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Cytokine
Nemvaleukin Alfa for Melanoma (ARTISTRY-6 Trial)
Phase 2
Recruiting
Research Sponsored by Mural Oncology, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient must have unresectable and/or metastatic cutaneous melanoma for Cohort 1, unresectable and/or metastatic mucosal melanoma for Cohort 2, and unresectable and/or metastatic cutaneous melanoma for Cohort 3 (excluding acral melanoma for Cohort 3)
Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an estimated life expectancy of ≥3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from the first dose
Awards & highlights
ARTISTRY-6 Trial Summary
This trial is testing a new drug to treat melanoma that has not responded to other treatments.
Who is the study for?
This trial is for adults with advanced cutaneous or mucosal melanoma who've had prior anti-PD-[L]1 therapy, possibly with anti-CTLA-4 therapy, and at most one other systemic cancer treatment. They should be in good physical condition (ECOG status of 0 or 1), have a life expectancy over three months, measurable disease not recently treated by radiation or biopsy, and stable disease after previous treatments.Check my eligibility
What is being tested?
The study tests Nemvaleukin Alfa's effectiveness against advanced melanoma post anti-PD-[L]1 therapy. It explores different administration methods: subcutaneous injection, intravenous infusion, and less frequent dosing intravenously to evaluate tumor response and drug safety.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs; skin reactions at the injection site; flu-like symptoms including fever and chills; fatigue; nausea; potential changes in blood pressure and heart rate.
ARTISTRY-6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have advanced skin or mucosal melanoma that cannot be removed by surgery.
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I can care for myself and doctors expect me to live for at least 3 more months.
Select...
I've had anti-PD-1/PD-L1 therapy and at most one other cancer treatment.
Select...
My cancer responded well or remained stable with anti-PD-[L]1 therapy.
ARTISTRY-6 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from the first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from the first dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Centrally-assessed overall response rate (ORR) (Cohort 1 and 2)
Investigator-assessed overall response rate (ORR) (Cohort 3)
Secondary outcome measures
Centrally-assessed disease control rate (DCR) (Cohort 1 and 2)
Centrally-assessed duration of response (DOR) (Cohort 1 and 2)
Centrally-assessed progression free survival (PFS) (Cohort 1 and 2)
+12 moreARTISTRY-6 Trial Design
3Treatment groups
Experimental Treatment
Group I: Advanced mucosal melanoma with IV Dosing (Cohort 2)Experimental Treatment1 Intervention
Patients with unresectable and/or metastatic mucosal melanoma
Group II: Advanced Cutaneous Melanoma with Less Frequent IV Dosing (Cohort 3)Experimental Treatment1 Intervention
Patients with unresectable and/or metastatic cutaneous melanoma
Group III: Advanced Cutaneous Melanoma Subcutaneous Dosing (Cohort 1)Experimental Treatment1 Intervention
Patients with unresectable and/or metastatic cutaneous melanoma
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Who is running the clinical trial?
Mural Oncology, IncLead Sponsor
5 Previous Clinical Trials
827 Total Patients Enrolled
Alkermes, Inc.Lead Sponsor
114 Previous Clinical Trials
26,640 Total Patients Enrolled
Carlos Mayo, MDStudy DirectorMural Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have advanced skin or mucosal melanoma that cannot be removed by surgery.I have never stopped immunotherapy because of side effects.My cancer has a BRAF mutation; I may or may not have had targeted therapy.I can care for myself and doctors expect me to live for at least 3 more months.I have had a transplant of an organ, stem cells, or bone marrow that was not my own.I have a bleeding disorder that cannot be controlled.My heart's electrical cycle is longer than normal or I take medications that can extend this cycle.I've had anti-PD-1/PD-L1 therapy and at most one other cancer treatment.I need more than 10 mg of prednisone daily, not including creams, eye drops, or inhalers.My brain metastases are treated and I'm stable with low-dose steroids.I had severe side effects from previous immunotherapy and haven't fully recovered or am on steroids.My cancer can be measured and hasn't been recently treated with radiation or biopsied.I have been diagnosed with uveal or acral melanoma.I have been treated with IL-2, IL-15, or IL-12 therapies before.My cancer responded well or remained stable with anti-PD-[L]1 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Advanced Cutaneous Melanoma Subcutaneous Dosing (Cohort 1)
- Group 2: Advanced mucosal melanoma with IV Dosing (Cohort 2)
- Group 3: Advanced Cutaneous Melanoma with Less Frequent IV Dosing (Cohort 3)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left in this trial for participants?
"The data on clinicaltrials.gov validates that this research is currently open to participants. It was initially posted on May 27th 2021 and last modified on October 5th 2022."
Answered by AI
How many participants have signed up to partake in this medical experiment?
"Affirmative. According to the information shown on clinicaltrials.gov, this research study is presently gathering participants and was first published on May 27th 2021. This investigation needs 110 volunteers across 10 different medical sites in order to be completed successfully."
Answered by AI
In what locations can this trial be accessed?
"Presently, 10 different clinical trial sites are enrolling patients for this research. The facilities span Montréal, Jacksonville and La Jolla as well as other cities across the country. To reduce any travel expenses associated with joining the study, it is beneficial to select a medical centre proximate to your residence."
Answered by AI
What potential risks do patients face when taking Nemvaleukin Alfa Intravenously?
"The safety of Nemvaleukin Alfa Intravenous has been evaluated to be a 2 on our Power ranking system; this is due to its Phase 2 status, which implies some data exists pointing towards the drug's safety but no evidence in support of effectiveness."
Answered by AI
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