A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
About the study
Who can take part
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
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
- Participants who have received a live/attenuated vaccine within 30 days of first treatment
Other protocol defined inclusion/exclusion criteria could apply
Study Locations
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How to Apply
Study’s details
Contition
Renal Cell Carcinoma
Age (in years)
18+
Phase
Phase 3
Participants needed
701
Est. Completion Date
Apr 17, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT03141177
Study number
CA2099ER
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