A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Official Title

A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Summary:

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Trial Description

Primary Outcome:

• Incidence of adverse events (AE)
• Incidence of serious adverse events (SAE)
• Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria
• Incidence of AEs leading to discontinuation
• Incidence of deaths
• 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
• Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

• Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
• Median duration of response (mDOR) per response evaluation criteria in solid tumours (RECIST) v1.1
• Incidence of anti-drug antibody (ADA) to BMS-986253
• Serum biomarker concentration
• Maximum observed serum concentration (Cmax)
• Time of maximum observed serum concentration (Tmax)
• Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
• Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
• Observed serum concentration at the end of a dosing interval (CTAU)
• Trough observed serum concentration at the end of the dosing interval (CTROUGH)
• Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
• Overall Survival (OS)
• Incidence of AEs
• Incidence of SAEs
• 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

View this trial on ClinicalTrials.gov