An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

Official Title

A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumours

Summary:

The purpose of this study is to assess the safety and tumour-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

Trial Description

Primary Outcome:

• Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths

• BMS-986179 enzyme assays in pre- and on-treatment biopsies
• BMS-986179 immunohistochemistry (IHC) in pre- and on-treatment biopsies
• Objective response rate (ORR)
• Duration of response (DOR)
• Progression free survival rate (PFSR)
• 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 the last quantifiable concentration [AUC(0-T)]
• Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
• Apparent terminal half-life (T-HALF)
• Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
• Effective elimination half-life (T-HALFeff)
• Concentration at the end of the dosing interval (Ctau)
• Trough observed serum concentration at the end of the dosing interval (Ctrough)
• Total body clearance (CLT)
• Volume of distribution at steady state (Vss)
• Accumulation index (AI)
• Apparent volume of distribution of terminal phase (Vz)
• Degree of fluctuation or fluctuation index (DF)
• Frequency of positive anti-drug antibody (ADA) to BMS-986179
• Frequency of positive anti-drug antibody (ADA) to nivolumab

View this trial on ClinicalTrials.gov