Melanoma Clinical Trial

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

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

View Eligibility Criteria

Eligibility Criteria

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.
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 recently been irradiated or used to collect a biopsy.
Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue.
Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy of ≥3 months.
Additional criteria may apply.

Exclusion Criteria:

Patient has uveal melanoma.
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 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 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.
Patient has developed Grade ≥3 immune-related AEs (irAEs) while on prior immunotherapy, (eg, pneumonitis, nephritis, and neuropathy).
Additional criteria may apply.

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT04830124

Recruitment Status:

Recruiting

Sponsor:

Alkermes, Inc.

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There are 34 Locations for this study

See Locations Near You

Alkermes Investigational Site
La Jolla California, 92093, United States
Alkermes Investigator Site
Los Angeles California, 90025, United States
Alkermes Investigational Site
Jacksonville Florida, 32224, United States
Alkermes Investigator Site
Louisville Kentucky, 40018, United States
Alkermes Investigator Site
Boston Massachusetts, 02114, United States
Alkermes Investigator Site
Boston Massachusetts, 02215, United States
Alkermes Investigational Site
Rochester Minnesota, 55905, United States
Alkermes Investigator Site
Saint Paul Minnesota, 55101, United States
Alkermes Investigator Site
New York New York, 10016, United States
Alkermes Investigator Site
New York New York, 10032, United States
Alkermes Investigator Site
New York New York, 10065, United States
Alkermes Investigator Site
Waratah New South Wales, 2298, Australia
Alkermes Investigational Site
Woodville , 5011, Australia
Alkermes Investigator Site
Montreal Quebec, H2X 1, Canada
Alkermes Investigational Site
Montréal Quebec, H4A 3, Canada
Alkermes Investigational Site
Padova , 35128, Italy
Alkermes Investigational Site
Perugia , 06132, Italy
Alkermes Investigator Site
Siena , 53100, Italy
Alkermes Investigator Site
Seoul Seocho-gu, 03722, Korea, Republic of
Alkermes Investigator Site
Seoul Seocho-gu, 06591, Korea, Republic of
Alkermes Investigator Site
Gangam-gu Seoul, 06351, Korea, Republic of
Alkermes Investigator Site
Jongno-gu Seoul, 03080, Korea, Republic of
Alkermes Investigator Site
Songpa-Gu Seoul, 05505, Korea, Republic of
Alkermes Investigator Site
Daegu , 41404, Korea, Republic of
Alkermes Investigator Site
Daejeon , 35015, Korea, Republic of
Alkermes Investigator Site
Barcelona , 8035, Spain
Alkermes Investigator Site
Madrid , 28007, Spain
Alkermes Investigator Site
Madrid , 28223, Spain
Alkermes Investigator Site
Málaga , 29010, Spain
Alkermes Investigator Site
Kaohsiung , 83301, Taiwan
Alkermes Investigator Site
Taipei , 112, Taiwan
Alkermes Investigator Site
Taoyuan , 333, Taiwan
Alkermes Investigational Site
Manchester , M20 4, United Kingdom
Alkermes Investigator Site
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT04830124

Recruitment Status:

Recruiting

Sponsor:


Alkermes, Inc.

How clear is this clinincal trial information?

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