This clinical trial is focused on studying a type of skin cancer known as Advanced Melanoma. The study will explore the effects of two treatments: EIK1001 and Pembrolizumab. Pembrolizumab is a medication that helps the immune system fight cancer cells, while EIK1001 is a new treatment being tested. The trial will compare the combination of EIK1001 and Pembrolizumab against a combination of a placebo and Pembrolizumab to see which is more effective as a first-line therapy, meaning it is the first treatment given for this condition.
The purpose of the study is to evaluate the safety and effectiveness of EIK1001 when used with Pembrolizumab. Participants will receive these treatments through an intravenous method, which means the medication is given directly into a vein. The study will last for up to 24 months, during which time participants will be monitored closely to assess how well the treatment works and to check for any side effects. The study aims to determine if the combination of EIK1001 and Pembrolizumab can help patients live longer without the cancer getting worse, and if it can improve overall survival compared to the placebo and Pembrolizumab combination.
Throughout the study, participants will undergo regular check-ups and tests to track their progress. These tests may include imaging scans like MRI or CT scans, which help doctors see how the cancer is responding to the treatment. The study is designed to ensure that all participants receive the best possible care while contributing to important research that could improve treatment options for people with advanced melanoma in the future.
1joining the study
Upon joining the study, the participant will be randomly assigned to one of the treatment groups. This process is double-blind, meaning neither the participant nor the researchers will know which group the participant is in.
2treatment administration
Participants will receive either pembrolizumab or a combination of pembrolizumab and EIK1001. Both medications are administered intravenously, which means they are given through a vein.
Pembrolizumab is a medication used to treat advanced melanoma. The dosage and frequency will be determined by the study protocol.
EIK1001 is provided as a solution for injection with a concentration of 1.0 mg/mL. The specific dosage and frequency will be adjusted during the study to find the most effective dose.
3monitoring and assessments
Throughout the study, participants will undergo regular assessments to monitor their health and the effectiveness of the treatment. This includes imaging tests like CT or MRI scans to measure the size of the melanoma.
Participants will also have regular blood tests to check organ function and overall health.
4evaluation of treatment response
The study aims to evaluate the response to the treatment using criteria known as RECIST 1.1. This involves determining whether the melanoma has shrunk, remained stable, or grown.
The primary goals are to assess progression-free survival, which is the time during and after treatment that the participant lives with the disease without it getting worse, and overall survival, which is the time from the start of treatment until death from any cause.
5completion of the study
The study is expected to continue until May 2030. Participants will be followed up for a period after the last dose of the study medication to monitor long-term effects and outcomes.
Who Can Join the Study?
Must be at least 18 years old on the day of signing the consent form.
Must be willing to use two reliable methods of birth control, one reliable method plus a hormonal method, or agree to avoid heterosexual activity during the study. This applies to women who can have children and are not menopausal for more than 2 years, have not had their uterus or ovaries removed, or are not surgically sterilized.
Male participants with a female partner who can have children must agree to use an approved method of birth control during the study.
Must be willing and able to provide written consent to participate in the study.
Must have a life expectancy of at least 3 months.
Must have a confirmed diagnosis of Stage 3 (unresectable) or Stage 4 metastatic melanoma according to the American Joint Committee on Cancer (AJCC) 8th edition and be eligible for standard treatment with pembrolizumab.
Must have at least one tumor that can be measured at the start of the study using a CT or MRI scan, according to specific criteria used to evaluate solid tumors.
Must know their BRAF V600 mutation status or agree to be tested for it during the screening period, following local standards.
Must have completed any previous radiation therapy at least 2 weeks before starting the study treatment.
Must have an ECOG Performance Status of 0 to 1, which is a scale used to assess how well a person can perform daily activities.
Must have normal organ and bone marrow function, as shown by blood tests done within 10 days before starting treatment.
Women who can have children must have a negative pregnancy test within 72 hours before receiving the first dose of the study medication.
Who Cannot Join the Study?
Patients who have a different type of cancer other than advanced melanoma cannot participate. Advanced melanoma is a serious form of skin cancer that has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.
EIK1001 is an investigational medication being studied for its potential to treat advanced melanoma. It is being tested in combination with another medication to see if it can improve outcomes for patients with this type of cancer. The study aims to determine if EIK1001 can help slow down the progression of the disease and improve survival rates when used alongside another treatment.
Pembrolizumab is a medication already used in the treatment of advanced melanoma. It works by helping the immune system recognize and attack cancer cells. In this clinical trial, pembrolizumab is being used as a standard treatment to compare the effects of adding EIK1001 to the therapy regimen. The goal is to see if the combination of pembrolizumab and EIK1001 is more effective than pembrolizumab alone.
Advanced Melanoma – Advanced melanoma is a type of skin cancer that has spread beyond the original site to other parts of the body. It begins in the melanocytes, which are the cells responsible for producing the pigment melanin that colors the skin. As the disease progresses, it can invade nearby tissues and organs, making it more challenging to treat. Symptoms may include changes in existing moles, the appearance of new pigmented or unusual-looking growths on the skin, and, in some cases, swelling of lymph nodes. The progression of advanced melanoma can vary, with some cases spreading rapidly while others may grow more slowly. It is important to monitor any changes in the skin and consult a healthcare professional for evaluation.
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