Clinical Trials /

An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

NCT02754141

Description:

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
  • Official Title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA013-004
  • SECONDARY ID: 2016-000603-91
  • NCT ID: NCT02754141

Conditions

  • Malignant Solid Tumor

Interventions

DrugSynonymsArms
BMS-986179Arm A-Monotherapy
NivolumabBMS-936558, OpdivoArm B- Combination Therapy
rHuPH20Arm C-Combination Therapy

Purpose

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Trial Arms

NameTypeDescriptionInterventions
Arm A-MonotherapyExperimentalBMS-986179, dose as specified
  • BMS-986179
Arm B- Combination TherapyExperimentalBMS-986179 + nivolumab, dose as specified
  • BMS-986179
  • Nivolumab
Arm C-Combination TherapyExperimentalBMS-986179 + rHuPH20, dose as specified
  • BMS-986179
  • rHuPH20

Eligibility Criteria

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

        Inclusion Criteria:

          -  Solid cancers that are advanced or have spread (for which alternative therapies were
             deemed not effective)

          -  Eastern Cooperative Oncology Group (ECOG) 0-1

          -  Acceptable lab testing results

          -  Allow biopsies

        Exclusion Criteria:

          -  Central nervous system (CNS) tumors

          -  Uncontrolled or significant cardiovascular diseases

          -  Active or known autoimmune disease

          -  Organ transplant

        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:Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:

Secondary Outcome Measures

Measure:The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies
Time Frame:Approximately 63 days
Safety Issue:
Description:
Measure:The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies
Time Frame:Approximately 63 days
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Progression free survival rate (PFSR)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Time of maximum observed serum concentration (Tmax)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Apparent terminal half-life (T-HALF)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Effective elimination half-life (T-HALFeff)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Concentration at the end of the dosing interval (Ctau)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Trough observed serum concentration at the end of the dosing interval (Ctrough)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Total body clearance (CLT)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Volume of distribution at steady state (Vss)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Accumulation index (AI)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Apparent volume of distribution of terminal phase (Vz)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Degree of fluctuation or fluctuation index (DF)
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Frequency of positive anti-drug antibody (ADA) to BMS-986179
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:
Measure:Frequency of positive anti-drug antibody (ADA) to nivolumab
Time Frame:Up to 100 days after the last dose of study drug
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated