Clinical Trials /

First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors

NCT03110107

Description:

The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors
  • Official Title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA022-001
  • SECONDARY ID: 2017-000597-11
  • NCT ID: NCT03110107

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
IpilimumabYervoyMonotherapy
BMS-986218Monotherapy
NivolumabOpdivoCombination Therapy

Purpose

The purpose of this study is to determine whether a Monoclonal Antibody both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Trial Arms

NameTypeDescriptionInterventions
MonotherapyExperimentalIpilimumab Monotherapy and BMS-986218 Monotherapy
    Combination TherapyExperimentalBMS-986218 in combination with Nivolumab

      Eligibility Criteria

              Inclusion Criteria:
      
                -  For more information regarding Bristol-Myers Squibb Clinical Trial participation,
                   please visit www.BMSStudyConnect.com
      
                -  histologic or cytologic confirmation of a solid tumor that is advanced (metastatic,
                   recurrent and/or unresectable)
      
                -  Eastern Cooperative Oncology Group Performance Status of 0 or 1
      
                -  Participants must have received, and then progressed, relapsed, or been intolerant
                   to, all standard treatment regimens with proven survival benefit in the advanced or
                   metastatic setting according to tumor type, if such a therapy exists
      
              Exclusion Criteria:
      
                -  Participants with primary CNS malignancies, or tumors with CNS metastases as the only
                   site of disease, will be excluded
      
                -  Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior
                   anti-cancer therapy and initiation of study therapy
      
                -  Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or
                   immunotherapy (including anti-PD-1/PD-L1) are permitted
      
              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:Incidence of Adverse Events (AEs)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:ORR of BMS-986218 alone or in combination with Nivolumab
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:mDOR of BMS-986218 alone or in combination with Nivolumab
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:PFS of BMS-986218 alone or in combination with Nivolumab
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Incidence of anti-drug antibody to BMS-986218
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Percentage of change from baseline in T-regulatory cells (Tregs)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Maximum observed serum concentration (Cmax)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Time of maximum observed concentration (Tmax)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Area under the concentration-time curve
      Time Frame:Up to 3 years
      Safety Issue:
      Description:Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)]
      Measure:Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Trough observed serum concentration (Ctrough)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Total body clearance (CLT)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)]
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Terminal serum half-life if data permit (T-HALF)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:
      Measure:Observed concentration at the end of a dosing interval (Ctau)
      Time Frame:Up to 3 years
      Safety Issue:
      Description:

      Details

      Phase:Phase 1/Phase 2
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Bristol-Myers Squibb

      Last Updated

      April 12, 2017