NCT02263508

Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma

A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 713 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma. The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and overall survival (OS).

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Talimogene Laherparepvec	Talimogene laherparepvec administered by intratumoral injection
DRUG	Pembrolizumab	Administered at a dose of 200 mg as an intravenous infusion over approximately 30 minutes.
DRUG	Placebo	Administered by intratumoral injection

Timeline

• Start date: 2014-12-08
• Primary completion: 2021-03-11
• Completion: 2021-03-11
• First posted: 2014-10-13
• Last updated: 2022-11-14
• Results posted: 2022-05-16

Locations

161 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Russia, South Africa, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study