Study of Vemurafenib, Cobimetinib, and Atezolizumab for Patients with High-Risk, Surgically Removable BRAF Mutated and Wild-Type Melanoma

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What is this study about?

This clinical trial is focused on studying treatments for melanoma, a type of skin cancer. The study involves patients with high-risk melanoma that can be surgically removed. The trial will use a combination of three medications: vemurafenib, cobimetinib, and atezolizumab. Vemurafenib is a medication that targets a specific protein in cancer cells, cobimetinib is a selective inhibitor that blocks a pathway involved in cancer cell growth, and atezolizumab is a type of antibody that helps the immune system fight cancer.

The purpose of the study is to determine how well these treatments work in eliminating cancer cells before and after surgery. Participants will receive these medications in different sequences or combinations. Vemurafenib and cobimetinib are taken orally as tablets, while atezolizumab is given through an intravenous injection, which means it is administered directly into a vein. The study will monitor the response of the cancer to these treatments over a period of time, aiming to see if the cancer can be completely removed or reduced significantly.

Throughout the study, researchers will also observe the safety of the treatments and any changes in the cancer or the patient’s immune system. The study will track how long patients remain free from cancer recurrence and overall survival rates. This information will help in understanding the effectiveness of the treatment combinations and their impact on patients with melanoma.

1 initial treatment phase

The initial phase involves the administration of vemurafenib and cobimetinib. These medications are taken orally. The specific dosage and frequency will be determined by the medical team based on individual patient needs.

This phase is designed to prepare the body for surgery by reducing the size of the melanoma.

2 surgical intervention

Following the initial treatment phase, a surgical procedure is performed to remove the melanoma. The surgery aims to achieve complete removal of the tumor with clear margins, meaning no cancer cells are left at the edges of the removed tissue.

3 post-surgery treatment phase

After surgery, the treatment continues with the administration of atezolizumab, which is given through an intravenous injection. This phase is intended to eliminate any remaining cancer cells and reduce the risk of recurrence.

The duration and frequency of this treatment will be specified by the healthcare provider.

4 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor recovery and check for any signs of cancer recurrence. These appointments may include physical examinations, imaging tests, and blood tests.

The follow-up period is crucial for assessing the effectiveness of the treatment and ensuring the patient’s well-being.

Who Can Join the Study?

Patients must be at least 18 years old.
Women who can have children must have a negative pregnancy test at the start and use a reliable birth control method during the study and for 24 weeks after the last dose of the study drugs.
Men who are sexually active with women who can have children must use a reliable birth control method during the study and for 24 weeks after the last dose of the study drugs.
Patients must be able to give written consent, agreeing to follow the study’s rules and restrictions.
Patients must have a type of skin cancer called Stage IIIB/C/D resectable cutaneous melanoma. This means the cancer can be removed by surgery, and the decision is made by the patient’s cancer surgeon and confirmed by a team of cancer specialists. The cancer should not involve major blood vessels, nerves, or bones, and it should be possible to remove it completely with clear margins.
Patients must know their BRAF V600E/K mutation status, which is a specific genetic feature of the cancer.
Patients must be healthy enough to have surgery, as decided by the surgical team.
Patients must have cancer that can be measured, as defined by a standard called RECIST 1.1.
Patients must have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but can still do light work.
Patients must have proper organ and bone marrow function, as required by the study.
Patients should not have any psychological, family, or social issues that might prevent them from following the study plan and attending follow-up visits.

Who Cannot Join the Study?

Patients with a type of skin cancer called Melanoma that is not considered high-risk or cannot be removed by surgery.
Patients with BRAF mutations in their Melanoma that are not suitable for the study. BRAF is a gene that can affect cancer growth.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Ospedale Santa Maria Annunziata	Bagno A Ripoli	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ipsgxmxz Rrbgvebwm Pmm Lf Swttho Dzq Tagmia Djgl Acxeygl Idws Szwirf	Meldola	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	10.12.2020

Trial locations

Investigated drugs:

Vemurafenib is a medication used to treat certain types of skin cancer, specifically melanoma, that have a specific mutation known as BRAF. It works by targeting and blocking the activity of the mutated BRAF protein, which helps to slow down or stop the growth of cancer cells.

Cobimetinib is a medication that is often used in combination with other drugs to treat melanoma. It works by inhibiting a protein called MEK, which is part of a pathway that helps cancer cells grow. By blocking this protein, cobimetinib can help stop the growth of cancer cells.

Atezolizumab is an immunotherapy drug used to treat various types of cancer, including melanoma. It works by helping the immune system recognize and attack cancer cells. Atezolizumab blocks a protein called PD-L1, which is used by cancer cells to hide from the immune system, allowing the immune system to better target and destroy the cancer cells.

Investigated diseases:

Malignant melanoma

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It is characterized by the uncontrolled growth of these cells, often appearing as a new or changing mole on the skin. Melanoma can occur anywhere on the body, but it is most commonly found on areas exposed to the sun, such as the back, legs, arms, and face. The disease can progress by spreading to other parts of the body, including the lymph nodes and internal organs. Melanoma is known for its potential to grow and spread quickly, making early detection crucial. It can be classified into different types based on genetic mutations, such as BRAF mutated and wild-type, which can influence its behavior and progression.

Trial ID:

2024-516659-41-00

Protocol code:

NEO-TIM

NCT ID:

NCT04722575

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Vemurafenib, Cobimetinib, and Atezolizumab for Patients with High-Risk, Surgically Removable BRAF Mutated and Wild-Type Melanoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?