An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

Official Title

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumours

Summary:

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumours

Trial Description

Primary Outcome:

  • Incidence of Adverse Events (AEs)
  • Incidence of Serious Adverse Events (SAEs)
  • Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
  • Incidence of AEs leading to discontinuation
  • Incidence of death
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
  • Incidence of treatment-related Grade 3-5 AEs
  • Objective Response Rate as assessed by investigator using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Secondary Outcome:
  • Cmax (Maximum observed serum concentration)
  • Tmax (Time of maximum observed concentration)
  • AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration)
  • AUC(TAU) (Area under the concentration-time curve in 1 dosing interval)
  • Ctau (Observed concentration at the end of a dosing interval)
  • Ctrough (Trough observed concentrations)
  • Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg)
  • Terminal serum half-life if data permit (T-HALF)
  • Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)]
  • Total body clearance (CLT)
  • Objective Response Rate (ORR)
  • Duration of response (DOR)
  • Progression-Free survival (PFS)
  • Time to response (TTR)
  • Incidence of Adverse Events (AEs) in Part 2 of Study
  • Incidence of Serious Adverse Events (SAEs) in Part 2 of Study
  • Incidence of AEs leading to discontinuation in Part 2 of study
  • Incidence of death in Part 2 of study
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests in Part 2 of study
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests in Part 2 of study
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests in Part 2 of study
  • Time to Deterioration (TTD) in Part 2 of study

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