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A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

NCT03668119

Description:

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
  • Official Title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Clinical Trial IDs

  • ORG STUDY ID: CA209-848
  • SECONDARY ID: 2016-002898-35
  • NCT ID: NCT03668119

Conditions

  • Pan Tumor

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Nivolumab + Ipilimumab Combination
IpilimumabYervoy, BMS-734016Nivolumab + Ipilimumab Combination

Purpose

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)

Trial Arms

NameTypeDescriptionInterventions
Nivolumab + Ipilimumab CombinationExperimental
    Nivolumab MonotherapyExperimental

      Eligibility Criteria

              For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
              visit www.BMSStudyConnect.com
      
              Inclusion Criteria:
      
                -  Refractory, metastatic, or unresectable TMB-H solid tumors who must have received at
                   least one prior line of therapy including standard of care, if available
      
                -  Available tumor tissue and blood for TMB testing
      
                -  Participants must have measurable disease for response assessment
      
              Exclusion Criteria:
      
                -  Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma
                   (RCC) or hematological malignancy as primary site of disease
      
                -  Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2,
                   anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically
                   targeting T-cell co-stimulation or checkpoint pathways
      
                -  Treatment with any chemotherapy, radiation therapy, biologics for cancer, or
                   investigational therapy within 28 days of first administration of study treatment
      
              Other protocol defined inclusion/exclusion criteria could apply
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:12 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Objective Response Rate (ORR)
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:Assessed by blinded independent central review (BICR)

      Secondary Outcome Measures

      Measure:Duration of response (DOR)
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:Assessed by BICR and investigator
      Measure:ORR
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:Assessed by investigator
      Measure:TTR
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:Assessed by BICR and investigator
      Measure:Clinical benefit rate (CBR)
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:Assessed by BICR and investigator
      Measure:Overall survival (OS)
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:
      Measure:PFS
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:Assessed by BICR and investigator
      Measure:Incidence of Adverse Events (AEs)
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:
      Measure:Incidence of Serious Adverse Events (SAEs)
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:
      Measure:Incidence of laboratory abnormalities
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:
      Measure:Incidence of anti-drug antibody (ADA)
      Time Frame:Approximately 3 years
      Safety Issue:
      Description:Measured by immunoassay

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Bristol-Myers Squibb

      Trial Keywords

      • TMB-H

      Last Updated