Study on the Safety and Effectiveness of Pembrolizumab, Lenvatinib, and Quavonlimab for Patients with Advanced Melanoma with Brain Metastases

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What is this study about?

This clinical trial is focused on studying treatments for advanced melanoma, a type of skin cancer that has spread to the brain. The study is exploring the safety and effectiveness of different treatment combinations, including the use of pembrolizumab (also known by its code name MK-3475), which is a medication given through an intravenous infusion. Other treatments being tested include lenvatinib, taken as a capsule, and a combination of pembrolizumab and quavonlimab (known as MK-1308A), also given by infusion.

The purpose of the study is to assess how safe these treatments are and how well they work in treating melanoma that has spread to the brain. Participants will receive one or more of these treatments, or a placebo, and their health will be monitored closely throughout the study. The study will look at how the cancer responds to the treatments, including any changes in the size of the tumors, and will also track any side effects experienced by participants.

Participants in the study will undergo regular check-ups and imaging tests, such as MRI scans, to evaluate the progress of the treatment. The study aims to provide valuable information on the potential benefits and risks of these treatment combinations for people with advanced melanoma, particularly those whose cancer has spread to the brain.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking your medical history, current health status, and ensuring you meet the study’s inclusion criteria, such as having advanced melanoma with brain metastases.

3 treatment phase

During the treatment phase, you will receive the study medications. These include pembrolizumab administered as an intravenous infusion and lenvatinib taken orally as capsules. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

If you are assigned to receive pembrolizumab alone, it will be given as an intravenous infusion. If you are assigned to receive a combination treatment, you may also receive quavonlimab with pembrolizumab as an infusion.

4 monitoring and follow-up

Throughout the study, regular monitoring will occur to assess your response to the treatment and any side effects. This includes physical exams, blood tests, and imaging studies like MRI to evaluate the size and number of brain metastases.

You will be required to attend scheduled visits for these assessments, and any changes in your health will be closely monitored.

5 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the study medications. This will include a review of any side effects experienced and the effectiveness of the treatment in managing your condition.

6 post-study follow-up

After completing the study, follow-up visits may be scheduled to monitor your long-term health and any lasting effects of the treatment. The duration of this follow-up period will depend on the study protocol and your healthcare provider’s recommendations.

Who Can Join the Study?

The patient has Stage IV, M1D melanoma. This means the cancer has spread to other parts of the body, including the brain.
The patient is neurologically asymptomatic from brain metastases. This means they do not have symptoms affecting the brain.
The patient has not received systemic corticosteroid therapy in the 10 days before starting the study. These are medications that reduce inflammation in the body.
If the patient is male and can produce sperm, they agree to use contraception or abstain from sexual intercourse during the study and for a certain period after the last dose of the study medication.
If the patient is female, they are not pregnant or breastfeeding. They must use a highly effective contraceptive method or abstain from heterosexual intercourse during the study and for a certain period after the last dose of the study medication.
The patient has adequate organ function. This means their organs, like the liver and kidneys, are working well enough to participate in the study.
Female patients agree not to breastfeed during the study and for a certain period after the last dose of the study medication.

Who Cannot Join the Study?

Patients with other serious health conditions that could interfere with the study.
Patients who have had another type of cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread).
Patients who are pregnant or breastfeeding.
Patients who have had a severe allergic reaction to similar treatments in the past.
Patients who are currently participating in another clinical trial.
Patients with active infections that require treatment.
Patients with certain heart conditions that are not well controlled.
Patients with a history of certain autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have received certain treatments for their cancer within a specific time frame before the study.
Patients with brain metastases that are causing symptoms or require treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Clinic De Barcelona	Barcelona	Spain
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
CHU Bordeauxt	Bordeaux	France
Lsymd Gipablw Hjqfwabq Oj Asxdwr	Athens	Greece
Aesldrsazr Pydijwxo Htfjflam Db Mzhurpeti	Marseille	France
Atalfxf Ostyrneswtw Uskgqaoogsjov Stqthk	Siena	Italy
Ajzbew Mzosoxd Cxwkgg Swqp	Thessaloniki	Greece
Naxcwxxk Ixksqsli Ofrimhdpq Iqm Mdjcj Spklnezuqyrvbbfinmvsqksmektt Ibkczldz Bpewghca	Cracow	Poland
Uqajdxwqowfeut Clwvcac Kszochtyv	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	26.04.2021
Greece	Not recruiting	26.04.2021
Hungary	Not recruiting	26.04.2021
Italy	Not recruiting	26.04.2021
Poland	Not recruiting	26.04.2021
Spain	Not recruiting	26.04.2021

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. Pembrolizumab targets a specific protein on the surface of cells, which can help your immune system recognize and attack cancer cells more effectively. This medication is used in the trial to see if it can help treat melanoma, a type of skin cancer, either on its own or in combination with other investigational treatments.

Advanced Melanoma with Brain Metastases – This is a type of skin cancer that has spread to the brain. Melanoma originates in the pigment-producing cells of the skin and is known for its aggressive nature. When it advances, it can metastasize, or spread, to other parts of the body, including the brain. Brain metastases occur when cancer cells travel through the bloodstream and form new tumors in the brain. The progression involves the growth of these metastatic tumors, which can affect brain function and cause neurological symptoms. The disease can continue to progress with the development of additional brain lesions and increased tumor size.

Trial ID:

2023-506315-17-00

Protocol code:

MK-3475-02D

NCT ID:

NCT04700072

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Pembrolizumab, Lenvatinib, and Quavonlimab for Patients with Advanced Melanoma with Brain Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?