Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC

Official Title

A Phase Ib/II, Open-label, Multi-centre Study of INC280 in Combination With PDR001 or PDR001 Single Agent in Advanced Hepatocellular Carcinoma.


The purpose of this study of INC280 and PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumour activity of PDR001 administered i.v. as a single agent or in combination with INC280 administered orally in adult patients with advanced hepatocellular carcinoma (HCC).

Trial Description

Primary Outcome:

  • Number of participants with Dose Limiting Toxicities (DLTs)
  • Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST v1.1)
Secondary Outcome:
  • Best overall response (BOR)
  • Duration of overall response (DOR)
  • Time to response (TTR)
  • Progression-free survival (PFS)
  • Time to progression (TTP)
  • Overall survival (OS)
  • Overall response rate (ORR)
  • Tiime to progression (TTP)
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) (INC280)
  • PK: Area under the serum concentration versus time curve (AUC) (PDR001)
  • PK: Plasma concentration vs. time profiles (INC280)
  • PK:Serum concentration vs. time profiles (PDR001)
  • PK: Peak Plasma Concentration (Cmax) (INC280)
  • PK:Time of Maximum concentration observed (Tmax) (INC280)
  • PK: Peak Serum Concentration (Cmax) (PDR001)
  • PK: Time of Maximum concentration observed (Tmax) (PDR001)

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Canadian Cancer Society

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