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A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib or Nivolumab and Ipilimumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (NCT03141177)

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib or Nivolumab and Ipilimumab Combined with Cabozantinib, is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
  • Biological: Nivolumab
    Specified dose on specified day
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Specified dose on specified days
    • Yervoy
    • BMS-734016
  • Drug: Cabozantinib
    Specified dose on specified days
    • Carbometyx
  • Drug: Sunitinib
    Specified dose on specified days.
    • Sutent
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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 Other protocol defined inclusion/exclusion criteria could apply

83 locations

Status:
recruiting
Type:
Interventional
Phase:
Start:
10 July, 2017
Updated:
31 July, 2017
Participants:
1014
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