NCT04068181

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Talimogene laherparepvec	Intralesional injection into injectable cutaneous, subcutaneous and nodal legions.
DRUG	Pembrolizumab	Intravenous (IV) infusion.

Timeline

• Start date: 2020-01-22
• Primary completion: 2021-08-19
• Completion: 2024-02-26
• First posted: 2019-08-28
• Last updated: 2025-01-07
• Results posted: 2022-09-09

Locations

46 sites across 11 countries: United States, Australia, Canada, France, Germany, Greece, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study