A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumours

Titre officiel

A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumours

Sommaire:

L’objectif de cette étude consiste à évaluer le produit BMS-986226 administré seul ou en association avec le nivolumab ou l’ipilimumab.

Description de l'essai

Primary Outcome:

  • Incidence of adverse events (AE)
  • Incidence of serious adverse events (SAE)
  • Incidence of AE due to discontinuation
  • Incidence of AE resulting in death
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
  • Incidence of clinical laboratory test abnormalities graded according to common terminology criteria for adverse events (CTCAE)
Secondary Outcome:
  • Objective response rate (ORR) measure by Clopper-Pearson method
  • Median Duration of Response (mDOR) measured by Kaplan-Meier method
  • Progression Free Survival (PFS) measured by Kaplan-Meier method
  • Maximum observed plasma concentration (Cmax)
  • Time of maximum observed plasma concentration (Tmax)
  • Area under the concentration-time curve from time 0 to the time of the last [AUC (0-T)]
  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
  • Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay
  • Change from baseline in immunoassay for BMS-986226

Voir cet essai sur ClinicalTrials.gov

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