A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumours

Official Title

A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumours

Summary:

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumour activity of BMS-986156 when administered alone and in combination with nivolumab in subjects with advanced solid tumours.

Trial Description

Primary Outcome:

  • Safety of BMS-986156 based on number of incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths in addition to clinical laboratory test abnormalities
Secondary Outcome:
  • Objective response rate (ORR)
  • Progression free survival rate (PFSR)
  • Duration of response
  • Maximum observed concentration (Cmax) of BMS-986156
  • Time of maximum observed concentration (Tmax) of BMS-986156
  • Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156
  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156
  • Anti-drug antibody (ADA) response to BMS-986156
  • Anti-drug antibody response to BMS-986156 and 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