Not recruiting

Study on the Effectiveness of Pembrolizumab and Lenvatinib for Patients with Resectable Mucosal Melanoma

Verified siteRegistered drugNo placebo

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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 a type of skin cancer known as mucosal melanoma, which can be surgically removed. The study is investigating the effectiveness of a treatment plan that includes a combination of medications and therapies. The medications being used in this study are Lenvima (lenvatinib) and Keytruda (pembrolizumab). Lenvima is taken as a capsule, while Keytruda is given as an infusion through a vein. The purpose of the study is to evaluate how well these treatments work in preventing the return of cancer after surgery.

Participants in the study will first receive a treatment called neo-adjuvant therapy, which is given before surgery to help shrink the tumor. This therapy may include the use of Keytruda alone or in combination with Lenvima. After the surgery, patients may receive radiotherapy, which uses high-energy rays to kill any remaining cancer cells. Following these treatments, patients will continue with maintenance immunotherapy, which helps the immune system fight cancer cells and aims to keep the cancer from coming back.

The study will monitor patients over a period of time to assess their disease-free survival, which means the length of time they remain free from cancer after treatment. The goal is to compare the results of this new treatment approach with past results from patients who only received surgery and radiotherapy. This study hopes to provide valuable information on improving treatment outcomes for patients with resectable mucosal melanoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The initial treatment phase involves the administration of two medications: lenvatinib and pembrolizumab.
Lenvatinib is taken orally in the form of 10 mg hard capsules. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.
Pembrolizumab is administered intravenously as a 25 mg/mL solution for infusion. The healthcare provider will determine the exact dosage and schedule.
Step 2
Surgical intervention
Following the initial treatment phase, patients undergo surgery to remove the mucosal melanoma.
The timing of the surgery will be determined by the healthcare team based on the patient's response to the initial treatment.
Step 3
Radiotherapy
If indicated, radiotherapy may be administered after surgery to target any remaining cancer cells.
The healthcare provider will discuss the need for radiotherapy and the specific schedule with the patient.
Step 4
Maintenance therapy
After surgery and any necessary radiotherapy, maintenance therapy with pembrolizumab is initiated.
This phase aims to prevent the recurrence of cancer and is part of the long-term treatment plan.
Step 5
Follow-up and monitoring
Regular follow-up appointments are scheduled to monitor the patient's health and response to treatment.
These appointments may include physical exams, imaging tests, and laboratory tests to assess disease-free survival and overall health.

Who can join the trial?

14 criteria

Be willing and able to provide written informed consent or agreement to participate in the trial.
Be over 18 years of age on the day of signing the informed consent.
Have a resectable mucosal melanoma, which means a type of skin cancer that can be surgically removed.
Be eligible for surgical treatment, meaning there are no medical reasons preventing surgery.
Be eligible for adjuvant radiotherapy, which is additional treatment given after the primary treatment to lower the risk of the cancer coming back.
Have a measurable disease based on RECIST 1.1, a set of guidelines used to measure cancer response to treatment.
Be willing to provide a tissue sample from a newly obtained biopsy of a tumor lesion, which is a small piece of tissue taken from the tumor for testing. If a new sample cannot be provided, an older sample may be used with the sponsor's agreement.
Have a performance status of 0 or 1 on the ECOG Performance Scale, which measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.
Demonstrate adequate organ function, meaning the organs are working well enough, as defined in the study's guidelines. All necessary lab tests should be done within 10 days before starting treatment.
Female participants who can have children should have a negative pregnancy test within 72 hours before receiving the first dose of study medication. If the urine test is positive or unclear, a blood test will be needed.
Female participants who can have children should agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for 120 days after the last dose of study medication. This applies to those who have not been surgically sterilized or have not stopped having periods for more than a year.
Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy and continuing for 120 days after the last dose.
Be affiliated with a social security system or be a beneficiary of one.
Not have any contraindication for lenvatinib treatment, meaning there are no medical reasons preventing the use of this medication.

Who cannot join the trial?

10 criteria

Patients who have a type of cancer called mucosal melanoma that cannot be removed by surgery.
Patients who have other serious health conditions that might interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
Patients who are currently participating in another clinical trial.
Patients who have an active infection that requires treatment.
Patients who have a known allergy to the study drugs.
Patients who have received certain treatments for their cancer recently, such as chemotherapy or radiation.
Patients who have a history of certain heart problems.
Patients who have a condition that affects their immune system.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHU Croix Rousse-Lyon
Verified
Lyon, France
Centre Hospitalier Intercommunal Creteil
Verified
Creteil, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France

Trial locations

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Investigated drugs

Anti-PD1 Immunotherapy
is a type of treatment that helps the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1, which can stop the immune system from attacking cancer cells. In this trial, it is used both before surgery to shrink the tumor and after surgery to help prevent the cancer from coming back.
Lenvatinib
is a medication that helps stop the growth of cancer cells by blocking certain proteins that cancer cells need to grow. In this trial, it is used in combination with anti-PD1 immunotherapy before surgery to enhance the treatment's effectiveness in shrinking the tumor.

What is already known about the treatment

Anti-PD1 Immunotherapy
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating resectable mucosal melanomas. It is an established form of immunotherapy in medical literature, primarily used for various types of cancer. The main therapeutic indication is to improve disease-free survival in patients with resectable mucosal melanomas. At the molecular level, it works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.
Lenvatinib
This medication is taken orally and is being evaluated in combination with anti-PD1 immunotherapy for its potential benefits in treating resectable mucosal melanomas. It is recognized in medical literature as a treatment for certain types of cancer. The primary therapeutic indication is to enhance the effectiveness of immunotherapy in improving disease-free survival. Lenvatinib works by inhibiting multiple receptor tyrosine kinases involved in tumor growth and angiogenesis. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Resectable Mucosal Melanomas – This is a type of melanoma that occurs on the mucous membranes of the body, such as those in the mouth, nose, or other internal surfaces. Unlike cutaneous melanoma, which appears on the skin, mucosal melanomas are less common and can be more challenging to detect early. The disease progresses as the cancer cells grow and potentially spread to nearby tissues or other parts of the body. It is considered resectable when the tumor can be surgically removed. The progression of the disease can vary, with some cases remaining localized while others may spread to lymph nodes or distant organs. Early detection and surgical intervention are crucial in managing the disease's progression.