Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6 (ARTISTRY-6)

  • STATUS
    Recruiting
  • End date
    Sep 18, 2025
  • participants needed
    110
  • sponsor
    Alkermes, Inc.
Updated on 18 May 2022
metastatic melanoma
BRAF
pembrolizumab
targeted therapy
immunologic adjuvant
cytotoxic t-lymphocyte antigen 4
mucosal melanoma
malignant melanoma of skin

Summary

This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy

Details
Condition Cutaneous Melanoma, Mucosal Melanoma
Treatment Nemvaleukin Alfa Subcutaneous, Nemvaleukin Alfa Intravenous
Clinical Study IdentifierNCT04830124
SponsorAlkermes, Inc.
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The patient must have advanced cutaneous melanoma or acral melanoma; no more than 5 patients with acral melanoma may enroll in this cohort (Cohort 1). Or, the patient must have unresectable and/or metastatic mucosal melanoma (Cohort 2)
The patient must have received previous treatment as follows
Patient has received anti-PD-[L]1 therapy with or without anti-CTLA-4 therapy, and no more than one other prior regimen of systemic anti-neoplastic therapy (eg, targeted therapy, chemotherapy). Previous adjuvant and/or neoadjuvant therapy counts as one prior regimen
Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue
Patients have experienced objective response (partial response [PR] or CR; by RECIST 1.1 or iRECIST) or stable disease (SD; by RECIST 1.1 or iRECIST) as best overall response (BOR) to anti-PD-[L]1 therapy. Patients with confirmed progressive disease (by RECIST 1.1 or iRECIST) as best response may be included, if they received anti-PD-[L]1 therapy for a minimum of 12 weeks (eg, 4 doses of pembrolizumab every 3 weeks)
Patients with BRAF mutations may or may not have received prior targeted therapy
Patients must have disease that is measurable based on RECIST 1.1., that has not
Additional criteria may apply
recently been irradiated or used to collect a biopsy
Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy of ≥3 months

Exclusion Criteria

Patient has uveal melanoma
Patient requires systemic corticosteroids (>10 mg of prednisone daily, or equivalent) however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant
Patient is currently pregnant, breastfeeding, or is planning to become pregnant or to begin breastfeeding during the study period or within 30 days after last study drug administration
Patients with active or symptomatic central nervous system metastases unless the metastases have been treated by surgery and/or radiation therapy and/or gamma knife, the subject has been tapered to a dose of 10 mg of prednisone (or equivalent) or less of corticosteroids for at least 2 weeks before the first dose, and the subject is neurologically stable. Patients with leptomeningeal disease are excluded
Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof
Patient has known or suspected hypersensitivity to any components of nemvaleukin
Patients with an uncontrollable bleeding disorder
Patient has QT interval corrected by the Fridericia Correction Formula values of >470 msec (in females) or >450 msec (in males); patient who is known to have congenital prolonged QT syndromes; or patient who is on medications known to cause prolonged QT interval on ECG
Additional criteria may apply
Patient has developed Grade ≥3 immune-related AEs (irAEs) while on prior immunotherapy, (eg, pneumonitis, nephritis, and neuropathy)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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