Nemvaleukin Alfa for Melanoma
(ARTISTRY-6 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Nemvaleukin Alfa for individuals with advanced melanoma that cannot be surgically removed or has metastasized. The trial aims to evaluate the treatment's effectiveness against cancer, its safety, and how the body processes it. Participants are grouped based on melanoma type (skin or mucosal) and previous treatments. Eligible participants must have certain types of melanoma, possibly have undergone previous cancer treatments, and still have measurable disease. They should also not have received specific prior therapies. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids (more than 10 mg of prednisone daily or equivalent), you may need to adjust your dosage. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Nemvaleukin Alfa, used alone or with pembrolizumab, has been generally safe in previous studies. Side effects were usually mild and manageable. In studies involving melanoma patients, even those with extensive prior treatments, Nemvaleukin Alfa was well-tolerated. This treatment has been tested in both skin-related and moist tissue-related melanoma, demonstrating a good safety record. Evidence so far suggests that Nemvaleukin Alfa is relatively safe for these patients, making it a potential option for those considering clinical trials.12345
Why are researchers excited about this trial's treatment for melanoma?
Unlike the standard treatments for melanoma, which often include drugs like nivolumab or ipilimumab, Nemvaleukin Alfa targets a different pathway. It works by selectively activating immune cells to attack the cancer, potentially improving the immune response against melanoma. Researchers are excited because it can be administered in both intravenous and subcutaneous forms, offering flexibility and convenience in dosing. This approach could enhance treatment effectiveness and reduce side effects compared to current therapies.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research has shown that Nemvaleukin Alfa may help treat advanced melanoma, a serious type of skin cancer. In this trial, some participants will receive Nemvaleukin Alfa alone, while others will receive it with pembrolizumab, an immunotherapy that aids the immune system in fighting cancer. One study found that 13% of patients responded well to the treatment, with some even experiencing complete tumor disappearance. The treatment appears safe and manageable, even for patients who have tried many other treatments. These findings suggest that Nemvaleukin Alfa could be a valuable option for those with difficult-to-treat melanoma.24678
Who Is on the Research Team?
Mural Oncology Medical Monitor
Principal Investigator
Mural Oncology
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nemvaleukin Alfa monotherapy or in combination with Pembrolizumab for advanced melanoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nemvaleukin Alfa
Trial Overview
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.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Patients with unresectable and/or metastatic mucosal melanoma
Patients with unresectable and/or metastatic cutaneous melanoma. Patients must not have 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.
Patients with unresectable and/or metastatic cutaneous melanoma
Patients with unresectable and/or metastatic cutaneous melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mural Oncology, Inc
Lead Sponsor
Alkermes, Inc.
Lead Sponsor
Richard Pops
Alkermes, Inc.
Chief Executive Officer since 1991
BA in Economics from Stanford University
Dr. Craig Hopkinson
Alkermes, Inc.
Chief Medical Officer since 2017
MD
Published Research Related to This Trial
Citations
Study Details | NCT04830124 | Nemvaleukin Alfa ...
Advanced Cutaneous Melanoma with Less Frequent IV Nemvaleukin Dosing + Pembrolizumab (Cohort 4). Patients with unresectable and/or metastatic cutaneous melanoma ...
results from the phase 1/2 non-randomized ARTISTRY-1 trial
Nemvaleukin alfa (nemvaleukin, ALKS 4230) demonstrated manageable safety and antitumor activity, alone and in combination with pembrolizumab, ...
Nemvaleukin alfa monotherapy in patients with advanced ...
We report in-depth antitumor activity, safety, pharmacokinetics, and pharmacodynamics of nemvaleukin monotherapy at the recommended phase 2 dose ...
Study Details | NCT04592653 | Less Frequent IV Dosing & ...
Patients must have histologically or cytologically confirmed diagnosis of an advanced solid tumor type of cutaneous melanoma, RCC, TNBC, MSS colorectal cancer, ...
5.
cancernetwork.com
cancernetwork.com/view/nemvaleukin-alfa-shows-promising-activity-in-advanced-solid-tumorsNemvaleukin Alfa Shows Promising Activity in Advanced ...
Per efficacy, there were 19 confirmed overall responses (13%; 95% CI, 8%-20%) among 144 patients. Of them, 5 (4%) were complete responses, and ...
Study Details | NCT04830124 | Nemvaleukin Alfa ...
This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma.
Nemvaleukin Alfa - Drug Targets, Indications, Patents
Nemvaleukin alfa (nemvaleukin, ALKS 4230) demonstrated manageable safety and antitumor activity, alone and in combination with pembrolizumab, ...
Nemvaleukin Shows Durable Antitumor Activity in ...
Nemvaleukin alfa shows promising antitumor activity in advanced melanoma and renal cell carcinoma, with manageable safety in heavily pretreated ...
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