An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread.

Official Title

A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumours

Summary:

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

Trial Description

Primary Outcome:

  • Safety and tolerability of BMS-986205 as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
  • Safety of BMS-986205 plus nivolumab as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
  • Safety of BMS-986205 plus both nivolumab and ipilimumab as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
  • Anti-tumour activity of BMS 986205 administered in combination with nivolumab as measured by the best overall response (BOR)
  • Anti-tumour activity of BMS 986205 administered in combination with nivolumab as measured by the duration of response (DOR)
  • Anti-tumour activity of BMS 986205 administered in combination with nivolumab as measured by progression-free survival rates (PFSRs)
  • Anti-tumour activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the best overall response (BOR)
  • Anti-tumour activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the duration of response (DOR)
  • Anti-tumour activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by progression-free survival rates (PFSRs)
Secondary Outcome:
  • Maximum observed plasma concentration (Cmax) of BMS-986205
  • Time of maximum observed plasma concentration (Tmax) of BMS-986205
  • Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205
  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205
  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205
  • Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205
  • Observed plasma concentration at 24 hours (C24) of BMS-986205
  • Apparent terminal phase half-life (T-HALF) of BMS-986205
  • Apparent total body clearance (CLT/F) of BMS-986205
  • Apparent renal clearance (CLR/F) of BMS-986205
  • Volume of distribution of terminal phase (Vz/F) of BMS-986205
  • Apparent volume of distribution at steady state (Vss/F) of BMS-986205
  • Accumulation index (AI) of BMS-986205
  • Percent urinary recovery (%UR) of BMS-986205
  • Percent urinary recovery over 24 hours(%UR24) of BMS-986205
  • Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205
  • Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205
  • Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205
  • Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205
  • Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205
  • Anti-drug antibody (ADA) response to Ipilimumab in combination with BMS-986205

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society