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Cutaneous MelanomaPhase 2ARTISTRY-6NCT04830124

Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma - ARTISTRY-6

A Phase 2 study testing Nemvaleukin Alfa Subcutaneous, Nemvaleukin Alfa Intravenous and Nemvaleukin Alfa Intravenous Less Frequent Dosing in people with Cutaneous Melanoma and Mucosal Melanoma, run by Mural Oncology, Inc at 41 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cutaneous Melanoma, Mucosal Melanoma
What is being tested?
Nemvaleukin Alfa Subcutaneous, Nemvaleukin Alfa Intravenous and Nemvaleukin Alfa Intravenous Less Frequent Dosing
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
41 sitesin 8 countries
Study dates
27 Sep 2021to 8 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
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  • 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.

Who cannot join

  • Patient has uveal melanoma (all cohorts) or acral melanoma (Cohort 2, Cohort 3 and Cohort 4).
  • 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.
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  • 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.

Trial locations and contacts

41 sites in 8 countries.

41 sites in 8 countries

United States10 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UT Southwestern Medical Center of Dallas

    Dallas, Texas, 75390

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • Norton Cancer Center

    Louisville, Kentucky, 40018

  • NYU Laura and Isaac Perimutter Cancer Center

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Orlando Health, Inc

    Orlando, Florida, 32806

Other trials in United States

South Korea7 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, Daegu, 41404

  • Chungnam National University Hospital

    Daejeon, 35015

  • Samsung Medical Center

    Gangam-gu, Seoul, 06351

  • Seoul National University Hospital

    Jongno-gu, Seoul, 03080

  • The Catholic Univ. of Korea, Seoul St. Marys Hospital

    Seoul, Seocho-gu, 06591

  • Severance Hospital Yonsei University Health System

    Seoul, Seodaemun-Gu, 03722

  • Asan Medical Center

    Songpa-Gu, Seoul, 05505

Other trials in South Korea

Italy6 sites

  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

    Bari, 70124

  • Fondazione IRCC Istituto Nazionale dei Tumori

    Milan, 20133

  • Veneto Oncology Institute

    Padova, 35128

  • Ospedale S. Maria della Misericordia

    Perugia, 06132

  • IRCCS Istituti Fisioterapici Ospitalieri

    Roma, 144

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100

Other trials in Italy

Spain6 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035

  • Hospital Universitario Quiron Pozuelo

    Madrid, Madrid, 28223

  • Hospital General Universitario

    Madrid, 28007

  • Hospital Regional de Málaga

    Málaga, 29010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Australia3 sites

  • John Flynn Private Hospital

    Tugun, Queensland, 4224

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • The Queen Elizabeth Hospital

    Woodville, 5011

Other trials in Australia

Canada3 sites

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 1R9

  • McGill University Health Center (MUHC)

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Taiwan3 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Taipei Veterans General Hospital, VGHTPE

    Taipei, Taipei, 112

  • Chang Gung Memorial Hospital LinKou

    Taoyuan, 333

Other trials in Taiwan

United Kingdom3 sites

  • Royal Marsden Hospital

    London, SW3 6JJ

  • The Christie Hospital

    Manchester, M20 4BX

  • The Churchill Hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: A Phase 2, Open-Label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab 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

Being tested
Nemvaleukin Alfa Subcutaneous, Nemvaleukin Alfa Intravenous, Nemvaleukin Alfa Intravenous Less Frequent Dosing, Pembrolizumab
Keywords
ALKS 4230, Melanoma, Immunotherapy, Nemvaleukin alfa, IL-2, Interlukin-2, Oncology, Cytokine, Nemvaleukin, Mural Oncology, Pembrolizumab
Medical subject headings
Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nemvaleukin Alfa SubcutaneousDrug

    Also called ALKS 4230 Subcutaneous

    Subcutaneous injection of nemvaleukin every 7 days

  • Nemvaleukin Alfa IntravenousDrug

    Also called ALKS 4230 Intravenous

    Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days

  • Nemvaleukin Alfa Intravenous Less Frequent DosingDrug

    Also called ALKS 4230 Intravenous

    Intravenous (IV) infusion over 30 minutes twice every 21 days (Day 1 and Day 8 dosing of a 21 day cycle)

  • PembrolizumabDrug

    Also called Keytruda

    Cohort 4 only: 200mg IV pembrolizumab on Day 1 of a 21-day cycle

Study groups in NCT04830124
Study groupRoleWhat they receive
Advanced Cutaneous Melanoma Subcutaneous Dosing (Cohort 1)ExperimentalPatients with unresectable and/or metastatic cutaneous melanoma
Receives: Drug: Nemvaleukin Alfa Subcutaneous
Advanced mucosal melanoma with IV Dosing (Cohort 2)ExperimentalPatients with unresectable and/or metastatic mucosal melanoma
Receives: Drug: Nemvaleukin Alfa Intravenous
Advanced Cutaneous Melanoma with Less Frequent IV Dosing (Cohort 3)ExperimentalPatients with unresectable and/or metastatic cutaneous melanoma
Receives: Drug: Nemvaleukin Alfa Intravenous Less Frequent Dosing
Advanced Cutaneous Melanoma with Less Frequent IV Nemvaleukin Dosing + Pembrolizumab (Cohort 4)ExperimentalPatients 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.
Receives: Drug: Nemvaleukin Alfa Intravenous Less Frequent Dosing; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Assessed up to 2 years from the first dose

  2. Investigator-assessed overall response rate (ORR) (Cohort 3 and 4)

    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

    Measured: Assessed up to 2 years from the first dose

Secondary outcomes (15)

  1. 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

    Measured: Assessed up to 2 years from the first dose

  2. Investigator-assessed duration of response (DOR) (Cohort 3 and 4)

    -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

    Measured: Assessed up to 2 years from the first dose

  3. 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

    Measured: Assessed up to 2 years from the first dose

  4. Investigator-assessed progression free survival (PFS) (Cohort 3 and 4)

    -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

    Measured: Assessed up to 2 years from the first dose

  5. 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

    Measured: Assessed up to 2 years from the first dose

  6. Investigator-assessed disease control rate (DCR) (Cohort 3 and 4)

    -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

    Measured: Assessed up to 2 years from the first dose

  7. 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

    Measured: Assessed up to 2 years from the first dose

  8. Investigator-assessed time to response (TTR) (Cohort 3 and 4)

    -TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response

    Measured: Assessed up to 2 years from the first dose

  9. Incidence of treatment-emergent adverse events (All cohorts)

    Measured: Assessed up to 2 years from the first dose

  10. 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

    Measured: Assessed up to 2 years from the first dose

  11. 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.

    Measured: Assessed up to 2 years from the first dose

  12. 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

    Measured: Assessed up to 2 years from the first dose

  13. 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

    Measured: Assessed up to 2 years from the first dose

  14. 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

    Measured: Assessed up to 2 years from the first dose

  15. 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

    Measured: Assessed up to 2 years from the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2021
  2. Study start27 Sep 2021
  3. Primary completion8 May 2025
  4. Study completion8 May 2025

Why it stopped: Study terminated due to business and strategic decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04830124
Sponsor's protocol ID
ALKS 4230-006
Acronym
ARTISTRY-6
Status last verified
Jun 2025
First submitted
1 Apr 2021
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nemvaleukin Alfa Subcutaneous, Nemvaleukin Alfa Intravenous and Nemvaleukin Alfa Intravenous Less Frequent Dosing in people with Cutaneous Melanoma and Mucosal Melanoma, run by Mural Oncology, Inc at 41 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, South Korea, Italy, Spain, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to business and strategic decision.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Centrally-assessed overall response rate (ORR) (Cohort 1 and 2) (time frame: Assessed up to 2 years from the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04830124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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