First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumours

Official Title

Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumours

Summary:

The purpose of this study is to determine whether BMS-986218 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 (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
• Objective Response Rate (ORR)
• Median Duration of Response (mDOR)
• Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

• ORR
• mDOR
• PFSR by RECIST v1.1
• Incidence of anti-drug antibody (ADA)
• Maximum observed plasma concentration (Cmax)
• Time of maximum observed plasma concentration (Tmax)
• Trough observed serum concentration (Ctrough)

View this trial on ClinicalTrials.gov