Study on the Safety and Effectiveness of Pembrolizumab, Vibostolimab, and Lenvatinib for Patients with PD-1 Refractory Melanoma

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What is this study about?

This clinical trial is focused on studying treatments for a type of skin cancer known as melanoma, specifically in cases where the cancer has not responded to previous treatments targeting a protein called PD-1. The study will explore the safety and effectiveness of different treatment combinations, including the use of pembrolizumab, also known as Keytruda, either alone or in combination with other investigational drugs. These investigational drugs include vibostolimab (MK-7684), lenvatinib (MK-7902), quavonlimab (MK-1308), and tretinoin. Pembrolizumab is administered as a solution for infusion, while lenvatinib and tretinoin are taken orally in capsule form.

The purpose of the study is to assess how safe and tolerable these treatment combinations are for participants, as well as to evaluate how well the treatments work in reducing the size of the tumors. Participants will receive these treatments over a period of time, and their health will be closely monitored to identify any side effects or improvements in their condition. The study will also include a group of participants who will receive a placebo to compare the effects of the investigational treatments.

Throughout the study, participants will undergo regular health assessments to track their response to the treatments. The study aims to provide valuable information on new potential treatment options for patients with melanoma that has not responded to existing therapies. This research could lead to improved treatment strategies for managing this challenging form of skin cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of melanoma and ensuring previous treatments have been resolved to a manageable level.

A tumor biopsy is required to provide a sample for analysis.

2 treatment initiation

The treatment phase begins with the administration of investigational drugs. These include vibostolimab, lenvatinib, pembrolizumab, tretinoin, and quavonlimab.

Vibostolimab, pembrolizumab, and quavonlimab are given through an intravenous infusion, which means they are delivered directly into the bloodstream.

Lenvatinib and tretinoin are taken orally in capsule form.

3 treatment schedule

The frequency and duration of each medication depend on the specific treatment plan assigned. The study aims to evaluate the safety and effectiveness of these combinations.

Participants are monitored for any adverse effects throughout the treatment period.

4 monitoring and evaluation

Regular assessments are conducted to monitor the response to treatment. This includes imaging tests to track the progression of melanoma.

The objective response rate is evaluated using specific criteria to determine the effectiveness of the treatment.

5 completion and follow-up

Upon completion of the treatment phase, a follow-up period is observed to assess the duration of response and any long-term effects.

Participants are required to adhere to specific guidelines regarding contraception and health monitoring during and after the study.

Who Can Join the Study?

The patient must have a type of skin cancer called melanoma, confirmed by a doctor through tests.
The patient must have recovered from side effects of their last treatment to a mild level, except for hair loss.
The patient must have advanced melanoma that cannot be removed by surgery, as per specific medical guidelines.
The patient must have had their cancer worsen after receiving a specific type of treatment called anti-PD-1/L1, either alone or with other treatments.
The patient must have medical images showing their cancer has worsened after starting anti-PD-1/L1 treatment, or if it worsened quickly during or after other treatments.
The patient must not have had more than three different treatments for their advanced melanoma.
The patient must provide a sample of their tumor for testing.
Male patients taking certain medications must either not engage in sexual activity with women or agree to use birth control during treatment and for a short time after.
Female patients must not be pregnant or breastfeeding and must either not be able to become pregnant or use effective birth control during treatment and for a specified time after.
The patient must have organs that are working well enough to participate in the study.

Who Cannot Join the Study?

Patients who have not responded to previous treatments for their melanoma, specifically those treatments that target a protein called PD-1.
Patients who have experienced severe side effects from similar treatments in the past.
Patients with other serious health conditions that could interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are currently participating in another clinical trial.
Patients with a history of certain types of cancer other than melanoma.
Patients with active infections that require treatment.
Patients with known allergies to the study medication or its ingredients.
Patients who have received certain medications or treatments within a specific time frame before the study starts.

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
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
CHU Bordeauxt	Bordeaux	France
Adyfbfpeke Pnydcevy Hhiepvqb Dc Mkffvbrla	Marseille	France
Abrefew Ooljdsjhjsd Uxwaxwjcxoscs Seogob	Siena	Italy

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.07.2020
Italy	Not recruiting	31.07.2020

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 to see if they are safe and effective for treating melanoma. These agents are not yet approved for general use and are being studied to understand how they work in combination with other treatments like pembrolizumab.

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 is known for its ability to spread to other parts of the body if not treated early. In cases where the cancer becomes refractory, it means that the disease continues to progress despite treatment efforts. This condition can be challenging to manage as it indicates resistance to a specific class of immunotherapy drugs. The progression of PD-1 refractory melanoma can vary, but it often involves the growth and spread of cancer cells. Understanding the mechanisms of resistance is crucial for developing new therapeutic strategies.

Trial ID:

2023-506312-41-00

Protocol code:

MK-3475-02A

NCT ID:

NCT04305041

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Pembrolizumab, Vibostolimab, and Lenvatinib for Patients with PD-1 Refractory Melanoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?