NCT04521621

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (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 gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
BIOLOGICAL	Gebasaxturev	Participants receive gebasaxturev intratumorally for 1 28-day cycle followed by 7 21-day cycles.
DRUG	Pembrolizumab	Participants receive pembrolizumab intravenously for 1 28-day cycle followed by 34 21-day cycles.

Timeline

• Start date: 2020-10-28
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2020-08-20
• Last updated: 2024-10-01
• Results posted: 2024-08-07

Locations

29 sites across 14 countries: United States, Canada, France, Germany, Hungary, Israel, Italy, Japan, Norway, Peru, Poland, Portugal, Spain, Taiwan

Regulatory

• FDA-regulated drug study