Print

Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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 - Participants who have received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria could apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Doublet 		Nivolumab and Cabozantinib
  • Biological: Nivolumab
    Specified dose on specified day
    Other names:
    • Opdivo
    • BMS-936558
  • Drug: Cabozantinib
    Specified dose on specified days
    Other names:
    • Cabometyx
Active Comparator
Monotherapy 		Sunitinib
  • Drug: Sunitinib
    Specified dose on specified days.
    Other names:
    • Sutent
Experimental
Triplet 		Nivolumab, Ipilimumab, Cabozantinib *Enrollment to the triplet arm was discontinued by protocol amendment
  • Biological: Ipilimumab
    Specified dose on specified days
    Other names:
    • Yervoy
    • BMS-734016

More Details

Status
Active, not recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.