Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

10 criteria

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 trial?

10 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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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.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy used to treat various types of cancer, including melanoma. The main therapeutic indication for pembrolizumab in this trial is for patients with PD-1 refractory melanoma. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. It is classified as a monoclonal antibody and is part of the broader category of immune checkpoint inhibitors.

Investigated diseases

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.