An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

Official Title

A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Summary:

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab to participants with cancers that have failed to respond to or are known to be insensitive to T cell checkpoint inhibiting antibodies.

Trial Description

Primary Outcome:

  • Number of Participants With Dose-Limiting Toxicities (DLTs)
  • Number of Participants With an Adverse Event
  • Number of Participants With a Serious Adverse Event
  • Number of Participants With an AE leading to discontinuation of study treatment
  • Number of Deaths
  • Number of clinically significant changes in lab assessment of Blood
  • Number of clinically significant changes in lab assessment of Blood Serum
  • Number of clinically significant changes in lab assessment of Urine
Secondary Outcome:
  • Maximum Observed Plasma Concentration (Cmax) of BMS - 986301 in Plasma
  • Maximum Observed Plasma Concentration (Cmax) of BMS - 986301 in Urine
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS - 986301 in Plasma
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS - 986301 in Urine
  • Area under the concentration-time curve in one dosing interval (24 h) of BMS - 986301 in Plasma
  • Area under the concentration-time curve in one dosing interval (24 h) of BMS - 986301 in Urine
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of BMS - 986301 in Plasma
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of BMS - 986301 in Urine
  • Change from Baseline in Levels and Activation of Tumour Infiltrating T Cells
  • Change from baseline in Programmed Death-Ligand 1 (PD-L1) Expression Status in Tumours
  • Change from Baseline in Blood Cytokines
  • Change from Baseline in Peripheral Blood Mononuclear Cell (PBMC) gene expression
  • Change from Baseline in Genetic Expression Profile (GEP) in injected and non-injected tumours

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