Clinical Trials /

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

NCT04830124

Description:

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

Related Conditions:
  • Acral Lentiginous Melanoma
  • Cutaneous Melanoma
  • Mucosal Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: ALKS 4230-006
  • NCT ID: NCT04830124

Conditions

  • Cutaneous Melanoma
  • Mucosal Melanoma

Interventions

DrugSynonymsArms
Nemvaleukin Alfa SubcutaneousALKS 4230 SubcutaneousAdvanced Cutaneous Melanoma
Nemvaleukin Alfa IntravenousALKS 4230 IntravenousAdvanced mucosal melanoma

Purpose

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 Arms

NameTypeDescriptionInterventions
Advanced Cutaneous MelanomaExperimentalPatients with unresectable and/or metastatic cutaneous melanoma
  • Nemvaleukin Alfa Subcutaneous
Advanced mucosal melanomaExperimentalPatients with unresectable and/or metastatic mucosal melanoma
  • Nemvaleukin Alfa Intravenous

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Centrally-assessed overall response rate (ORR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description: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

Measure:Centrally-assessed duration of response (DOR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Centrally-assessed progression free survival (PFS)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Centrally-assessed disease control rate (DCR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Centrally-assessed time to response (TTR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response
Measure:Incidence of treatment-emergent adverse events
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:
Measure:Investigator-assessed overall response rate (ORR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Investigator-assessed duration of response (DOR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Investigator-assessed progression free survival (PFS)
Time Frame:Up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Investigator-assessed disease control rate (DCR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Investigator-assessed time to response (TTR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-TTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete response or partial response
Measure:Investigator-assessed immune overall response rate (iORR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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.
Measure:Investigator-assessed immune duration of response (iDOR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Investigator-assessed immune progression free survival (iPFS)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Investigator-assessed immune disease control rate (iDCR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-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
Measure:Investigator-assessed immune time to response (iTTR)
Time Frame:Assessed up to 2 years from the first dose
Safety Issue:
Description:-iTTR is defined as the time from patient's first dose of nemvaleukin to the first documentation of complete or partial response

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Alkermes, Inc.

Trial Keywords

  • Alkermes
  • ALKS 4230
  • Melanoma
  • Immunotherapy
  • Nemvaleukin alfa
  • IL-2
  • Interlukin-2
  • Oncology
  • Cytokine
  • Nemvaleukin

Last Updated

June 10, 2021