Advanced or Metastatic Renal Cell Carcinoma MedDRA version: 21.1 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 510 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in the treatment of Kidney cancer in patients with previously untreated, advanced, or cancer that has spread;Secondary Objective: To compare overall survival (OS) of Arm A with Arm C in all randomized participants. To evaluate the objective response rate (ORR) per BICR in all randomized participants. To assess overall safety and tolerability in all treated participants.;Primary end point(s): 1. Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants;Timepoint(s) of evaluation of this end point: 1. Time Frame: Up to 22 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Overall Survival (OS) of Arm A versus Arm C 2. Objective Response Rate (ORR) 3. Incidence of adverse events (AEs) 4. Incidence of Serious Adverse Events (SAEs);Timepoint(s) of evaluation of this end point: 1. Time Frame: Up to 34 months 2. Time Frame: Approximately 16 months 3. Time Frame: Up to 34 months 4. Time Frame: Up to 34 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Chile, Czechia, Czech Republic, France, Germany, Greece, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Turkey, United Kingdom
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed