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 or Response Assessment in Neuro-Oncology (RANO) as Assessed by Investigator

• 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