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Study of LTX-315 and Pembrolizumab for Patients with Resectable Stage III-IV Melanoma

Verified siteInvestigationalNo 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 melanoma, a type of skin cancer that can spread to other parts of the body. The study involves patients with stage III or IV melanoma, which means the cancer is advanced but can still be surgically removed. The treatment being tested combines two medications: LTX-315 and pembrolizumab. LTX-315 is a chemical injected directly into the tumor, while pembrolizumab, also known as Keytruda, is a monoclonal antibody given through an intravenous infusion. Monoclonal antibodies are proteins designed to help the immune system fight cancer.

The purpose of the study is to observe how well the combination of LTX-315 and pembrolizumab works in shrinking the tumors before surgery. Participants will receive these treatments over a period of time, and doctors will monitor the response of the tumors. The study aims to see if the tumors can be reduced in size, making them easier to remove surgically. The trial will also look at the safety of the treatment and any side effects that may occur.

Throughout the study, participants will undergo regular check-ups and tests to assess the effectiveness of the treatment and to ensure their well-being. The ultimate goal is to improve the outcomes for patients with advanced melanoma by using this combination of treatments before surgery. This approach is known as neoadjuvant therapy, which means treatment given as a first step to shrink a tumor before the main treatment, usually surgery, is performed.

The research process

The trial runs in 6 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 a review of medical history and a physical examination.
Eligibility criteria include being 18 years or older, having stage III-IV melanoma that is detectable and resectable, and being medically fit for surgery.
Step 2
Treatment preparation
Before starting treatment, a tumor biopsy is required. This involves taking a small sample of the tumor tissue for analysis.
Participants must have at least one lesion suitable for injection, with specific size requirements.
Step 3
Treatment phase
The treatment involves two medications: pembrolizumab and LTX-315.
Pembrolizumab is administered as an intravenous infusion. The dosage and frequency are determined by the study protocol.
LTX-315 is injected directly into the tumor. The frequency and dosage are specified in the study protocol.
Step 4
Surgery
After the treatment phase, surgery is performed to remove the tumor. The timing of the surgery is based on the response to the treatment.
The goal is to achieve a complete removal of the tumor.
Step 5
Post-surgery evaluation
Following surgery, an evaluation is conducted to assess the response to the treatment. This includes analyzing the removed tumor tissue.
The primary measure of success is the rate of complete pathological response, which indicates no remaining cancer cells in the tissue.
Step 6
Follow-up
Regular follow-up visits are scheduled to monitor recovery and check for any signs of cancer recurrence.
These visits include physical examinations and possibly imaging tests to ensure the cancer has not returned.

Who can join the trial?

15 criteria

The participant must be at least 18 years old when signing the consent form.
The participant must have a type of skin cancer called **melanoma** that is at stage III or IV, which means it is advanced but can still be removed by surgery. This must be confirmed by a group of doctors who specialize in treating tumors. The melanoma can be on the skin, including areas like the palms or soles, or in mucous areas like the mouth or eyes. It must be visible and measurable by scans or physical exams.
The disease must be measurable according to specific guidelines called **RECIST version 1.1**.
The participant must be considered healthy enough to have the planned surgery by the surgical team.
The participant must have a performance status of 0 or 1 on the **Eastern Cooperative Oncology Group (ECOG)** scale, which means they are fully active or have some symptoms but do not need to stay in bed.
The participant must have at least one skin, under-the-skin, or lymph node lesion that can be injected, with a size not larger than 3.0 cm.
The participant must agree to have an extra tumor biopsy and provide samples from the biopsy and surgery.
The participant must have adequate organ function, which includes:
- Hemoglobin level greater than 9 g/dL
- White blood cell count (specifically **neutrophils**) of at least 1.0 x 10⁹/L
- Platelet count of at least 80 x 10⁹/L
- **Bilirubin** level no more than 1.5 times the normal upper limit
- **AST** and **ALT** levels no more than 2.5 times the normal upper limit
- **Albumin** level greater than 30 g/L
- **Creatinine** level no more than 1.5 times the normal upper limit or a creatinine clearance greater than 30 mL/min
- The participant must be able to give signed informed consent, meaning they understand and agree to the study's requirements.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have already received treatment for their melanoma that might affect the study results.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of drug or alcohol abuse that could affect their ability to participate.
Patients who have an active infection that requires treatment.
Patients who have had a major surgery recently and have not fully recovered.

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Verified sites

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Helse Bergen HF
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Bergen, Norway
Oslo Universitetssykehus HF
Verified
Oslo, Norway

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Investigated drugs

LTX-315
is an experimental medication being studied for its potential to treat melanoma, a type of skin cancer. It is used in this trial as a neoadjuvant treatment, which means it is given before the main treatment to help shrink the tumor. LTX-315 is designed to stimulate the immune system to attack cancer cells more effectively.
Pembrolizumab
is a medication that helps the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to recognize and destroy them. In this trial, pembrolizumab is used in combination with LTX-315 to enhance the overall treatment effect against melanoma.

Ruxotemitide

What is already known about the treatment

LTX-315
This medication is administered through direct injection into the tumor. It is currently being studied in clinical trials for its potential use in treating advanced melanoma, specifically in patients with stage III-IV melanoma that can be surgically removed. LTX-315 works by disrupting the tumor cell membranes, leading to cell death and stimulating an immune response against the cancer. It is classified as an oncolytic peptide, which is a type of cancer treatment that uses peptides to target and destroy cancer cells.
Pembrolizumab
This medication is given as an intravenous infusion. It is widely used and well-documented in medical literature as an effective treatment for various types of cancer, including melanoma. Pembrolizumab is primarily indicated for patients with advanced melanoma and works by blocking a protein called PD-1 on immune cells, thereby enhancing the body's immune response against cancer cells. It belongs to a class of drugs known as immune checkpoint inhibitors, which help the immune system recognize and attack cancer cells.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It is characterized by the uncontrolled growth of these cells, often appearing as a new or changing mole on the skin. Melanoma can occur anywhere on the body but is most commonly found on areas exposed to the sun, such as the back, legs, arms, and face. As it progresses, melanoma can invade nearby tissues and spread to other parts of the body, including the lymph nodes and internal organs. Early stages may be limited to the skin, but advanced stages involve deeper tissue invasion and potential metastasis. Regular skin checks and awareness of changes in moles or skin appearance are crucial for early detection.