Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumours (MK-4830-001)

Official Title

A Phase 1 Open Label, Multi-Arm, Multicentre Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumours

Summary:

This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of MK-4830 administered as monotherapy and in combination with pembrolizumab (MK-3475) in participants with advanced solid tumours; determine the safety and tolerability for the combination of MK-4830 with pembrolizumab + carboplatin/pemetrexed in participants with non-small-cell lung carcinoma (NSCLC), and MK-4830 in combination with pembrolizumab + lenvatinib in renal cell cancer; and to evaluate objective response rate (ORR) in participants with advanced solid tumours treated with MK-4830 in combination with pembrolizumab.

Trial Description

Primary Outcome:

  • Dose-Limiting Toxicities (DLTs)
  • Adverse Events (AEs)
  • Study Treatment Discontinuations Due to AEs
  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as Assessed by Investigator
Secondary Outcome:
  • Area Under the Curve (AUC) of Plasma MK-4830
  • Minimum Drug Concentration (Cmin) of Plasma MK-4830
  • Maximum Drug Concentration (Cmax) of Plasma MK-4830

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