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An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread

NCT02832167

Description:

The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open Label Phase 2 Multicohort Trial of Nivolumab in Advanced or Metastatic Malignancies
  • Official Title: An Open Label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies

Clinical Trial IDs

  • ORG STUDY ID: CA209-627
  • SECONDARY ID: 2016-000461-23
  • NCT ID: NCT02832167

Conditions

  • Cancer

Interventions

DrugSynonymsArms
BMS936558Nivolumab

Purpose

The purpose of this study is to determine whether Nivolumab is an effective treatment for advanced or metastatic cancer. The study will evaluate the clinical benefit rate of Nivolumab in subjects at 16 weeks from enrollment. Various advanced or metastatic tumor types are eligible for enrollment. Subjects must have received prior standard of care treatment for their cancer before enrollment.

Trial Arms

NameTypeDescriptionInterventions
NivolumabExperimental

    Eligibility Criteria

            For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
            visit www.BMSStudyConnect.com
    
            Inclusion Criteria:
    
              -  Diagnosed with advanced or metastatic malignancy
    
              -  Received standard of care treatment for primary malignancy and standard of care
                 treatment for relapsed cancer
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    
            Exclusion Criteria:
    
              -  Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4
                 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation
                 or checkpoint pathways.
    
              -  Subjects previously treated with investigational anticancer therapies less than 6
                 weeks prior to the first dose of Nivolumab
    
              -  Subjects with an active, known, or suspected autoimmune disease
    
            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:Clinical Benefit Rate measured by radiologic tumor assessments
    Time Frame:Change from baseline to week 16
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall Survival rate (OS)
    Time Frame:1 Year
    Safety Issue:
    Description:
    Measure:Duration of clinical response
    Time Frame:Up to one year
    Safety Issue:
    Description:
    Measure:Incidence of adverse events (AEs)
    Time Frame:Up to one year
    Safety Issue:
    Description:Safety and Tolerability
    Measure:Grade of AEs
    Time Frame:Up to one year
    Safety Issue:
    Description:Safety and Tolerability
    Measure:Radiologic Tumor Assessments to characterize Pseudoprogression
    Time Frame:Up to one year
    Safety Issue:
    Description:

    Details

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

    Last Updated

    April 17, 2017