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

Titre officiel

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

Sommaire:

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

Description de l'essai

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)

Voir cet essai sur ClinicalTrials.gov

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