TERMINATED

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

Talk to us

Conditions

Cutaneous MelanomaMucosal MelanomaALKS 4230MelanomaImmunotherapyNemvaleukin alfaIL-2Interlukin-2OncologyCytokineNemvaleukinMural OncologyPembrolizumab

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-09-27
Study Completion:2025-05-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04830124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The patient must have the following tumor types:
  2. * Patients must have disease that is measurable based on RECIST 1.1., that has not recently been irradiated or used to collect a biopsy.
  3. * 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.
  4. * Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy of ≥3 months.
  5. * Additional criteria may apply.
  1. * Patient has uveal melanoma (all cohorts) or acral melanoma (Cohort 2, Cohort 3 and Cohort 4).
  2. * 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.
  3. * Patient requires systemic corticosteroids (\>10 mg of prednisone daily, or equivalent) however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
  4. * Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant.
  5. * 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.
  6. * 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.
  7. * Patient has known or suspected hypersensitivity to any components of nemvaleukin (all cohorts) or to pembrolizumab (cohort 4 only).
  8. * Patients with an uncontrollable bleeding disorder.
  9. * 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.
  10. * 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.
  11. * Patients who have previously discontinued immunotherapy due to immune-related adverse event (irAEs) will be excluded.
  12. * Cohort 4 only: Patient has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
  13. * Additional criteria may apply.

Contacts and Locations

Principal Investigator

Mural Oncology Medical Monitor
STUDY_DIRECTOR
Mural Oncology

Study Locations (Sites)

UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Orlando Health, Inc
Orlando, Florida, 32806
United States
Norton Cancer Center
Louisville, Kentucky, 40018
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
NYU Laura and Isaac Perimutter Cancer Center
New York, New York, 10016
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
UT Southwestern Medical Center of Dallas
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Mural Oncology, Inc

  • Mural Oncology Medical Monitor, STUDY_DIRECTOR, Mural Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-27
Study Completion Date2025-05-08

Study Record Updates

Study Start Date2021-09-27
Study Completion Date2025-05-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Cutaneous Melanoma
  • Mucosal Melanoma