratory Abnormalities From first dose to 30 days following last dose (Up to 30 Months) Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.
Number of Participants With Laboratory Values Grade Shifting From Baseline From first dose to 30 days following last dose (Up to 30 Months) Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.
Trial Locations
- Locations (135)
Local Institution - 0148
🇯🇵Akita-shi, Akita, Japan
Local Institution - 0156
🇯🇵Hirosaki, Aomori, Japan
Local Institution - 0157
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 0164
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0168
🇯🇵Kobe, Hyogo, Japan
Local Institution - 0159
🇯🇵Morioka, Iwate, Japan
Local Institution - 0171
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 0166
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 0150
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0169
🇯🇵Okayama-shi, Okayama, Japan
Local Institution - 0154
🇯🇵Osaka, Osaka-shi, Japan
Local Institution - 0170
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0160
🇯🇵Osakasayamashi, Osaka, Japan
Local Institution - 0163
🇯🇵Suita-shi, Osaka, Japan
Local Institution - 0130
🇵🇱Bydgoszcz, Poland
Local Institution - 0055
🇮🇹Napoli, Italy
Local Institution - 0053
🇮🇹Padova, Italy
Local Institution - 0051
🇮🇹Pavia, Italy
Local Institution - 0147
🇮🇹Pavia, Italy
Local Institution - 0172
🇮🇹Terni, Italy
Local Institution - 0011
🇩🇪Tuebingen, Germany
Local Institution - 0082
🇬🇷Athens, Greece
Local Institution - 0083
🇬🇷Thessaloniki, Greece
Local Institution - 0072
🇮🇱Haifa, Israel
Local Institution - 0070
🇮🇱Kfar Saba, Israel
Local Institution - 0071
🇮🇱Petah Tikva, Israel
Local Institution - 0069
🇮🇱Ramat Gan, Israel
Local Institution - 0054
🇮🇹Arezzo, Italy
Local Institution - 0077
🇺🇸Daphne, Alabama, United States
Local Institution - 0044
🇺🇸Goodyear, Arizona, United States
Local Institution - 0132
🇺🇸Tucson, Arizona, United States
Local Institution - 0133
🇺🇸Bakersfield, California, United States
Local Institution - 0093
🇺🇸Los Angeles, California, United States
Local Institution - 0090
🇺🇸Redondo Beach, California, United States
Local Institution - 0088
🇺🇸San Luis Obispo, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Local Institution - 0103
🇺🇸Aurora, Colorado, United States
Local Institution - 0127
🇺🇸Athens, Georgia, United States
Local Institution - 0006
🇦🇺Herston, Queensland, Australia
Local Institution - 0086
🇺🇸Newnan, Georgia, United States
Local Institution - 0036
🇺🇸Chicago, Illinois, United States
Local Institution - 0042
🇺🇸Zion, Illinois, United States
Local Institution - 0091
🇺🇸Fort Wayne, Indiana, United States
Local Institution - 0087
🇺🇸Wichita, Kansas, United States
Local Institution - 0113
🇺🇸Boston, Massachusetts, United States
Local Institution - 0037
🇺🇸Boston, Massachusetts, United States
Local Institution - 0106
🇺🇸Kansas City, Missouri, United States
Local Institution - 0035
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0102
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0040
🇺🇸Buffalo, New York, United States
Local Institution - 0017
🇺🇸New York, New York, United States
Local Institution - 0067
🇺🇸Portland, Oregon, United States
Local Institution - 0135
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0105
🇺🇸Nashville, Tennessee, United States
Local Institution - 0080
🇺🇸Austin, Texas, United States
Local Institution - 0075
🇺🇸Dallas, Texas, United States
Local Institution - 0068
🇺🇸Houston, Texas, United States
Local Institution - 0078
🇺🇸Sherman, Texas, United States
Local Institution - 0131
🇺🇸Norfolk, Virginia, United States
Local Institution - 0046
🇦🇷Caba, Buenos Aires, Argentina
Local Institution - 0048
🇦🇷Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Local Institution - 0114
🇦🇷Viedma, RIO Negro, Argentina
Local Institution - 0138
🇦🇷Caba, Argentina
Local Institution - 0050
🇦🇷Cordoba, Argentina
Local Institution - 0014
🇩🇪Nuernberg, Germany
Local Institution - 0049
🇦🇷Cordoba, Argentina
Local Institution - 0047
🇦🇷Tucuman, Argentina
Local Institution - 0002
🇦🇺North Ryde, New South Wales, Australia
Local Institution - 0008
🇦🇺Sydney, New South Wales, Australia
Local Institution - 0009
🇦🇺Sydney, New South Wales, Australia
Local Institution - 0073
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0001
🇦🇺Southport, Queensland, Australia
Local Institution - 0004
🇦🇺Elizabeth Vale, South Australia, Australia
Local Institution - 0005
🇦🇺Malvern, Victoria, Australia
Local Institution - 0007
🇦🇺Doubleview, Western Australia, Australia
Local Institution - 0129
🇦🇺South Brisbane, Australia
Local Institution - 0057
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0119
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0056
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0060
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0058
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0066
🇧🇷Rio De Janeiro, Brazil
Local Institution - 0074
🇧🇷Sao Paulo, Brazil
Local Institution - 0061
🇧🇷Sao Paulo, Brazil
Local Institution - 0045
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0034
🇨🇿Hradec Kralove, Czechia
Local Institution - 0033
🇨🇿Olomouc, Czechia
Local Institution - 0013
🇩🇪Aachen, Germany
Local Institution - 0016
🇩🇪Bonn, Germany
Local Institution - 0117
🇩🇪Essen, Germany
Local Institution - 0023
🇩🇪Jena, Germany
Local Institution - 0010
🇩🇪Muenchen, Germany
Local Institution - 0052
🇮🇹Milano, Italy
Local Institution - 0155
🇯🇵Hidaka-shi, Saitama, Japan
Local Institution - 0153
🇯🇵Tokushima-shi, Tokushima, Japan
Local Institution - 0152
🇯🇵Adachi-ku, Tokyo, Japan
Local Institution - 0158
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0151
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0173
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0167
🇯🇵Chiba, Japan
Local Institution - 0161
🇯🇵Fukuoka, Japan
Local Institution - 0162
🇯🇵Nagasaki, Japan
Local Institution - 0149
🇯🇵Tokyo, Japan
Local Institution - 0165
🇯🇵Yamagata, Japan
Local Institution - 0062
🇲🇽Ciudad de Mexico, Distrito Federal, Mexico
Local Institution - 0116
🇲🇽Mexico, Distrito Federal, Mexico
Local Institution - 0115
🇲🇽Tlalpan, Distrito Federal, Mexico
Local Institution - 0108
🇲🇽Zapopan, Jalisco, Mexico
Local Institution - 0065
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0143
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0064
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0063
🇲🇽Santiago de Queretaro, Querétaro, Mexico
Local Institution - 0136
🇲🇽Merida, Yucatan, Mexico
Local Institution - 0084
🇵🇱Biala Podlaska, Poland
Local Institution - 0085
🇵🇱Gdansk, Poland
Local Institution - 0021
🇷🇴Cluj-Napoca, Romania
Local Institution - 0022
🇷🇴Craiova, Romania
Local Institution - 0020
🇷🇺Moscow, Russian Federation
Local Institution - 0099
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0125
🇪🇸Barcelona, Spain
Local Institution - 0121
🇪🇸Madrid, Spain
Local Institution - 0120
🇪🇸Madrid, Spain
Local Institution - 0144
🇪🇸Santander, Spain
Local Institution - 0124
🇪🇸Sevilla, Spain
Local Institution - 0123
🇪🇸Valencia, Spain
Local Institution - 0107
🇹🇷Ankara, Turkey
Local Institution - 0139
🇹🇷Ankara, Turkey
Local Institution - 0094
🇹🇷Ankara, Turkey
Local Institution - 0096
🇹🇷Antalya, Turkey
Local Institution - 0097
🇹🇷Denizli, Turkey
Local Institution - 0095
🇹🇷Edirne, Turkey
Local Institution - 0146
🇹🇷Istanbul, Turkey
Local Institution - 0111
🇬🇧London, United Kingdom
Local Institution - 0109
🇬🇧Manchester, United Kingdom
Local Institution - 0140
🇬🇧Truro, United Kingdom