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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04830124




Registration number
NCT04830124
Ethics application status
Date submitted
1/04/2021
Date registered
2/04/2021
Date last updated
20/03/2024

Titles & IDs
Public title
Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6
Scientific 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
Secondary ID [1] 0 0
ALKS 4230-006
Universal Trial Number (UTN)
Trial acronym
ARTISTRY-6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Melanoma 0 0
Mucosal Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nemvaleukin Alfa Subcutaneous
Treatment: Drugs - Nemvaleukin Alfa Intravenous
Treatment: Drugs - Nemvaleukin Alfa Intravenous Less Frequent Dosing

Experimental: Advanced Cutaneous Melanoma Subcutaneous Dosing (Cohort 1) - Patients with unresectable and/or metastatic cutaneous melanoma

Experimental: Advanced mucosal melanoma with IV Dosing (Cohort 2) - Patients with unresectable and/or metastatic mucosal melanoma

Experimental: Advanced Cutaneous Melanoma with Less Frequent IV Dosing (Cohort 3) - Patients with unresectable and/or metastatic cutaneous melanoma


Treatment: Drugs: Nemvaleukin Alfa Subcutaneous
Subcutaneous injection of nemvaleukin every 7 days

Treatment: Drugs: Nemvaleukin Alfa Intravenous
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days

Treatment: Drugs: Nemvaleukin Alfa Intravenous Less Frequent Dosing
Intravenous (IV) infusion over 30 minutes once every 21 days or twice every 21 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Centrally-assessed overall response rate (ORR) (Cohort 1 and 2)
Timepoint [1] 0 0
Assessed up to 2 years from the first dose
Primary outcome [2] 0 0
Investigator-assessed overall response rate (ORR) (Cohort 3)
Timepoint [2] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [1] 0 0
Centrally-assessed duration of response (DOR) (Cohort 1 and 2)
Timepoint [1] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [2] 0 0
Centrally-assessed progression free survival (PFS) (Cohort 1 and 2)
Timepoint [2] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [3] 0 0
Centrally-assessed disease control rate (DCR) (Cohort 1 and 2)
Timepoint [3] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [4] 0 0
Centrally-assessed time to response (TTR) (Cohort 1 and 2)
Timepoint [4] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [5] 0 0
Incidence of treatment-emergent adverse events (All cohorts)
Timepoint [5] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [6] 0 0
Investigator-assessed overall response rate (ORR) (Cohort 1 and 2)
Timepoint [6] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [7] 0 0
Investigator-assessed duration of response (DOR) (All cohorts)
Timepoint [7] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [8] 0 0
Investigator-assessed progression free survival (PFS) (All cohorts)
Timepoint [8] 0 0
Up to 2 years from the first dose
Secondary outcome [9] 0 0
Investigator-assessed disease control rate (DCR) (All cohorts)
Timepoint [9] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [10] 0 0
Investigator-assessed time to response (TTR) (All cohorts)
Timepoint [10] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [11] 0 0
Investigator-assessed immune overall response rate (iORR) (All cohorts)
Timepoint [11] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [12] 0 0
Investigator-assessed immune duration of response (iDOR) (All cohorts)
Timepoint [12] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [13] 0 0
Investigator-assessed immune progression free survival (iPFS) (All cohorts)
Timepoint [13] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [14] 0 0
Investigator-assessed immune disease control rate (iDCR) (All cohorts)
Timepoint [14] 0 0
Assessed up to 2 years from the first dose
Secondary outcome [15] 0 0
Investigator-assessed immune time to response (iTTR) (All cohorts)
Timepoint [15] 0 0
Assessed up to 2 years from the first dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
176
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Mural Oncology Investigator Site - Waratah
Recruitment hospital [2] 0 0
Mural Oncology Investigator Site - Tugun
Recruitment hospital [3] 0 0
Mural Oncology Investigator Site - Woodville
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4224 - Tugun
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Padova
Country [12] 0 0
Italy
State/province [12] 0 0
Perugia
Country [13] 0 0
Italy
State/province [13] 0 0
Siena
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seocho-gu
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Daegu
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Daejeon
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Málaga
Country [21] 0 0
Spain
State/province [21] 0 0
Zaragoza
Country [22] 0 0
Taiwan
State/province [22] 0 0
Kaohsiung
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taipei
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taoyuan
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mural Oncology, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04830124
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carlos Mayo, MD
Address 0 0
Mural Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Senior Director, Global Clinical Services
Address 0 0
Country 0 0
Phone 0 0
888-235-8008 (US Only)
Fax 0 0
Email 0 0
clinicaltrials@muraloncology.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04830124