Melanoma Clinical Trial
Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma – ARTISTRY-6
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
The patient must have the following tumor types:
Cohort 1: Patient has unresectable and/or metastatic cutaneous melanoma. No more than 5 patients with acral melanoma may enroll in this cohort.
Cohort 2: Patient has unresectable and/or metastatic mucosal melanoma.
Cohort 3: Patient has unresectable and/or metastatic cutaneous melanoma. Patients with acral melanoma may not enroll in this cohort.
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, from first dose to last dose).
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.
Patient has uveal melanoma (all cohorts) or acral melanoma (Cohort 2 and Cohort 3).
Patient has received prior interleukin (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 and nephritis) and has not recovered to ≤Grade 1 and/or are on systemic steroids within 14 days of first dose of study drug.
Patients who have previously discontinued immunotherapy due to immune-related adverse event (irAEs) will be excluded.
Additional criteria may apply.
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There are 40 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90025, United States
Jacksonville Florida, 32224, United States
Louisville Kentucky, 40018, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Saint Paul Minnesota, 55101, United States
New York New York, 10016, United States
New York New York, 10032, United States
New York New York, 10065, United States
Dallas Texas, 75390, United States
Waratah New South Wales, 2298, Australia
Tugun Queensland, 4224, Australia
Woodville , 5011, Australia
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H2X 1, Canada
Montréal Quebec, H4A 3, Canada
Milano , 20133, Italy
Padova , 35128, Italy
Perugia , 06132, Italy
Siena , 53100, Italy
Seoul Seocho-gu, 03722, Korea, Republic of
Seoul Seocho-gu, 06591, Korea, Republic of
Gangam-gu Seoul, 06351, Korea, Republic of
Jongno-gu Seoul, 03080, Korea, Republic of
Songpa-Gu Seoul, 05505, Korea, Republic of
Daegu , 41404, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Barcelona , 8035, Spain
Madrid , 28007, Spain
Madrid , 28223, Spain
Málaga , 29010, Spain
Zaragoza , 50009, Spain
Kaohsiung , 83301, Taiwan
Taipei , 112, Taiwan
Taoyuan , 333, Taiwan
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
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