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

Study 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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

- The patient must have received previous treatment as follows: 1.

Patient has received anti-PD-[L]1 therapy with or without anti-CTLA-4 therapy, and no more than one other prior regimen of systemic anti-neoplastic therapy (eg, targeted therapy, chemotherapy). Previous adjuvant and/or neoadjuvant therapy counts as one prior regimen. 2. 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). 3. 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 (all cohorts) or acral melanoma (Cohort 2 and Cohort 3).

- 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 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 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.

- Additional criteria may apply.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04830124
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mural Oncology, Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Carlos Mayo, MD
Principal Investigator Affiliation	Mural Oncology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, Italy, Korea, Republic of, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Melanoma, Mucosal Melanoma

Arms & Interventions

Arms

Experimental: Advanced Cutaneous Melanoma Subcutaneous Dosing (Cohort 1)

Patients with unresectable and/or metastatic cutaneous melanoma

Experimental: Advanced mucosal melanoma with IV Dosing (Cohort 2)

Patients with unresectable and/or metastatic mucosal melanoma

Experimental: Advanced Cutaneous Melanoma with Less Frequent IV Dosing (Cohort 3)

Patients with unresectable and/or metastatic cutaneous melanoma

Interventions

Drug: - Nemvaleukin Alfa Subcutaneous

Subcutaneous injection of nemvaleukin every 7 days

Drug: - Nemvaleukin Alfa Intravenous

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

Drug: - Nemvaleukin Alfa Intravenous Less Frequent Dosing

Intravenous (IV) infusion over 30 minutes once every 21 days or twice every 21 days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mural Oncology Investigator Site, La Jolla, California

Status

Recruiting

Address

Mural Oncology Investigator Site

La Jolla, California, 92093

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