Clinical Trials /

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

NCT03141177

Description:

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

Related Conditions:
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-9ER
  • SECONDARY ID: 2017-000759-20
  • NCT ID: NCT03141177

Conditions

  • Renal Cell Carcinoma

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Doublet
CabozantinibCabometyxDoublet
SunitinibSutentMonotherapy
IpilimumabYervoy, BMS-734016Triplet

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

Trial Arms

NameTypeDescriptionInterventions
DoubletExperimentalNivolumab and Cabozantinib
  • Nivolumab
  • Cabozantinib
MonotherapyActive ComparatorSunitinib
  • Sunitinib
TripletExperimentalNivolumab, Ipilimumab, Cabozantinib *Enrollment to the triplet arm was discontinued by protocol amendment
  • Ipilimumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS) per blinded independent central review (BICR)
Time Frame:Up to 21 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Up to 64 months
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:Approximately 16 months
Safety Issue:
Description:
Measure:Incidence of adverse events (AEs)
Time Frame:Up to 64 months
Safety Issue:
Description:Safety and Tolerability
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Up to 64 months
Safety Issue:
Description:Safety and Tolerability

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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