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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03141177
Other study ID # CA209-9ER
Secondary ID 2017-000759-20
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 22, 2017
Est. completion date April 17, 2024

Study information

Verified date January 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 Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 701
Est. completion date April 17, 2024
Est. primary completion date February 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Nivolumab
Specified dose on specified day
Drug:
Cabozantinib
Specified dose on specified days
Sunitinib
Specified dose on specified days.
Biological:
Ipilimumab
Specified dose on specified days

Locations

Country Name City State
Argentina Local Institution - 0046 Caba Buenos Aires
Argentina Local Institution - 0138 Caba
Argentina Local Institution - 0048 Ciudad Autonoma De Buenos Aire Buenos Aires
Argentina Local Institution - 0049 Cordoba
Argentina Local Institution - 0050 Cordoba
Argentina Local Institution - 0047 Tucuman
Argentina Local Institution - 0114 Viedma RIO Negro
Australia Local Institution - 0007 Doubleview Western Australia
Australia Local Institution - 0004 Elizabeth Vale South Australia
Australia Local Institution - 0006 Herston Queensland
Australia Local Institution - 0005 Malvern Victoria
Australia Local Institution - 0002 North Ryde New South Wales
Australia Local Institution - 0129 South Brisbane
Australia Local Institution - 0001 Southport Queensland
Australia Local Institution - 0008 Sydney New South Wales
Australia Local Institution - 0009 Sydney New South Wales
Australia Local Institution - 0073 Westmead New South Wales
Brazil Local Institution - 0058 Barretos Sao Paulo
Brazil 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 - 0066 Rio De Janeiro
Brazil Local Institution - 0061 Sao Paulo
Brazil Local Institution - 0074 Sao Paulo
Chile Local Institution - 0045 Santiago Metropolitana
Czechia Local Institution - 0034 Hradec Kralove
Czechia Local Institution - 0033 Olomouc
Germany 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 - 0014 Nuernberg
Germany Local Institution - 0011 Tuebingen
Greece Local Institution - 0082 Athens
Greece Local Institution - 0083 Thessaloniki
Israel Local Institution - 0072 Haifa
Israel Local Institution - 0070 Kfar Saba
Israel Local Institution - 0071 Petah Tikva
Israel Local Institution - 0069 Ramat Gan
Italy Local Institution - 0054 Arezzo
Italy Local Institution - 0052 Milano
Italy Local Institution - 0055 Napoli
Italy Local Institution - 0053 Padova
Italy Local Institution - 0051 Pavia
Italy Local Institution - 0147 Pavia
Italy Local Institution - 0172 Terni
Japan Local Institution - 0152 Adachi-ku Tokyo
Japan Local Institution - 0148 Akita-shi Akita
Japan Local Institution - 0156 Aomori
Japan Local Institution - 0151 Bunkyo-ku Tokyo
Japan Local Institution - 0158 Bunkyo-ku Tokyo
Japan Local Institution - 0167 Chiba
Japan Local Institution - 0161 Fukuoka
Japan Local Institution - 0155 Hidaka-shi Saitama
Japan Local Institution - 0168 Kobe Hyogo
Japan Local Institution - 0173 Minato-ku Tokyo
Japan Local Institution - 0159 Morioka Iwate
Japan Local Institution - 0162 Nagasaki
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 - 0164 Sapporo Hokkaido
Japan Local Institution - 0157 Sapporo-shi Hokkaido
Japan Local Institution - 0163 Suita-shi Osaka
Japan Local Institution - 0153 Tokushima-shi Tokushima
Japan Local Institution - 0149 Tokyo
Japan Local Institution - 0165 Yamagata
Japan Local Institution - 0166 Yokohama Kanagawa
Japan Local Institution - 0171 Yokohama Kanagawa
Mexico Local Institution - 0062 Ciudad de Mexico Distrito Federal
Mexico Local Institution - 0136 Merida Yucatan
Mexico Local Institution - 0116 Mexico Distrito Federal
Mexico Local Institution - 0064 Monterrey Nuevo Leon
Mexico Local Institution - 0065 Monterrey Nuevo Leon
Mexico Local Institution - 0143 Monterrey Nuevo LEON
Mexico Local Institution - 0063 Queretaro
Mexico Local Institution - 0115 Tlalpan Distrito Federal
Mexico Local Institution - 0108 Zapopan Jalisco
Poland Local Institution - 0084 Biala Podlaska
Poland Local Institution - 0130 Bydgoszcz
Poland Local Institution - 0085 Gdansk
Romania Local Institution - 0021 Cluj-Napoca
Romania Local Institution - 0022 Craiova
Russian Federation Local Institution - 0020 Moscow
Russian Federation Local Institution - 0099 Saint-Petersburg
Spain Local Institution - 0125 Barcelona
Spain Local Institution - 0120 Madrid
Spain Local Institution - 0121 Madrid
Spain Local Institution - 0144 Santander
Spain Local Institution - 0124 Sevilla
Spain Local Institution - 0123 Valencia
Turkey Local Institution - 0094 Ankara
Turkey Local Institution - 0107 Ankara
Turkey Local Institution - 0139 Ankara
Turkey Local Institution - 0096 Antalya
Turkey Local Institution - 0097 Denizli
Turkey Local Institution - 0095 Edirne
Turkey Local Institution - 0146 Istanbul
United Kingdom Local Institution - 0111 London
United Kingdom Local Institution - 0109 Manchester
United Kingdom Local Institution - 0140 Truro
United States Local Institution - 0135 Allentown Pennsylvania
United States Local Institution - 0127 Athens Georgia
United States Local Institution - 0103 Aurora Colorado
United States Local Institution - 0133 Bakersfield California
United States Local Institution - 0037 Boston Massachusetts
United States Local Institution - 0113 Boston Massachusetts
United States Local Institution - 0040 Buffalo New York
United States Local Institution - 0036 Chicago Illinois
United States Local Institution - 0075 Dallas Texas
United States Local Institution - 0077 Daphne Alabama
United States Local Institution - 0091 Fort Wayne Indiana
United States Local Institution - 0044 Goodyear Arizona
United States Local Institution - 0068 Houston Texas
United States Local Institution - 0106 Kansas City Missouri
United States Local Institution - 0102 Las Vegas Nevada
United States Local Institution - 0093 Los Angeles California
United States Local Institution - 0105 Nashville Tennessee
United States Local Institution - 0017 New York New York
United States Local Institution - 0086 Newnan Georgia
United States Local Institution - 0131 Norfolk Virginia
United States Local Institution - 0067 Portland Oregon
United States Local Institution - 0090 Redondo Beach California
United States Local Institution - 0035 Saint Louis Missouri
United States Local Institution - 0080 San Antonio Texas
United States Local Institution - 0088 San Luis Obispo California
United States Central Coast Medical Oncology Corporation Santa Maria California
United States Local Institution - 0078 Sherman Texas
United States Local Institution - 0132 Tucson Arizona
United States Local Institution - 0087 Wichita Kansas
United States Local Institution - 0042 Zion Illinois

Sponsors (3)

Lead Sponsor Collaborator
Bristol-Myers Squibb Exelixis, Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Chile,  Czechia,  Germany,  Greece,  Israel,  Italy,  Japan,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) 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 From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
Secondary Overall Survival (OS) 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"). From randomization date to death date (Up to 31 months)
Secondary Objective Response Rate (ORR) 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.
Up to 31 Months
Secondary Number of Participants Experiencing Adverse Events (AEs) Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame. From first dose to 100 days following last dose (Up to 32 Months)
Secondary Number of Participants Experiencing Serious Adverse Events (SAEs) Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame. From first to dose to 100 days following last dose (Up to 32 months)
Secondary Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame. From first dose to 30 days following last dose (Up to 30 months)
Secondary Number of Deaths Number of deaths due to any cause during the specified time frame. From first dose to (up to 31 months) following first dose
Secondary Number of Participants With Laboratory Abnormalities Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame. From first dose to 30 days following last dose (Up to 30 Months)
Secondary Number of Participants With Laboratory Values Grade Shifting From Baseline Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame. From first dose to 30 days following last dose (Up to 30 Months)
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