About
What is ARTISTRY-6?
ARTISTRY-6 is a research study for adult patients with advanced cutaneous melanoma or advanced mucosal melanoma that is inoperable or has spread.
This study is testing an investigational treatment called nemvaleukin alfa (nemvaleukin) as monotherapy (Cohorts 2 and 3) and in combination with pembrolizumab (Cohort 4). Nemvaleukin is investigational and not approved by any regulatory authority.
ARTISTRY-6 is being funded by the pharmaceutical company Mural Oncology.
Purpose
What is the purpose of this research?
The purpose of ARTISTRY-6 is to assess the safety and efficacy of investigational nemvaleukin as a treatment for advanced or metastatic (cancer that has spread) or inoperable cutaneous and mucosal melanoma.
Eligibility
A study investigator and staff will determine eligibility on an individual basis, beginning with the criteria listed here.
To be eligible, a participant must meet the following criteria:
- Is 18 years of age or older
- Has a diagnosis of advanced cutaneous melanoma or advanced mucosal melanoma that is inoperable or has spread
- Cohorts 1-3: Has received prior treatment with an anti-PD-[L]-1 therapy, with or without an anti-CTLA-4 therapy, and no more than one other prior treatment (e.g., targeted therapy or chemotherapy)
- Cohort 4: Has not received prior systemic anticancer therapy for unresectable or metastatic melanoma. Prior adjuvant and/or neoadjuvant PD-[L]1 treatments are allowed if there is at least 6 months between the last dose and date of recurrence
- Has not received similar medications in the past
- Additional criteria may apply
Treatments
Information About Treatment
This research study is enrolling participants in two treatment groups. Eligible participants will be assigned to a group based on his or her cancer type.
The medicine used in this study will be administered by an intravenous (IV, meaning through a person's veins) infusion.
Cutaneous Melanoma Group
Participants will receive a 30-minute intravenous infusion of nemvaleukin twice every 21 days
Mucosal Melanoma Group
Participants will receive a 30-minute intravenous infusion of nemvaleukin daily for 5 consecutive days