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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.