An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

Official Title

A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Summary:

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab to participants with cancers that have failed to respond to or are known to be insensitive to T cell checkpoint inhibiting antibodies.

Trial Description

Primary Outcome:

• Number of Participants With Dose-Limiting Toxicities (DLTs)
• Number of Participants With an Adverse Event
• Number of Participants With a Serious Adverse Event
• Number of Participants With an AE leading to discontinuation of study treatment
• Number of Deaths
• Number of clinically significant changes in lab assessment of Blood
• Number of clinically significant changes in lab assessment of Blood Serum
• Number of clinically significant changes in lab assessment of Urine

• Maximum Observed Plasma Concentration (Cmax) of BMS - 986301 in Plasma
• Maximum Observed Plasma Concentration (Cmax) of BMS - 986301 in Urine
• Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS - 986301 in Plasma
• Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS - 986301 in Urine
• Area under the concentration-time curve in one dosing interval (24 h) of BMS - 986301 in Plasma
• Area under the concentration-time curve in one dosing interval (24 h) of BMS - 986301 in Urine
• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of BMS - 986301 in Plasma
• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of BMS - 986301 in Urine
• Change from Baseline in Levels and Activation of Tumour Infiltrating T Cells
• Change from baseline in Programmed Death-Ligand 1 (PD-L1) Expression Status in Tumours
• Change from Baseline in Blood Cytokines
• Change from Baseline in Peripheral Blood Mononuclear Cell (PBMC) gene expression
• Change from Baseline in Genetic Expression Profile (GEP) in injected and non-injected tumours

View this trial on ClinicalTrials.gov