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 has dose escalation (Part A, B, C) and dose expansion (Cohorts A-L) parts. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Parts A and B) and in combination with pembrolizumab (Part C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab and evaluate the safety, tolerability and ORR of MK-4830 administered in combination with pembrolizumab and chemotherapy. There is no formal hypothesis testing in this study.

Trial Description

Primary Outcome:

• Dose-Limiting Toxicities (DLTs)
• Number of Participants Who Experienced an Adverse Event (AE)
• Number of Participants Who Discontinued Study Treatment Due to an AE
• 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
• ORR per Modified RECIST (mRECIST) 1.1 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