An Investigational Immuno-therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Patients With Solid Cancers That Are Advanced or Have Spread

Official Title

A Phase 1/2a Study of BMS-986178 Administered Alone and in Combination With Nivolumab and/or Ipilimumab in Advanced Solid Tumours

Summary:

The purpose of the study is to determine the safety and tumour-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in patients with solid cancers that are advanced or have spread.

Trial Description

Primary Outcome:

• Incidence of AE's (adverse events) and SAE's (serious adverse events), AE's leading to discontinuation, deaths and clinical laboratory test abnormalities

• Cmax (maximum observed serum concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• Tmax (time of maximum observed concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• Ctau (the observed concentration at the end of a dosing interval) for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• CLT (total body clearance) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• Ctrough [trough observed plasma concentrations (this includes pre-dose concentrations (C0) and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
• Immunoassay of anti-nivolumab antibody in combination with anti-BMS- 986178 antibody
• Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody
• Objective Response Rate (ORR)
• Progression Free Survival Rate (PFSR)
• Immunoassay of anti-BMS-986178 antibody alone
• Number of participants showing a change in one of the pharmacodynamic biomarkers of BMS-986178 administered in combination with nivolumab

View this trial on ClinicalTrials.gov