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 Tumours

Summary:

The purpose of this study is to assess the safety and tumour-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 Description

Primary Outcome:

  • Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths
Secondary Outcome:
  • The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies
  • The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies
  • Objective response rate (ORR)
  • Duration of response (DOR)
  • Progression free survival rate (PFSR)
  • Maximum observed serum concentration (Cmax)
  • Time of maximum observed serum concentration (Tmax)
  • Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
  • Apparent terminal half-life (T-HALF)
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
  • Effective elimination half-life (T-HALFeff)
  • Concentration at the end of the dosing interval (Ctau)
  • Trough observed serum concentration at the end of the dosing interval (Ctrough)
  • Total body clearance (CLT)
  • Volume of distribution at steady state (Vss)
  • Accumulation index (AI)
  • Apparent volume of distribution of terminal phase (Vz)
  • Degree of fluctuation or fluctuation index (DF)
  • Frequency of positive anti-drug antibody (ADA) to BMS-986179
  • Frequency of positive anti-drug antibody (ADA) to nivolumab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society