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
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
Drug | Synonyms | Arms |
---|
Nemvaleukin Alfa Subcutaneous | ALKS 4230 Subcutaneous | Advanced Cutaneous Melanoma |
Nemvaleukin Alfa Intravenous | ALKS 4230 Intravenous | Advanced 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
Name | Type | Description | Interventions |
---|
Advanced Cutaneous Melanoma | Experimental | Patients with unresectable and/or metastatic cutaneous melanoma | - Nemvaleukin Alfa Subcutaneous
|
Advanced mucosal melanoma | Experimental | Patients 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