NCT04135352

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (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, 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.

Detailed description

Due to discontinuation of V938-001, all ongoing participants who completed V938 plus pembrolizumab treatment may be enrolled in an extension study (KN587) to continue pembrolizumab monotherapy for a total of 35 cycles since the first dose in V938-001 and to be monitored as appropriate.

Conditions

• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	200 mg of pembrolizumab	Participants receive 200 mg of pembrolizumab intravenously Q3W for a maximum of 35 21-day cycles.
BIOLOGICAL	V938	Participants receive V938 intratumorally in cycles 1-7. Each cycle is 21 days.

Timeline

• Start date: 2019-11-04
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2019-10-22
• Last updated: 2024-11-12
• Results posted: 2024-11-12

Locations

6 sites across 3 countries: United States, Canada, Israel

Regulatory

• FDA-regulated drug study