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

Titre officiel

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

Sommaire:

Étude visant à déterminer l’innocuité et la capacité à réduire la taille des tumeurs du médicament expérimental BMS-986178 administré seul ou en association avec le nivolumab et/ou l’ipilimumab chez des patients atteints de cancers solides au stade avancé ou qui se sont propagés.

Description de l'essai

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 - Hematology
  • Incidence of clinical laboratory test abnormalities - Chemistry
  • Incidence of clinical laboratory test abnormalities - Urinalysis
  • Incidence of clinical laboratory test abnormalities - Serology
Secondary Outcome:
  • 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 combination with nivo or nivo alone (Part 8) and sustained T cell expansion with DPV-001 in combination with nivo with or without BMS-986178 (Part 9)

Voir cet essai sur ClinicalTrials.gov

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