Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumours (MK-5618-001)

Official Title

A Phase 1b Multi-centre Clinical Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumours.

Summary:

This study will examine the safety, pharmacokinetics, and efficacy of escalating doses of selumetinib (MK-5618) in combination with intravenous (IV) pembrolizumab (MK-3475) for participants with advanced / metastatic solid tumours.

Trial Description

Primary Outcome:

  • Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
  • Number of Participants Experiencing an Adverse Event (AE)
  • Number of Participants Discontinuing Study Treatment due to an Adverse Event
Secondary Outcome:
  • Area Under the Concentration-Time Curve (AUC) of Selumetinib
  • Maximum Observed Plasma Concentration (Cmax) of Selumetinib
  • Minimum Observed Plasma Concentration (Cmin) of Selumetinib

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