A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
- Conditions
- MedDRA version: 21.1Level: PTClassification code: 10050513Term: Metastatic renal cell carcinoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]Advanced or Metastatic Renal Cell Carcinoma
- Registration Number
- CTIS2023-509711-83-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 755
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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): Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall Survival (OS) of Arm A versus Arm C;Secondary end point(s):Objective Response Rate (ORR);Secondary end point(s):Incidence of adverse events (AEs);Secondary end point(s):Incidence of Serious Adverse Events (SAEs)