Nemvaleukin Alfa (ALKS 4230) in Advanced Cutaneous and Mucosal Melanoma
Research type
Research Study
Full title
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
IRAS ID
301384
Contact name
Mark Middleton
Contact email
Sponsor organisation
Alkermes, Inc.
Eudract number
2021-001557-31
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 17 days
Research summary
This research study is investigating the use of an experimental drug called nemvaleukin alfa (“nemvaleukin”) as a potential treatment for advanced cutaneous melanoma and advanced mucosal melanoma, in a population with limited treatment options. Nemvaleukin is a modified (manmade) molecule that binds to a protein known as interleukin-2 (IL-2) receptor, and has the potential of increasing the body’s immune (protective) system to destroy cancer cells. The main purpose of this study is to learn how well the study drug works and how safe the study drug is. This will be done by studying the way the body processes the study drug, how participants’ disease responds to the study drug and the body’s immune response to the study drug.
Approximately 110 participants are expected to take part in the study at around 40 sites globally. The study will involve 2 cohorts. Cohort 1 is designed to evaluate the safety and efficacy of subcutaneously-delivered (under the skin) nemvaleukin in participants with advanced cutaneous melanoma and Cohort 2 is designed to evaluate the safety and efficacy of intravenously-delivered (through the veins) nemvaleukin in participants with advanced mucosal melanoma.
This is an open-label study which means that all participants will be informed about the study drug being given and in this study all participants will be given the drug.
Participants will continue to receive nemvaleukin until, for example, they have an unacceptable side effect, their cancer has progressed or they choose to withdraw.
At the end of treatment, final tests and exams will be performed and the participants will be followed for up to 2 years after their first dose of nemvaleukin.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0013
Date of REC Opinion
18 Feb 2022
REC opinion
Further Information Favourable Opinion