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 2 part study. Part 1 is a dose escalation to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) dose of MK-0482 administered 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. Part 2 is expansion cohort to determine safety and tolerability of MK-0482 in combination with pembrolizumab with and without chemotherapy in participants with advanced tumour specific cohorts.

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 (Part 1 only)
• Number of Participants Who Experience at Least One Adverse Event (AE)
• Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
• Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Part 2 only)

• Minimum Serum Concentration (Cmin) of MK-0482 When Administered as Monotherapy (Part 1 only)
• Cmin of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
• Maximum Serum Concentration (Cmax) of MK-0482 When Administered as Monotherapy (Part 1 only)
• Cmax of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
• Area Under the Concentration-Time Curve (AUC) of MK-0482 When Administered as Monotherapy (Part 1 only)
• AUC of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
• Objective Response Rate (ORR) As Assessed by Investigator per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) (Part 2 only)
• ORR As Assessed by Investigator per Response Assessment in Neuro-Oncology (RANO) (Part 2 only)

View this trial on ClinicalTrials.gov