Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma - ARTISTRY-6
NCT ID: NCT04830124
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
173 participants
INTERVENTIONAL
2021-09-27
2025-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Advanced Cutaneous Melanoma Subcutaneous Dosing (Cohort 1)
Patients with unresectable and/or metastatic cutaneous melanoma
Nemvaleukin Alfa Subcutaneous
Subcutaneous injection of nemvaleukin every 7 days
Advanced mucosal melanoma with IV Dosing (Cohort 2)
Patients with unresectable and/or metastatic mucosal melanoma
Nemvaleukin Alfa Intravenous
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days
Advanced Cutaneous Melanoma with Less Frequent IV Dosing (Cohort 3)
Patients with unresectable and/or metastatic cutaneous melanoma
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)
Advanced Cutaneous Melanoma with Less Frequent IV Nemvaleukin Dosing + Pembrolizumab (Cohort 4)
Patients with unresectable and/or metastatic cutaneous melanoma. Patients must not have received prior systemic anticancer therapy for unresectable or metastatic melanoma. Prior adjuvant and/or neoadjuvant PD-\[L\]1 treatments are allowed if there is at least 6 months between the last dose and date of recurrence.
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)
Pembrolizumab
Cohort 4 only: 200mg IV pembrolizumab on Day 1 of a 21-day cycle
Interventions
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Nemvaleukin Alfa Subcutaneous
Subcutaneous injection of nemvaleukin every 7 days
Nemvaleukin Alfa Intravenous
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days
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)
Pembrolizumab
Cohort 4 only: 200mg IV pembrolizumab on Day 1 of a 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Cohort 4: Patient has unresectable and/or metastatic cutaneous melanoma. No patients with mucosal or acral melanoma may enroll in this cohort.
\- The patient must have received previous treatment as follows: Cohorts 1 and 2: Patient has received anti-PD-\[L\]1 therapy with or without anti-CTLA-4 therapy, and less than or equal to 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.
Cohort 3: Patients who have received anti-PD-\[L\]1 therapy with or without anti-CTLA-4 therapy or anti-lymphocyte-activation gene 3 (LAG-3) therapy, and ≤1 other prior regimen of systemic anti-neoplastic therapy (eg, targeted therapy, chemotherapy). Previous adjuvant and/or neoadjuvant therapy counts as 1 prior regimen. Patients must have experienced objective response (PR or CR by RECIST 1.1 or iRECIST) or stable disease (by RECIST 1.1 or iRECIST) as 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 ≥12 weeks (from first dose to last dose). Patients with BRAF mutations may or may not have received prior targeted therapy.
Cohort 4: Patients must not have received prior systemic anticancer therapy for unresectable or metastatic melanoma. Prior adjuvant and/or neoadjuvant PD-\[L\]1 treatments are allowed if there is at least 6 months between the last dose and date of recurrence.
Cohorts 1, 2, and 3 - Patients who have received prior treatment with talimogene laherparepvec (TVEC) are allowed to enroll provided that last exposure to TVEC was ≥28 days prior to first exposure to nemvaleukin and that all injection-site reactions to TVEC have resolved. TVEC shall not be considered a prior regimen of systemic anti-neoplastic therapy, nor shall it be considered a systemic immunomodulatory agent.
* Patients must have disease that is measurable based on RECIST 1.1., that has not recently been irradiated or used to collect a biopsy.
* Cohorts 1 and 2 (required), Cohort 3 (optional), Cohort 4 (may be required, otherwise optional). Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue.
Cohort 4 - Patients are required to have known tumor PD-\[L\]1 status determined by local testing using an approved assay. PD-\[L\]1 testing performed prior to enrolling on the study is acceptable if there was no intervening systemic anti-cancer therapy, and archival tissue may be used for testing provided the biopsy is ≤3 months old.
* 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 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 (Cohorts 1,2, and 3) or 120 days (Cohort 4) 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 (all cohorts) or to pembrolizumab (cohort 4 only).
* 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.
* Cohort 4 only: Patient has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
* Additional criteria may apply.
18 Years
ALL
No
Sponsors
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Mural Oncology, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Mural Oncology Medical Monitor
Role: STUDY_DIRECTOR
Mural Oncology
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Orlando Health, Inc
Orlando, Florida, United States
Norton Cancer Center
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
NYU Laura and Isaac Perimutter Cancer Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UT Southwestern Medical Center of Dallas
Dallas, Texas, United States
Calvary Mater Newcastle
Waratah, New South Wales, Australia
John Flynn Private Hospital
Tugun, Queensland, Australia
The Queen Elizabeth Hospital
Woodville, , Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
McGill University Health Center (MUHC)
Montreal, Quebec, Canada
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, , Italy
Fondazione IRCC Istituto Nazionale dei Tumori
Milan, , Italy
Veneto Oncology Institute
Padua, , Italy
Ospedale S. Maria della Misericordia
Perugia, , Italy
IRCCS Istituti Fisioterapici Ospitalieri
Roma, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, , Italy
Kyungpook National University Chilgok Hospital
Daegu, Daegu, South Korea
The Catholic Univ. of Korea, Seoul St. Marys Hospital
Seoul, Seocho-gu, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seodaemun-Gu, South Korea
Samsung Medical Center
Gangam-gu, Seoul, South Korea
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Asan Medical Center
Songpa-Gu, Seoul, South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Hospital Universitario Quiron Pozuelo
Madrid, Madrid, Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario
Madrid, , Spain
Hospital Regional de Málaga
Málaga, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Taipei Veterans General Hospital, VGHTPE
Taipei, Taipei, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital LinKou
Taoyuan District, , Taiwan
Royal Marsden Hospital
London, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
The Churchill Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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ALKS 4230-006
Identifier Type: -
Identifier Source: org_study_id
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