A Study of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumours (V937-013)

Official Title

A Phase 1b/2 Clinical Study of Intratumoural Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumours

Summary:

The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive V937 in Combination with Pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of V937 administered in combination with pembrolizumab.

Trial Description

Primary Outcome:

• Part 1: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as Assessed by Investigator
• Number of Participants who Experience a Dose-Limiting Toxicity (DLT)
• Part 2: Number of Participants Who Experienced One or More Adverse Events (AEs)
• Part 2: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

• Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)
• Part 1: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
• Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as Assessed by Investigator
• Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as Assessed by Investigator
• Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumours 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator
• Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumours 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator
• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator
• Overall Survival (OS)
• Solid Tumours+Liver Metastases Arms: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as Assessed by Investigator

View this trial on ClinicalTrials.gov