NCT04830124

Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma - ARTISTRY-6

A Phase 2, Open-Label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Mural Oncology, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma

Conditions

• Cutaneous Melanoma
• Mucosal Melanoma

Interventions

Type	Name	Description
DRUG	Nemvaleukin Alfa Subcutaneous	Subcutaneous injection of nemvaleukin every 7 days
DRUG	Nemvaleukin Alfa Intravenous	Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days
DRUG	Nemvaleukin Alfa Intravenous Less Frequent Dosing	Intravenous (IV) infusion over 30 minutes twice every 21 days (Day 1 and Day 8 dosing of a 21 day cycle)
DRUG	Pembrolizumab	Cohort 4 only: 200mg IV pembrolizumab on Day 1 of a 21-day cycle

Timeline

• Start date: 2021-09-27
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2021-04-02
• Last updated: 2025-06-10

Locations

41 sites across 8 countries: United States, Australia, Canada, Italy, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study