Nemvaleukin Alfa Intravenous for Melanoma

Phase-Based Estimates
1
Effectiveness
2
Safety
Alkermes Investigator Site, Daejeon, Korea, Republic of
Melanoma+3 More
Nemvaleukin Alfa Intravenous - Drug
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating whether a new drug called pembrolizumab (Keytruda) can help treat people with melanoma.

See full description

Eligible Conditions

  • Melanoma
  • Cancer of Skin
  • Cutaneous Melanoma
  • Skin Neoplasms
  • Mucosal Melanoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Nemvaleukin Alfa Intravenous will improve 1 primary outcome and 15 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Assessed up to 2 years from the first dose.

Year 2
Centrally-assessed disease control rate (DCR)
Centrally-assessed duration of response (DOR)
Centrally-assessed overall response rate (ORR)
Centrally-assessed progression free survival (PFS)
Centrally-assessed time to response (TTR)
Incidence of treatment-emergent adverse events
Investigator-assessed disease control rate (DCR)
Investigator-assessed duration of response (DOR)
Investigator-assessed immune disease control rate (iDCR)
Investigator-assessed immune duration of response (iDOR)
Investigator-assessed immune overall response rate (iORR)
Investigator-assessed immune progression free survival (iPFS)
Investigator-assessed immune time to response (iTTR)
Investigator-assessed overall response rate (ORR)
Investigator-assessed time to response (TTR)
Year 2
Investigator-assessed progression free survival (PFS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Advanced mucosal melanoma

This trial requires 110 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nemvaleukin Alfa Intravenous is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Advanced mucosal melanoma
Drug
Patients with unresectable and/or metastatic mucosal melanoma
Advanced Cutaneous Melanoma
Drug
Patients with unresectable and/or metastatic cutaneous melanoma

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years from the first dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years from the first dose for reporting.

Closest Location

Alkermes Investigator Site - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have a disease that can be measured using RECIST 1.1., that has not recently been irradiated or used to collect a biopsy. show original
The patient is willing to have a pretreatment tumor biopsy or to provide qualifying archival tumor tissue. show original
The patient is in good health and has an estimated life expectancy of three or more months. show original
The following text may have other criteria which applies. show original
A patient's best overall response (BOR) to anti-PD-[L]1 therapy can be an objective response (partial response [PR] or CR; by RECIST 1.1 or iRECIST) or stable disease (SD; by RECIST 1.1 or iRECIST) show original
Some patients with BRAF mutations have received prior targeted therapy while others have not. show original
Advanced cutaneous or acral melanoma, with no more than 5 patients with acral melanoma, is required for enrollment in Cohort 1 show original
The patient has been treated with anti-PD-[L]1 therapy with or without anti-CTLA-4 therapy, and no more than one other prior treatment regime of systemic anti-neoplastic therapy (eg, targeted therapy, chemotherapy) show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is melanoma?

Add answer

The most common type of cancer in western Caucasian populations—melanoma, affects between 20 and 50,000 people and is usually sporadic, occurring spontaneously in those without previous pigmented skin lesions. Most people with melanoma live to be older than 95 years of age.\n

Unverified Answer

Can melanoma be cured?

Add answer

Can this disease be cured? A precise classification of the patient into subgroups with a defined prognosis should be performed. The detection of melanoma in its early stages is most important to prevent distant metastasis and morbidity.

Unverified Answer

What are common treatments for melanoma?

Add answer

More than 95% of melanomas were in situ at the time of excision. Treatment options for melanomas include surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, and biotherapy. Other treatments included cryosurgery (cryoablation) when melanoma was primary to a lymph node, metastatic, or other site, and photodynamic therapy used at the local site of the cancer. In rarer cases the cancer may cause obstruction of a major airway, so treatment may include lung-resection surgery, embolization of abnormal blood vessels, or treatment with palliative irradiation. The American College of Surgeons recommends lymph node dissection for most stages of cutaneous melanoma.

Unverified Answer

How many people get melanoma a year in the United States?

Add answer

About 20,000 new melanomas occur in the United States each year. About 75% are the result of sun exposure from outdoor activities. Most cases occur in people aged 40 to 59 years (55%). Most cases show the same trends as those reported in other countries: they mostly originate from fair skinned persons and are less common in Caucasians. In this country, about 10% of cases are attributed to indoor exposure.

Unverified Answer

What are the signs of melanoma?

Add answer

The signs of melanoma are not unique to melanoma but common amongst all [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer)s. The signs and symptoms of melanoma vary greatly, depending upon the type of cancer and the stage at diagnosis. The symptoms and signs of melanoma may start many months, even years, before the cancer is detected.

Unverified Answer

What causes melanoma?

Add answer

It is not clear whether UV radiation is the sole cause of melanoma, it being a major risk factor. More importantly it is not clear if certain types of melanoma are associated with UV radiation. The two most serious types, uveal and nodular, are not associated with UV radiation, raising suspicion that melanoma can have other causes.

Unverified Answer

How serious can melanoma be?

Add answer

Based on current observations, we are confident that people with melanoma are still in danger. It's time to take proactive precautionary measures. We need better awareness of melanoma. We also need better prevention of acquiring a melanoma.

Unverified Answer

How quickly does melanoma spread?

Add answer

The key principle for managing any cancer patient is to find and treat any potentially premalignant or malignant lesions as soon as possible. The more the clinician is proactive in this work-up, the earlier the patient can be spared life-threatening treatment.

Unverified Answer

Who should consider clinical trials for melanoma?

Add answer

A sizeable number of patients can be spared the discomfort and side effects of such testing, and they might be at high risk in the first place.

Unverified Answer

Does melanoma run in families?

Add answer

Significant linkage of risk for developing melanoma is found on chromosomes 2q, 6p and 8q, supporting genetic risk factors in determining susceptibility for the disease. It is important to consider genetic risk factors for melanoma and preventive strategies for the disease. The risk can be reduced for future generations, thus prevention and early diagnosis can help a patient to live a normal life and achieve a favorable outcome. The risk is higher for those who have one first degree relative, with an odds ratio being 6.75 (95% CI: [3.13, 15.31]) when comparing subjects with a first degree relative with respect to subjects without a first degree relative, suggesting there is a genetic risk factor for developing melanoma.

Unverified Answer

What does nemvaleukin alfa intravenous usually treat?

Add answer

The medication is given in a manner similar to its use in leukocyte reduction. It usually results in no significant changes in most measurements, though the most significant changes included slight increases in triglyceride levels, elevated blood potassium levels, and moderately increased blood glucose levels. There were no clinically significant changes in kidney function test results. There were no clinically significant changes in hematologic parameters. There was no significant change in blood pressure, heart arrhythmia, or abnormal heart rhythm parameters, though there was clinically apparent tachycardia. There were also no clinically apparent adverse effects on the overall quality of life of the patients.

Unverified Answer

What are the common side effects of nemvaleukin alfa intravenous?

Add answer

Side effects of nemvalukin alfa are common, with fatigue, anemia, nausea, vomiting, headache, pain, fever, infusion site reactions, and diarrhea frequently reported, among other adverse events as grade 2-3. Tumour necrosis (tumour regression) ≥10% have not been reported in any clinical trial with nemvalukin alfa in patients with advanced melanoma.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Melanoma by sharing your contact details with the study coordinator.