A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumours

Official Title

A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumours

Summary:

This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.

Trial Description

Primary Outcome:

  • Adverse events (AEs)
  • Serious adverse events (SAEs)
  • AEs meeting protocol-defined dose limiting toxicity criteria
  • AEs leading to discontinuation
  • Death
  • Incidence of laboratory abnormalities
  • Electrocardiogram (ECG)
  • Summary measures of vital signs
  • Overall response rate (ORR)
  • Median duration of response (DOR)
  • Progression free survival (PFS) rate
  • Decrease in regulatory T cells (Treg) & tumour-associated macrophages (TAM) in tumour samples
Secondary Outcome:
  • Maximum observed plasma concentration (Cmax)
  • Time of maximum observed plasma concentration (Tmax)
  • Trough observed plasma concentration (Ctrough)
  • Observed plasma concentration at 24 hours post dose (C24)
  • Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)]
  • Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)]
  • Apparent total body clearance (CLT/F)
  • Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI)
  • Renal clearance (CLR)
  • Percent urinary recovery over 24 hours corrected for molecular weight (%UR)
  • Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax)
  • Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)]
  • Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy
  • Decrease in regulatory T cells (Treg) & tumour-associated macrophages (TAM) in tumour samples
  • Overall response rate (ORR)
  • Median duration of response (DOR)
  • Progression free survival (PFS) rate

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