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

Cutaneous Melanoma Clinical Trial

— ARTISTRY-6  

Official title:

A Phase 2, Open Label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]-1 Therapy - ARTISTRY-6

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830124
• Other study ID #: ALKS 4230-006
• Status: Recruiting
• Phase: Phase 2
• Start date: May 27, 2021
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Mural Oncology, Inc
• Contact: Senior Director, Global Clinical Services
• Phone: 888-235-8008 (US Only)
• Email: clinicaltrials[@]muraloncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: September 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. 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.

2. 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).

3. 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 (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.

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma
• Mucosal Melanoma
• Skin Neoplasms

Intervention

Drug:
• 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 once every 21 days or twice every 21 days

Locations

Country	Name	City	State
Australia	Mural Oncology Investigator Site	Tugun	Queensland
Australia	Mural Oncology Investigator Site	Waratah	New South Wales
Australia	Mural Oncology Investigator Site	Woodville
Canada	Mural Oncology Investigator Site	Montreal	Quebec
Canada	Mural Oncology Investigator Site	Montréal	Quebec
Canada	Mural Oncology Investigator Site	Toronto	Ontario
Italy	Mural Oncology Investigator Site	Milano
Italy	Mural Oncology Investigator Site	Padova
Italy	Mural Oncology Investigator Site	Perugia
Italy	Mural Oncology Investigator Site	Siena
Korea, Republic of	Mural Oncology Investigator Site	Daegu
Korea, Republic of	Mural Oncology Investigator Site	Daejeon
Korea, Republic of	Mural Oncology Investigator Site	Gangam-gu	Seoul
Korea, Republic of	Mural Oncology Investigator Site	Jongno-gu	Seoul
Korea, Republic of	Mural Oncology Investigator Site	Seoul	Seocho-gu
Korea, Republic of	Mural Oncology Investigator Site	Seoul	Seocho-gu
Korea, Republic of	Mural Oncology Investigator Site	Songpa-Gu	Seoul
Spain	Mural Oncology Investigator Site	Barcelona
Spain	Mural Oncology Investigator Site	Madrid
Spain	Mural Oncology Investigator Site	Madrid
Spain	Mural Oncology Investigator Site	Málaga
Spain	Mural Oncology Investigator Site	Zaragoza
Taiwan	Mural Oncology Investigator Site	Kaohsiung
Taiwan	Mural Oncology Investigator Site	Taipei
Taiwan	Mural Oncology Investigator Site	Taoyuan
United Kingdom	Mural Oncology Investigator Site	London
United Kingdom	Mural Oncology Investigator Site	Manchester
United Kingdom	Mural Oncology Investigator Site	Oxford
United States	Mural Oncology Investigator Site	Boston	Massachusetts
United States	Mural Oncology Investigator Site	Boston	Massachusetts
United States	Mural Oncology Investigator Site	Dallas	Texas
United States	Mural Oncology Investigator Site	Jacksonville	Florida
United States	Mural Oncology Investigator Site	La Jolla	California
United States	Mural Oncology Investigator Site	Los Angeles	California
United States	Mural Oncology Investigator Site	Louisville	Kentucky
United States	Mural Oncology Investigator Site	New York	New York
United States	Mural Oncology Investigator Site	New York	New York
United States	Mural Oncology Investigator Site	New York	New York
United States	Mural Oncology Investigator Site	Orlando	Florida
United States	Mural Oncology Investigator Site	Rochester	Minnesota
United States	Mural Oncology Investigator Site	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mural Oncology, Inc

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Centrally-assessed overall response rate (ORR) (Cohort 1 and 2)	ORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug; Response will be based on RECIST v1.1 criteria	Assessed up to 2 years from the first dose
Primary	Investigator-assessed overall response rate (ORR) (Cohort 3)	ORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug	Assessed up to 2 years from the first dose
Secondary	Centrally-assessed duration of response (DOR) (Cohort 1 and 2)	-DOR is defined as the time from the first documentation of complete or partial response to the first documentation of either objective tumor progression or death	Assessed up to 2 years from the first dose
Secondary	Centrally-assessed progression free survival (PFS) (Cohort 1 and 2)	-PFS is defined as the time from each respective patient's first dose of nemvaleukin to either the first documentation of objective tumor progression or death	Assessed up to 2 years from the first dose
Secondary	Centrally-assessed disease control rate (DCR) (Cohort 1 and 2)	-DCR is defined as the proportion of patients with objective evidence of complete response, partial response, or stable disease on 2 consecutive protocol-required disease assessments	Assessed up to 2 years from the first dose
Secondary	Centrally-assessed time to response (TTR) (Cohort 1 and 2)	-TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response	Assessed up to 2 years from the first dose
Secondary	Incidence of treatment-emergent adverse events (All cohorts)		Assessed up to 2 years from the first dose
Secondary	Investigator-assessed overall response rate (ORR) (Cohort 1 and 2)	ORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed duration of response (DOR) (All cohorts)	-DOR is defined as the time from the first documentation of complete or partial response to the first documentation of either objective tumor progression or death	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed progression free survival (PFS) (All cohorts)	-PFS is defined as the time from each respective patient's first dose of nemvaleukin to either the first documentation of objective tumor progression or death	Up to 2 years from the first dose
Secondary	Investigator-assessed disease control rate (DCR) (All cohorts)	-DCR is defined as the proportion of patients with objective evidence of complete response, partial response, or stable disease on 2 consecutive protocol-required disease assessments	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed time to response (TTR) (All cohorts)	-TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed immune overall response rate (iORR) (All cohorts)	-iORR is defined as the number of patients exhibiting a complete response (CR) or partial response (PR) divided by the number of patients who received the study drug.	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed immune duration of response (iDOR) (All cohorts)	-iDOR is defined as the time from the first documentation of complete or partial response to the first documentation of either objective tumor progression or death	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed immune progression free survival (iPFS) (All cohorts)	-iPFS is defined as the time from each respective patient's first dose of nemvaleukin to either the first documentation of objective tumor progression or death	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed immune disease control rate (iDCR) (All cohorts)	-iDCR is defined as the proportion of patients with objective evidence of complete response, partial response, or stable disease on 2 consecutive protocol-required disease assessments	Assessed up to 2 years from the first dose
Secondary	Investigator-assessed immune time to response (iTTR) (All cohorts)	-iTTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete or partial response	Assessed up to 2 years from the first dose