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Study of Regorafenib with BRAF/MEK-Inhibitor Combination for Patients with Advanced Melanoma After Previous Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called regorafenib on patients with advanced melanoma, a type of skin cancer. The study is specifically for patients who have already received treatment for their melanoma but need additional options. Regorafenib, also known by its code name BAY73-4506, is provided in the form of film-coated tablets and is taken orally, meaning it is swallowed. The purpose of the study is to evaluate how well regorafenib works when added to a combination of other treatments known as BRAF and MEK inhibitors, which are used to target specific mutations in melanoma cells.

Participants in the study will receive regorafenib in addition to their existing treatment regimen. The study will observe how the cancer responds to this combination, looking for any reduction in tumor size or slowing of disease progression. The trial will also monitor the overall health and safety of participants, checking for any side effects or changes in their condition. The study aims to provide more information on the potential benefits of regorafenib for patients with melanoma who have specific genetic mutations, such as the BRAF V600 mutation.

The trial will last for a period of time, during which participants will be regularly assessed to track their response to the treatment. This includes medical examinations and tests to ensure the safety and effectiveness of the medication. The study hopes to offer new insights into treatment options for advanced melanoma, potentially improving outcomes for patients with this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, ability to take oral medication, and previous treatment history.
A signed informed consent is required to participate in the trial.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status. This includes a physical examination, blood and urine tests, and imaging studies to identify measurable lesions.
Step 3
Treatment initiation
The treatment involves taking Stivarga (regorafenib) 40 mg film-coated tablets orally.
The medication is administered once daily for three weeks, followed by a one-week break, completing a four-week cycle.
Step 4
Ongoing monitoring
Regular monitoring is conducted to assess the response to treatment and any side effects. This includes clinical examinations, blood and urine tests, and imaging studies.
The health status is evaluated using questionnaires to assess quality of life and specific health-related concerns.
Step 5
Response evaluation
The response to treatment is evaluated using criteria to determine if there is a complete or partial response, stable disease, or progression.
The duration of response and progression-free survival are measured to assess the effectiveness of the treatment.
Step 6
Completion of trial
The trial is estimated to end by December 31, 2025. Participation continues until the end of the trial or until the treatment is no longer beneficial.
Final assessments are conducted to evaluate overall survival and any long-term effects of the treatment.

Who can join the trial?

14 criteria

Must be at least 18 years old.
Must be able to swallow pills and not have any serious stomach or bowel problems that affect how the body absorbs medicine.
Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 16 weeks after the last dose.
Men with a female partner who can have children must have had a vasectomy or agree to use effective birth control starting 14 days before the first dose, during the study, and for 16 weeks after the last dose.
Must have a performance status of 0, 1, or 2, which means being able to carry out daily activities with varying levels of assistance.
Must have adequate organ function, which includes specific levels of blood cells, liver, and kidney function.
Can have a certain level of protein in the urine, but it must be below a specific amount.
Must sign a written informed consent form, agreeing to participate in the study.
Must have advanced melanoma, which is a type of skin cancer that has spread and cannot be removed by surgery.
Must have tried and not responded to previous treatments with certain immune therapies and, if applicable, treatments targeting a specific gene mutation called BRAF V600.
For certain groups, must be currently on or have recently stopped treatment with BRAF-MEK inhibitors.
Must have at least one measurable tumor according to specific criteria.
Must have a certain amount of time between the last cancer treatment and starting the study treatment, depending on the type of previous treatment.
Any side effects from previous cancer treatments must be mild or resolved, except for hair loss and certain lab test results.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with melanoma, which is a type of skin cancer.
Patients who have not been treated with a combination of BRAF and MEK inhibitors. These are specific types of medications used to treat certain cancers.
Patients who have not experienced progression, meaning their cancer has not worsened, while on BRAF-MEK inhibitor therapy.
Patients who have not stopped BRAF-MEK inhibitor therapy for at least 12 weeks.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

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Vrije Universiteit Brussel
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Jette, Belgium

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Investigated drugs

Regorafenib
is a medication used in this trial to assess its ability to fight tumors in patients with advanced melanoma. It is being tested in combination with other treatments to see if it can help control the disease in patients who have already been treated with other therapies.
BRAF Inhibitor
is a type of medication that targets and blocks the activity of a specific protein known as BRAF, which is involved in the growth of cancer cells. This trial includes patients who have previously been treated with a BRAF inhibitor.
MEK Inhibitor
is another type of medication used in this trial. It works by blocking the MEK proteins, which are part of a pathway that helps cancer cells grow. The trial involves patients who have been treated with a MEK inhibitor before.

Regorafenib

What is already known about the treatment

Regorafenib – Regorafenib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating advanced melanoma, particularly in patients who have previously been treated with other therapies. The main therapeutic indication for regorafenib in this context is advanced melanoma with a specific genetic mutation known as BRAF V600. At the molecular level, regorafenib works by inhibiting multiple protein kinases, which are involved in tumor growth and progression. It is classified pharmacologically as a multikinase inhibitor.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new mole or a change in an existing mole, typically with irregular borders and multiple colors. The disease can progress by spreading to other parts of the body, including the lymph nodes and internal organs. Melanoma is more likely to spread than other types of skin cancer, making early detection crucial. It can occur on any skin surface but is most common on areas exposed to the sun, such as the back, legs, arms, and face. The progression of melanoma is categorized by stages, which indicate the extent of spread and depth of the tumor.