A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumours

Official Title

A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumours

Summary:

The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumour activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select 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 AEs leading to death
• Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)

• Maximum observed serum concentration (Cmax) of BMS-986416
• Time of maximum observed serum concentration (Tmax) of BMS-986416
• Trough observed serum concentration (Ctrough) of BMS-986416
• Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) per Investigator assessment
• Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
• Incidence of clinically significant changes in ECG parameters: QTcF

View this trial on ClinicalTrials.gov