A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumours (MK-0482-001)

Official Title

A Phase 1b, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0482 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumours.

Summary:

This is a dose escalation study to determine the safety and pharmacokinetics of MK-0482 as monotherapy and in combination with pembrolizumab (MK-3475) in participants with advanced solid tumours for which there is no available therapy which may convey clinical benefit.

Trial Description

Primary Outcome:

  • Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
  • Number of Participants Who Experience at Least One Adverse Event (AE)
  • Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Secondary Outcome:
  • Minimum Serum Concentration (Cmin) of MK-0482 When Administered as Monotherapy
  • Minimum Serum Concentration (Cmin) of MK-0482 When Administered in Combination with Pembrolizumab
  • Maximum Serum Concentration (Cmax) of MK-0482 When Administered as Monotherapy
  • Maximum Serum Concentration (Cmax) of MK-0482 When Administered in Combination with Pembrolizumab
  • Area Under the Concentration-Time Curve (AUC) of MK-0482 When Administered as Monotherapy
  • Area Under the Concentration-Time Curve (AUC) of MK-0482 When Administered in Combination with Pembrolizumab

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society