Study on Melanoma Treatment: Comparing Encorafenib and Binimetinib with Ipilimumab and Nivolumab for Patients with BRAF V600 Mutation

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What is this study about?

This clinical trial is focused on studying treatments for BRAF V600 mutation-positive unresectable or metastatic melanoma, a type of skin cancer that cannot be removed by surgery or has spread to other parts of the body. The study involves two different treatment approaches. One approach uses a combination of targeted therapy drugs, encorafenib and binimetinib, followed by a combination of immunotherapy drugs, ipilimumab and nivolumab. The other approach uses the immunotherapy combination of ipilimumab and nivolumab from the start.

The purpose of the study is to determine if starting with the targeted therapy drugs before moving to immunotherapy can improve the time patients live without the disease getting worse, compared to starting with immunotherapy alone. Participants in the study will receive either the targeted therapy drugs for 12 weeks followed by immunotherapy or the immunotherapy drugs alone. The targeted therapy drugs, encorafenib and binimetinib, are taken orally as capsules and tablets, while the immunotherapy drugs, ipilimumab and nivolumab, are given through intravenous injections, which means they are administered directly into a vein.

The study will monitor participants over a period of time to assess the effectiveness of these treatments in managing the disease. The main focus will be on how long patients can live without the disease progressing, as well as overall survival and response to the treatment. This trial aims to provide valuable information on the best treatment approach for patients with this specific type of melanoma.

1 Initial Treatment Phase

The initial phase involves the administration of targeted therapy for a duration of 12 weeks. This includes taking encorafenib and binimetinib.

Encorafenib is provided in the form of 75 mg hard capsules, taken orally. Binimetinib is provided as 15 mg film-coated tablets, also taken orally.

This phase is designed to prepare the body for the subsequent immunotherapy treatment.

2 Immunotherapy Phase

Following the initial treatment phase, the immunotherapy phase begins. This involves the administration of nivolumab and ipilimumab.

Nivolumab is administered as a 10 mg/mL solution for infusion, given intravenously. Ipilimumab is administered as a 5 mg/mL solution for infusion, also given intravenously.

The purpose of this phase is to enhance the immune system’s ability to fight the melanoma.

3 Monitoring and Follow-up

Throughout the trial, regular monitoring is conducted to assess the response to treatment and to ensure safety.

Progression-free survival (PFS) is evaluated, which measures the time during and after treatment that the patient lives with the disease without it getting worse.

Overall survival (OS) is also assessed, which measures the time from the start of the trial to the time of death from any cause.

Who Can Join the Study?

The patient must have a type of skin cancer called BRAF V600 mutation-positive unresectable or metastatic melanoma.
The cancer must be confirmed by a test called histology or cytology, and it should be at stage III or IV, meaning it cannot be removed by surgery.
The patient must have a BRAF V600E or V600K mutation in their tumor, confirmed by a local test.
The patient must be at least 18 years old.
The patient must have a measurable disease as determined by specific imaging tests like CT or MRI scans.
The patient must have a good performance status, which means they are able to carry out daily activities with little or no assistance.
The patient must have adequate organ function, which includes specific blood counts and liver and kidney function tests within normal ranges.
The patient must have adequate heart function, including a specific heart test called an echocardiogram or MUGA scan.
Women who can become pregnant must have a negative pregnancy test before joining the study and must use effective birth control during the study and for a period after the study ends.
Men must also use effective birth control during the study and for a period after the study ends.
Female patients must not be breastfeeding during the study and for a period after the study ends.
The patient must be willing and able to follow the study rules, including attending scheduled visits and undergoing tests and treatments.
The patient must provide written informed consent, which means they agree to participate in the study after being informed about it.
The patient must be able to swallow and retain oral tablets.
The patient must provide a sample of their tumor tissue for analysis, which can be an archived sample if it was taken within 3 months before joining the study and no treatment was given since then.
Patients with thyroid problems that are stable with treatment can participate.

Who Cannot Join the Study?

Patients who do not have a BRAF V600 mutation in their melanoma. This is a specific change in the cancer cells that the study is focusing on.
Patients whose melanoma can be surgically removed. The study is for those whose cancer cannot be taken out with surgery.
Patients who do not have metastatic melanoma. This means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
Patients who are participating in another clinical trial at the same time.
Patients who have had certain treatments for their melanoma before, which might affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Centre Jean Perrin	Clermont Ferrand	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Netherlands Cancer Institute	Amsterdam	The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Pau	Pau	France
Csrjar Lhtt Btossb	Lyon	France
Aujtzktzjq Pezafpyv Hogdqise Dr Mrusxdjoj	Marseille	France
Bfqriesw Uckpmgherr Hioczqpz Cqobes	Besançon	France
Apntknp Ohkberztrqp Uaxcktqeicocc Ssooqp	Siena	Italy
Ccsmhj Hpisonvybad Ruwxgrbe Uddgvwkvxqkgp Dz Ttcwz	Tours	France
Acuitdq Opqusigtgbr Upoehrfntlqlm Czpoqiezopxd Dnmfs Sxdiyh E Dfokm Sastvqj Dv Tjdbvz	Turin	Italy
Nabrazmw Irtcvplm Oqxdaaxyb Ivj Mbvzv Stytqiymyfutqdutbwryxrknzgyb Iswbqsmj Bbhrowjw	Cracow	Poland
Uyyozrieqamvxmjoufzhp Wwvjxiucv Ang	Wuerzburg	Germany
Aaowcye Ovanrysgsbq Poqg Gwvskyit Xgkik	Bergamo	Italy
Ipwfrq Iyudayik Fndirkerrqffr Oipututcxzj	Rome	Italy
Igzuetfh Ceauda Dyjkdhcmufilkillj	L'hospitalet De Llobregat	Spain
Iooytvjj dz Cufdfylqjota Hayjbhzbvkc Uxruhuvekjoio dm Skfgu Eamaxoj (njwbngw	Saint Priest En Jarez	France
Hnxecxri Vqjd dtrbtiyr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	12.11.2018
Germany	Not recruiting	12.11.2018
Italy	Not recruiting	12.11.2018
Poland	Not recruiting	12.11.2018
Spain	Not recruiting	12.11.2018
The Netherlands	Not recruiting	12.11.2018

Trial locations

Investigated drugs:

Encorafenib is a medication used in this trial to target specific cancer cells in patients with melanoma that have a BRAF V600 mutation. It works by blocking certain proteins that promote the growth of cancer cells, helping to slow down or stop the progression of the disease.

Binimetinib is another targeted therapy used alongside encorafenib. It helps to inhibit the growth of cancer cells by interfering with specific pathways that are involved in cell division and survival, particularly in melanoma with the BRAF V600 mutation.

Ipilimumab is an immunotherapy drug used in this trial to help the immune system recognize and attack cancer cells. It works by blocking a protein that normally keeps the immune system in check, allowing the immune cells to better target and destroy cancer cells.

Nivolumab is also an immunotherapy medication used in combination with ipilimumab. It enhances the body’s immune response against cancer cells by blocking a different protein that can prevent immune cells from attacking tumors. This helps to improve the body’s ability to fight 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 be aggressive and has the potential to spread to other parts of the body, including the lymph nodes and internal organs. The disease is more common in individuals with fair skin and those with a history of excessive sun exposure. In cases where melanoma is unresectable or metastatic, it means the cancer cannot be surgically removed or has spread beyond its original site. The presence of a BRAF V600 mutation in melanoma can influence the behavior of the cancer and its response to certain treatments.

Trial ID:

2023-505376-30-00

Protocol code:

EORTC 1612-MG

NCT ID:

NCT03235245

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Melanoma Treatment: Comparing Encorafenib and Binimetinib with Ipilimumab and Nivolumab for Patients with BRAF V600 Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?