Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients

Official Title

A Phase Ib Study of PDR001 in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

Summary:

A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.

Trial Description

Primary Outcome:

  • Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Secondary Outcome:
  • Pharmacokinetics (PK): Ctrough
  • Pharmacokinetics (PK): Cmax
  • Pharmacokinetics (PK): AUC
  • Overall response rate (ORR) using RECIST v1.1 criteria)
  • Progression free survival (PFS)
  • Time to Progression (TTP)
  • Duration of response (DOR)
  • Time to response (TTR)
  • Disease control rate (DCR) per RECIST v1.1
  • Overall survival (OS)
  • Antidrug antibodies (ADA) prevalence at baseline and on treatment

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