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Study of LTX-315 and Pembrolizumab for Patients with Advanced Melanoma Resistant to PD-1/PD-L1 Therapy

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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 a treatment for advanced melanoma, a type of skin cancer that has spread to other parts of the body and is difficult to treat. The study involves two medications: LTX-315, which is injected directly into the tumor, and pembrolizumab, also known by its code name MK-3475, which is given through an intravenous infusion. Pembrolizumab is a type of medication that helps the immune system fight cancer cells. The purpose of the study is to evaluate the effectiveness of these medications when used together in patients whose melanoma has not responded to previous treatments targeting proteins called PD-1 and PD-L1.

Participants in the study will receive the combination of LTX-315 and pembrolizumab over a period of time. The study will monitor the response of the cancer to the treatment, as well as any side effects that may occur. The treatment period for LTX-315 is up to 29 days, while pembrolizumab is administered over a longer period. Patients will have regular check-ups to assess their health and the progress of the treatment. The study aims to see if this combination can help shrink the tumors or stop them from growing.

In addition to the main medications, some patients may also receive other treatments like cimetidine, chlorphenamine, or montelukast, which are taken orally. These medications are used to manage symptoms or side effects. The study will also look at how the treatment affects the overall health of the participants, including changes in vital signs and any laboratory test results. The goal is to find a new way to help patients with advanced melanoma who have not had success with other treatments.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.
During this visit, you will undergo a series of tests to confirm your eligibility, including blood tests and a review of your medical history.
Step 2
Screening and baseline assessments
You will undergo a comprehensive screening process to ensure you meet all the study requirements. This includes laboratory tests, imaging studies, and a physical examination.
Baseline assessments will be conducted to gather initial data on your health status before starting the treatment.
Step 3
Treatment initiation
The treatment phase begins with the administration of LTX-315 through an injection directly into the tumor. This is known as intratumoral use.
You will also receive pembrolizumab through an intravenous infusion. This involves receiving the medication directly into your bloodstream through a vein.
Step 4
Treatment schedule
The LTX-315 injections will be administered according to the schedule set by the study team. The frequency and duration will be explained to you during your visits.
The pembrolizumab infusions will be given every three weeks. Each infusion session will last approximately 30 minutes.
Step 5
Regular follow-up visits
You will have regular follow-up visits to monitor your response to the treatment and to check for any side effects. These visits will include physical exams, blood tests, and imaging studies.
The study team will assess your health and adjust the treatment plan if necessary.
Step 6
End of treatment and final assessments
At the end of the treatment period, you will undergo final assessments to evaluate the overall effects of the treatment on your condition.
These assessments will include a comprehensive review of your health status and any changes observed during the study.
Step 7
Post-treatment follow-up
After completing the treatment, you will have follow-up visits to monitor your long-term health and any lasting effects of the treatment.
The study team will provide guidance on any additional care or monitoring needed after the trial.

Who can join the trial?

25 criteria

Have a confirmed diagnosis of advanced melanoma, which is a type of skin cancer that has spread to other parts of the body.
Have previously received treatment with anti-PD-1 or anti-PD-L1 therapy, which are types of cancer treatments, and the cancer has worsened after this treatment.
If you have a BRAF mutation (a specific genetic change in the cancer), you should have received treatment with a BRAF inhibitor before joining the study, unless you refused this treatment.
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Meet specific blood test requirements, including:
- Enough neutrophils (a type of white blood cell) in your blood.
- Enough lymphocytes (another type of white blood cell) in your blood.
- Enough platelets (cells that help with blood clotting) in your blood.
- Enough hemoglobin (a protein in red blood cells) in your blood.
- Normal prothrombin time and partial thromboplastin time, which are tests that measure how well your blood clots.
- Normal levels of bilirubin, AST, and ALT, which are substances measured to check liver function.
- Normal creatinine clearance, which measures kidney function.
- Normal levels of lactate dehydrogenase (LDH), an enzyme that can be a marker of tissue damage.
- Normal levels of serum albumin, a protein in the blood.
- Be willing and able to follow the study procedures and attend follow-up visits.
- Be willing to have a tumor biopsy, which is a procedure to remove a small sample of the tumor for testing.
- Be fully informed about the study and have signed the informed consent form, which is a document that explains the study and your rights as a participant.
- Agree to use contraceptive measures as required by the study if you or your partner could become pregnant.
- If you are a female, you must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
- Your disease should not be treatable with further radiotherapy or surgery.
- Have at least one superficial tumor that can be injected with the study drug. This means the tumor is close to the surface of the skin and not located deep inside the body.
- Have at least one measurable tumor that will not be injected with the study drug, which can be used to assess the effect of the treatment.
- Have a life expectancy of at least 3 months.
- Be at least 18 years old.
- Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
- Have recovered from any previous treatment-related side effects to a mild level, except for hair loss or mild nerve damage.
- Have a normal left ventricular ejection fraction (LVEF), which is a measure of heart function.

Who cannot join the trial?

2 criteria

Patients who have not failed or are not resistant to **anti-PD-1/PD-L1 therapy**. This means the treatment that blocks certain proteins on cells, which can help the immune system kill cancer cells, must not have worked for you.
Patients who do not have **advanced melanoma**. This is a type of skin cancer that has spread to other parts of the body.

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Verified sites

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

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Centre Hospitalier Lyon Sud
Pierre Benite, France
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Centre Hospitalier Universitaire De Lille
Lille, France
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Hospital Universitario De Navarra
Pamplona, Spain

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Investigated drugs

LTX-315
is a medication that is injected directly into tumors. It is designed to help the body's immune system recognize and attack cancer cells. By doing this, it aims to shrink the tumors and stop the cancer from growing. This medication is being tested to see if it can work well with another treatment to help patients with advanced melanoma, a type of skin cancer.
Pembrolizumab
is a type of cancer treatment known as an immunotherapy. It works by helping the immune system fight cancer cells. Pembrolizumab blocks a specific protein on the surface of cells that can stop the immune system from attacking cancer. By blocking this protein, pembrolizumab allows the immune system to better target and destroy cancer cells. It is used in this trial to see if it can work together with LTX-315 to treat advanced melanoma in patients who have not responded to other treatments.

What is already known about the treatment

LTX-315
LTX-315 is administered through an injection directly into the tumor, known as an intratumoral injection. It is currently being studied in clinical trials for its potential use in treating advanced melanoma, particularly in patients who have not responded to other therapies targeting PD-1/PD-L1. The medication works by disrupting the tumor cell membranes, which helps the immune system recognize and attack the cancer cells. LTX-315 is classified as an oncolytic peptide, a type of drug that targets and destroys cancer cells.
Pembrolizumab
Pembrolizumab is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. It is an established medication in the treatment of various cancers, including advanced melanoma, and is well-documented in medical literature. The main therapeutic use of pembrolizumab is to help the immune system fight cancer by blocking a protein called PD-1, which can prevent immune cells from attacking cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

Investigated diseases

Advanced Melanoma – Advanced melanoma is a form of skin cancer that occurs when the pigment-producing cells known as melanocytes become cancerous. It typically begins as a mole or a dark spot on the skin, which can change in size, shape, or color. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, lungs, liver, brain, and bones. This spread, known as metastasis, can lead to a variety of symptoms depending on the organs affected. The progression of advanced melanoma can vary, with some cases spreading rapidly while others may progress more slowly. The disease is often characterized by its ability to evade the immune system, making it challenging to control.