A Study of Intratumoural/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies (V938-001)

Official Title

A Phase 1/1b, Open-label Clinical Study of Intratumoural/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies

Summary:

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and V938 shedding in participants with advanced/metastatic or recurrent malignancies who receive V938 in Combination with Pembrolizumab (MK-3475). The primary objective is to determine the safety and tolerability and to identify a recommended Phase 2 dose (RP2D) of V938 administered in combination with pembrolizumab.

Trial Description

Primary Outcome:

• Number of Participants Who Experience Dose-Limiting Toxicity (DLT)
• Number of Participants Who Experience ≥1 Adverse Event (AE)
• Number of Participants Who Discontinue Study Drug Due to an Adverse Event (AE)

• Objective Response Rate (ORR)
• Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) for V938 Ribonucleic Acid (RNA) in Plasma
• Maximum Concentration (Cmax) of V938 Ribonucleic Acid (RNA) Reached in Plasma
• V938 Excretion: Polymerase Chain Reaction (PCR)
• V938 Excretion: Infectivity

View this trial on ClinicalTrials.gov