Study on the Safety and Effectiveness of Pembrolizumab and Tretinoin in Patients with PD-1 Refractory 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 several investigational treatments, including pembrolizumab (also known as MK-3475), which is a medication that helps the immune system fight cancer. Other treatments being tested in combination with pembrolizumab include tretinoin, quavonlimab (MK-1308A), favezelimab (MK-4280A), lenvatinib (MK-7902), and vibostolimab (MK-7684). These treatments are being studied to see how safe and effective they are when used together or alone in people with melanoma that has not responded to previous treatments.

The purpose of this study is to assess the safety and effectiveness of these treatment combinations. Participants will receive the treatments either through capsules taken by mouth or through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor participants for any side effects and measure how well the cancer responds to the treatments. The study will also evaluate how long any positive effects last.

Participants in this study have melanoma that is not treatable with surgery and have not received prior treatment for advanced stages of the disease. The study will continue over several years to gather comprehensive data on the safety and effectiveness of these treatments. The goal is to find new ways to help people with melanoma, especially those whose cancer has not responded to other treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of melanoma that cannot be treated with local therapy and ensuring no prior treatment for advanced disease.

A tumor biopsy is required to proceed.

2 safety lead-in phase

The safety lead-in phase aims to evaluate the safety and tolerability of the treatment combinations. This involves monitoring for any adverse effects.

During this phase, the percentage of participants experiencing dose-limiting toxicity or adverse events is assessed.

3 treatment administration

Participants receive treatments that may include pembrolizumab alone or in combination with investigational agents.

Medications such as tretinoin (oral use), pembrolizumab (intravenous infusion), lenvatinib (oral use), and vibostolimab (intravenous infusion) are administered according to the study protocol.

4 monitoring and evaluation

Participants are regularly monitored for adverse events and treatment efficacy. This includes evaluating the objective response rate using specific criteria.

The duration of response is also assessed to determine the effectiveness of the treatment.

5 conclusion of participation

The study is estimated to conclude by July 2030. Participants will be informed of their results and any further steps if applicable.

Participants are required to continue using contraception for a specified period after the last dose of study intervention, depending on the medication received.

Who Can Join the Study?

The patient must have a type of skin cancer called melanoma that has been confirmed through specific tests.
The melanoma must be at a stage where it cannot be removed by surgery, specifically Stage III or Stage IV.
The patient should not have received treatment for advanced melanoma before.
The patient must provide a sample of their tumor for testing.
If the patient is a male capable of producing sperm, he must agree to either not engage in sexual intercourse or use birth control during the study and for a short period after the last dose of the study medication.
If the patient is a female, she must not be pregnant or breastfeeding. She must either not be of childbearing potential or use effective birth control during the study and for a specified time after the last dose of the study medication. The time varies depending on the medication used.
The patient must have organs that are functioning well enough to participate in the study.
The patient must have recovered from any side effects of previous treatments to a mild level, except for hair loss or mild nerve damage.

Who Cannot Join the Study?

Patients who have not been diagnosed with PD-1 refractory melanoma. This is a type of skin cancer that does not respond to certain treatments targeting the PD-1 protein.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures and requirements.
Patients who have other medical conditions that might interfere with the study treatment or outcomes.
Patients who are pregnant or breastfeeding, as the study may involve treatments that could affect the baby.
Patients who are participating in another clinical trial at the same time, which could affect the results of this study.
Patients who have had a recent major surgery or are recovering from a major illness.
Patients who have a history of severe allergic reactions to any of the study medications.
Patients who have an active infection that requires treatment.
Patients who have a history of drug or alcohol abuse that could interfere with the study.

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
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
CHU Bordeauxt	Bordeaux	France
Lnfkj Gcnkrej Hddonljj Oz Aacpto	Athens	Greece
Asjnbjmffs Paiczkow Hwbhgkwp Dt Mhqbzpnea	Marseille	France
Avbuhdn Ovvkqgymxln Uyyxhbegiblsg Sadtkz	Siena	Italy
Nlblcqwd Ijanssxt Owphkwhrx Izz Mwzyh Swagaapbqjjbtcilctxrfxywdygm Ipvrbves Bkxrzesr	Cracow	Poland
Uqrbbkufqzpqrn Cvenxgj Kjcnlttcz	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.07.2020
Greece	Not recruiting	01.07.2020
Hungary	Not recruiting	01.07.2020
Italy	Not recruiting	01.07.2020
Poland	Not recruiting	01.07.2020
Spain	Not recruiting	01.07.2020

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the body’s immune system fight melanoma, a type of skin cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

Investigational Agents are new treatments being tested in this trial. These agents are not yet approved for general use and are being studied to see how well they work and how safe they are when used alone or in combination with pembrolizumab. The goal is to find new ways to treat melanoma more effectively.

PD-1 Refractory Melanoma – This is a type of skin cancer that does not respond to treatments targeting the PD-1 protein, which is involved in regulating the immune system. Melanoma begins in the melanocytes, the cells responsible for producing the pigment melanin, which gives skin its color. In its refractory form, the cancer persists despite attempts to block PD-1, a checkpoint protein on immune cells that normally helps keep the body’s immune responses in check. The disease can spread to other parts of the body, making it more challenging to manage. It often requires alternative therapeutic strategies due to its resistance to standard PD-1 inhibitors. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:

2023-506313-21-00

Protocol code:

MK-3475-02B

NCT ID:

NCT04305054

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Pembrolizumab and Tretinoin in Patients with PD-1 Refractory Melanoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?