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 or in Combination With Nivolumab and/or Ipilimumab in Subjects With 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 participants with solid cancers that are advanced or have spread.

Trial Description

Primary Outcome:

• Incidence of AEs (adverse events)
• Incidence of SAEs (serious adverse events)
• Incidence of AEs leading to discontinuation
• Incidence of deaths
• Incidence of clinical laboratory test abnormalities - Blood
• Incidence of clinical laboratory test abnormalities - Blood Serum
• Incidence of clinical laboratory test abnormalities - Urinalysis
• Incidence of clinical laboratory test abnormalities - Serology

• Objective Response Rate (ORR)
• 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
• Immunogenicity assessed by number of participants with positive anti-drug antibodies (ADA) to BMS-986178
• Immunogenicity assessed by number of participants with positive ADA to nivolumab
• Immunogenicity assessed by number of participants with positive ADA to ipilimumab
• Number of participants showing a change in one of the pharmacodynamic biomarkers of BMS-986178 dosed in combo with nivolumab or nivolumab alone (Part 8) and sustained T cell expansion with DPV-001 in combo with nivolumab or nivolumab alone (Part 9)

View this trial on ClinicalTrials.gov