Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumours

Official Title

A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumours

Summary:

The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumours.

Trial Description

Primary Outcome:

• Incidence of adverse events (AEs)
• Incidence of serious adverse events (SAEs)
• Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria
• Incidence of adverse events (AEs) leading to discontinuation
• Number of deaths

• Objective Response Rate (ORR)
• Duration of Response (DOR)
• Progression-Free Survival Rate (PFSR)
• Maximum observed serum concentration (Cmax) of BMS-986315
• Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab
• Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab
• Time of maximum observed serum concentration (Tmax) of BMS-986315
• Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab
• Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab
• Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315
• Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab
• Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab
• Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315
• Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab
• Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab
• Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315
• Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab
• Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab
• Trough observed serum concentrations (Ctrough) of BMS-986315
• Incidence of anti-drug antibodies to BMS-986315
• Incidence of anti-drug antibodies to BMS-986315 with nivolumab
• Incidence of anti-drug antibodies to BMS-986315 with cetuximab

View this trial on ClinicalTrials.gov