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 (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

• 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

Voir cet essai sur ClinicalTrials.gov