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

Titre officiel

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.

Sommaire:

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.

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov

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