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

Summary:

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)

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