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


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 (AE)
  • Incidence of Serious Adverse Events (SAE)
  • Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
  • Incidence of AEs leading to discontinuation
  • Incidence of death
  • Incidence of Laboratory abnormalities
  • 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) of BMS-986249
  • Tmax (Time of maximum observed concentration) of BMS-986249
  • AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) of BMS-986249
  • AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) of BMS-986249
  • Ctau (Observed concentration at the end of a dosing interval) of BMS-986249
  • Ctrough (Trough observed concentrations) of BMS-986249
  • Objective Response Rate (ORR)
  • Duration of response (DOR)
  • Progression-Free survival (PFS)
  • Time to response (TTR)
  • Total body clearance (CLT) of BMS-986249
  • Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) of BMS-986249
  • Terminal serum half-life if data permit (T-HALF) of BMS-986249
  • Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] of BMS-986249
  • Incidence of Adverse Events (AE) in Part 2 of Study
  • Incidence of Serious Adverse Events (SAEs)
  • Incidence of AEs leading to discontinuation in Part 2 of study
  • Incidence of Deaths
  • Incidence of laboratory abnormalities
  • Time to Deterioration (TTD)

View this trial on

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.


Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society