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

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ClinicalTrials.gov Identifier: NCT04830124
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

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

Condition or disease Intervention/treatment Phase
Cutaneous Melanoma Mucosal Melanoma Drug: Nemvaleukin Alfa Subcutaneous Drug: Nemvaleukin Alfa Intravenous Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]-1 Therapy - ARTISTRY-6
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Advanced Cutaneous Melanoma
Patients with unresectable and/or metastatic cutaneous melanoma
Drug: Nemvaleukin Alfa Subcutaneous
Subcutaneous injection of nemvaleukin every 7 days
Other Name: ALKS 4230 Subcutaneous

Experimental: Advanced mucosal melanoma
Patients with unresectable and/or metastatic mucosal melanoma
Drug: Nemvaleukin Alfa Intravenous
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days
Other Name: ALKS 4230 Intravenous




Primary Outcome Measures :
  1. Centrally-assessed overall response rate (ORR) [ Time Frame: Assessed up to 2 years from the first dose ]
    • 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


Secondary Outcome Measures :
  1. Centrally-assessed duration of response (DOR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  2. Centrally-assessed progression free survival (PFS) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  3. Centrally-assessed disease control rate (DCR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  4. Centrally-assessed time to response (TTR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response

  5. Incidence of treatment-emergent adverse events [ Time Frame: Assessed up to 2 years from the first dose ]
  6. Investigator-assessed overall response rate (ORR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  7. Investigator-assessed duration of response (DOR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  8. Investigator-assessed progression free survival (PFS) [ Time Frame: Up to 2 years from the first dose ]
    -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

  9. Investigator-assessed disease control rate (DCR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  10. Investigator-assessed time to response (TTR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response

  11. Investigator-assessed immune overall response rate (iORR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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.

  12. Investigator-assessed immune duration of response (iDOR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  13. Investigator-assessed immune progression free survival (iPFS) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  14. Investigator-assessed immune disease control rate (iDCR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -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

  15. Investigator-assessed immune time to response (iTTR) [ Time Frame: Assessed up to 2 years from the first dose ]
    -iTTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete or partial response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have advanced cutaneous melanoma or acral melanoma; no more than 5 patients with acral melanoma may enroll in this cohort (Cohort 1). Or, the patient must have unresectable and/or metastatic mucosal melanoma (Cohort 2).
  • Patient must have received previous treatment as follows: a) patient has received anti-PD-[L]1 therapy ± anti-CTLA-4 therapy, and ≤1 other prior regimen of systemic anti-neoplastic therapy; b) patient should have experienced objective response (PR or CR) or SD as BOR to anti-PD-[L]1 therapy; c) 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.
  • Patient has received prior IL-2-based or IL-15-based cytokine therapy.
  • 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, nephritis, and neuropathy).
  • Additional criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830124


Contacts
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Contact: Senior Director, Global Clinical Services 888-235-8008 (US Only) clinicaltrials@alkermes.com
Contact: Senior Director, Global Clinical Services 1-571-599-2702 (Global) clinicaltrials@alkermes.com

Locations
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United States, Kentucky
Alkermes Investigator Site Recruiting
Louisville, Kentucky, United States, 40018
United States, Minnesota
Alkermes Investigator Site Recruiting
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Carlos Mayo, MD Alkermes, Inc.
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT04830124    
Other Study ID Numbers: ALKS 4230-006
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkermes, Inc.:
Alkermes
ALKS 4230
Melanoma
Immunotherapy
Nemvaleukin alfa
IL-2
Interlukin-2
Oncology
Cytokine
Nemvaleukin
Additional relevant MeSH terms:
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Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases