Not recruiting

Study on the Effects of AS01B, Ipilimumab, and Nivolumab in Patients with Advanced 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 advanced melanoma, a type of skin cancer that has spread to other parts of the body. The study involves the use of two medications: Opdivo (also known as nivolumab) and Yervoy (also known as ipilimumab). These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein. The trial also explores the use of a special type of immune cell called myeloid dendritic cells, which are injected directly into the tumor.

The purpose of the study is to evaluate how effective and safe these treatments are when used together. Participants in the trial will receive either the combination of Opdivo and Yervoy with or without the additional injection of myeloid dendritic cells. The study will monitor the participants over time to see how their cancer responds to the treatment and to track any side effects they may experience.

Throughout the study, participants will receive regular infusions and injections as part of their treatment plan. The trial aims to understand if this combination of treatments can help control the growth of the cancer and improve the quality of life for those with advanced melanoma. The study will continue until the end of 2025, with ongoing assessments to gather important information about the treatment's impact on the disease.

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
Joining the study
Upon joining the study, informed consent is required. This means agreeing to participate after understanding the study's purpose and procedures.
Eligibility is confirmed based on specific criteria, such as age, cancer type, and previous treatments.
Step 2
Initial assessments
Initial assessments include medical history review, physical examination, and laboratory tests to ensure eligibility.
A tumor sample is required, either from a recent biopsy or a new one if necessary.
Step 3
Treatment phase
The treatment involves two main medications: nivolumab and ipilimumab, both administered as solutions for infusion.
Nivolumab is given intravenously, meaning it is injected into a vein.
Ipilimumab is also administered intravenously.
The treatment may include additional components like intratumoral injections, which are injections directly into the tumor.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the treatment's effects and any side effects.
This includes physical exams, imaging tests, and laboratory tests.
The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the cancer does not worsen.
Step 5
End of study participation
Participation continues until the study's end date or if the treatment is no longer beneficial.
Final assessments are conducted to gather data on the treatment's long-term effects.

Who can join the trial?

13 criteria

The patient must have given their permission to participate in the study by signing a consent form.
The patient needs to have good blood vessel access for a procedure called leukapheresis, which involves collecting white blood cells.
The patient must be at least 18 years old.
The patient must have advanced cancer that cannot be completely removed by surgery and has not responded to standard treatments.
The patient must have cancer that has spread to areas that can be safely injected with treatment, using methods like ultrasound or CT scans. These areas should also be safe for a biopsy, which is a procedure to take a small sample of tissue.
The patient must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
The patient must be suitable for treatment directly into the tumor, with at least one tumor that is 10 mm or larger, or multiple tumors that together measure 10 mm or more.
The patient must have adequate organ function, which includes:
- Enough white blood cells, platelets, and hemoglobin in the blood.
- Normal kidney function, shown by creatinine levels.
- Normal liver function, shown by bilirubin and liver enzyme levels.
- Normal blood clotting ability, unless on blood-thinning medication.
- If the patient is a woman who can have children, she must have a negative pregnancy test before joining the study.
- The patient must provide a sample of their tumor, either from a previous biopsy done within the last 3 months or a new biopsy. If the sample is not usable, a new biopsy may be needed.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than solid tumors cannot participate. Solid tumors are a type of cancer that forms in solid organs or tissues.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special protection.
Patients who do not meet the specific health conditions required for the study cannot participate. The specific health conditions are not detailed in the provided data.
Patients who are not eligible based on gender cannot participate. Both male and female patients are eligible for this study.

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Verified sites

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Vrije Universiteit Brussel
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Jette, Belgium

Trial locations

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Investigated drugs

AS01B
is an adjuvant used in this trial. It is designed to enhance the body's immune response against cancer cells. In this study, it is administered directly into the tumor to help boost the effectiveness of other cancer treatments.
Ipilimumab
is a medication that works by blocking a protein called CTLA-4. This helps the immune system attack cancer cells more effectively. In this trial, ipilimumab is given directly into the tumor to target the cancer more precisely.
Nivolumab
is a medication that blocks a protein called PD-1. By doing this, it helps the immune system recognize and destroy cancer cells. In this study, nivolumab is given through an intravenous infusion to help treat advanced melanoma.
Autologous CD1c(BDCA-1)+ / CD141(BDCA-3)+ Myeloid Dendritic Cells
are specialized immune cells taken from the patient's own body. These cells are used to help stimulate the immune system to fight the cancer. In this trial, they are administered directly into the tumor to enhance the immune response against melanoma.

What is already known about the treatment

AS01B
This medication is administered intratumorally and is currently being studied in clinical trials for its potential use in treating solid tumors, particularly advanced melanoma. It is combined with other treatments to enhance the immune response against cancer cells. AS01B works by acting as an adjuvant, which means it helps boost the body's immune response to fight the tumor more effectively. It is classified as an immunological adjuvant in pharmacology.
Ipilimumab
Administered intratumorally, ipilimumab is an established medication used in the treatment of certain types of cancer, including melanoma. It is a monoclonal antibody that works by inhibiting CTLA-4, a protein receptor that downregulates the immune system, thereby enhancing the body's ability to attack cancer cells. Ipilimumab is classified as an immune checkpoint inhibitor.
Nivolumab
This medication is given intravenously and is widely used in the treatment of various cancers, including melanoma. Nivolumab is a monoclonal antibody that blocks the PD-1 protein on immune cells, preventing cancer cells from evading the immune system. It is classified as an immune checkpoint inhibitor.
Autologous CD1c(BDCA-1)+ / CD141(BDCA-3)+ Myeloid Dendritic Cells
These are specialized immune cells administered intratumorally, currently under investigation in clinical trials for their role in treating solid tumors like melanoma. They are derived from the patient's own body and are used to enhance the immune response against cancer by presenting tumor antigens to T-cells, thereby stimulating a targeted immune attack. These cells are part of the immunotherapy classification.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially causing functional impairments. The growth rate and behavior of solid tumors can vary widely depending on their type and location. They are distinct from blood-related cancers, such as leukemia, which do not form solid masses.