Clinical Trials /

A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma

NCT02996110

Description:

The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer

Related Conditions:
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma
  • Official Title: A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)

Clinical Trial IDs

  • ORG STUDY ID: CA018-005
  • SECONDARY ID: 2016-003082-26
  • NCT ID: NCT02996110

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Nivolumab + Ipilimumab
IpilimumabBMS-734016, YervoyNivolumab + Ipilimumab
BMS-986016Nivolumab + BMS-986016

Purpose

The purpose of this study is to determine whether nivolumab in combination with other therapies is more effective than nivolumab in combination with ipilimumab in treating patients/subjects with advanced renal cell carcinoma.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + IpilimumabActive ComparatorNivolumab + Ipilimumab
    Nivolumab + BMS-986016ExperimentalNivolumab + BMS-986016

      Eligibility Criteria

              For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
              visit www.BMSStudyConnect.com
      
              Inclusion Criteria:
      
                -  Advanced Renal Cell Carcinoma
      
                -  Must have at least 1 lesion with measurable disease
      
                -  Life expectancy of at least 3 months
      
              Exclusion Criteria:
      
                -  Patients/subjects with suspected or known central nervous system metastases unless
                   adequately treated
      
                -  Patients/subjects with autoimmune disease
      
                -  Patients/subjects who need daily oxygen therapy
      
              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:Objective Response Rate (ORR)
      Time Frame:Up to 24 weeks
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Safety as measured by incidence of AEs (Adverse Events)
      Time Frame:Up to 268 days
      Safety Issue:
      Description:
      Measure:Safety as measured by incidence of SAEs (Serious Adverse Events)
      Time Frame:Up to 268 days
      Safety Issue:
      Description:
      Measure:Tolerability as measured by incidence of AEs
      Time Frame:Up to 268 days
      Safety Issue:
      Description:
      Measure:Tolerability as measured by SAEs
      Time Frame:Up to 268 days
      Safety Issue:
      Description:

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Bristol-Myers Squibb

      Last Updated

      April 17, 2017