NCT04152863

Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.

Conditions

• Advanced/Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Gebasaxturev IV	Administered as an IV infusion of 1 X 10\^9 TCID50
BIOLOGICAL	Gebasaxturev ITu	Administered as an ITu injection of 3 X 10\^8 TCID50
DRUG	Pembrolizumab	Administered as an IV infusion of 200 mg

Timeline

• Start date: 2020-06-05
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2019-11-05
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

30 sites across 11 countries: United States, Australia, Chile, France, Germany, Israel, Italy, Norway, South Africa, South Korea, Spain

Regulatory

• FDA-regulated drug study