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


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 Adverse Events (AEs), Serious AEs, AEs leading to Discontinuation and Deaths
  • Number of Participants With Clinically Significant Laboratory Abnormalities
Secondary Outcome:
  • Maximum Observed Plasma Concentration (Cmax) of BMS-986301
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-986301
  • Area under the concentration-time curve in one dosing interval (24 h) of BMS-986301
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of BMS-986301
  • Changes in Levels and Activation of Tumour Infiltrating T Cells
  • Change in Programmed Death-Ligand 1 (PD-L1) Expression Status in Tumours
  • BMS-986301-induced Changes in Cytokines in Blood and Tumours

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society