A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

Official Title

Phase Ib, Open-label, Multi-centre Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

Summary:

The purpose of this study is to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

Trial Description

Primary Outcome:

  • Frequency of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety
  • Changes between baseline and post-baseline laboratory parameters and vital signs.
  • Incidence of dose limiting toxicities (DLTs) of treatment (Escalation only)
  • Frequency of dose interruptions
  • Dose intensities
  • Severity of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of safety
  • Frequency of dose reductions
Secondary Outcome:
  • Key secondary: Histopathology of tumour infiltrating lymphocytes (TILs)
  • Changes from baseline in electrocardiogram (ECG) parameters
  • Best overall response (BOR)
  • Progression free survival (PFS) per irRC and RECIST v1.1
  • Treatment Free Survival (TFS)
  • Presence and/or concentration of anti-PDR001 antibodies.
  • Serum concentration of PDR001, canakinumab, CJM112
  • Plasma concentrations of trametinib and EGF816
  • Key secondary: Histopathology of myeloid cell infiltrate by IHC (such as CD8, FoxP3 and myeloid markers as appropriate).
  • PK parameters (Eg. TMax) of EGF816
  • PK parameters (Eg. TMax) of trametinib
  • PK parameter (Eg. TMax) of PDR001
  • PK parameters (Eg. TMax) of canakinumab
  • PK parameters (Eg. TMax) of CJM112
  • Presence and/or concentration of anti-canakinumab antibodies.
  • Presence and/or concentration of anti-CJM112 antibodies.

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