An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

Official Title

Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumours

Summary:

The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Trial Description

Primary Outcome:

  • Number of adverse events (AE)
  • Number of serious adverse events (SAE)
  • Number of AEs meeting dose limiting toxities criteria
  • Number of AEs leading to discontinuation
  • Number of AEs resulting in death
  • Incidence of clinical laboratory test abnormalities
  • Incidence of vital sign abnormalities
Secondary Outcome:
  • Objective response rate (ORR)
  • Disease control rate (DCR)
  • Median duration of response (mDOR)
  • Median progression-free survival (mPFS)
  • Progression-free survival (PFS)
  • Maximum observed blood concentration (Cmax)
  • Time of maximum observed blood concentration (Tmax)
  • Area under the blood concentration-time curve from time zero to time of last quanitifiable concentration [AUC(0-T)]
  • Area under the blood concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
  • Apparent terminal half-life (T-HALF)
  • Total body clearance (CLT)
  • Volume of distribution at steady-state (Vss)
  • Volume of distribution of the elimination phase (Vz)
  • Average plasma concentration over a dosing interval (AUC[0-48]/48) (Css-avg)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society