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

Official Title

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

Summary:

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

Trial Description

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)

• 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

View this trial on ClinicalTrials.gov