Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Official Title

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer

Summary:

This is a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study will assess primarily the safety and tolerability and then the efficacy of PDR001 in combination with regorafenib. Particular attention will be paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis).

Trial Description

Primary Outcome Measures :

  • Incidence of Dose-limiting toxicity (DLT)
  • Overall Response Rate (ORR) per investigator assessment using RECIST v1.1
Secondary Outcome Measures :
  • Overall response rate (ORR) per central assessment using RECIST v1.1
  • Overall survival (OS)
  • Progression free survival (PFS)
  • Duration of response (DOR)
  • Time to response (TTR)
  • Cmax
  • Area under the curve (AUC)
  • Ctrough
  • Antidrug antibodies (ADA)

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