Recruiting

Study Comparing Ipilimumab and Nivolumab to Nivolumab Alone for Patients with Resectable Stage III 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 Stage III melanoma, a type of skin cancer that has spread to nearby tissues but not to distant parts of the body. The study will compare two different treatment approaches for this condition. One group of patients will receive a combination of two medications: YERVOY (also known as ipilimumab) and OPDIVO (also known as nivolumab). These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The other group will receive only OPDIVO as a single treatment.

The purpose of the study is to understand how well these treatments work in preventing the cancer from coming back or getting worse. Patients will be randomly assigned to one of the two treatment groups. The study will monitor patients over time to see how long they remain free of cancer progression, which means the cancer does not grow or spread further. The study will also look at how long patients live without the cancer returning after surgery and how long they live overall.

Throughout the study, researchers will collect information on any side effects experienced by patients and how these treatments affect their overall health. The study aims to provide valuable insights into the effectiveness of these treatments for Stage III melanoma, helping to improve future care for patients with this condition.

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
Joining the trial
Upon joining the trial, you will be informed about the study's purpose, procedures, and potential risks and benefits. You will be required to provide a signed informed consent, indicating your understanding and agreement to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have stage III melanoma that is resectable, meaning it can be surgically removed without significant complications. A negative pregnancy test is required for female participants of childbearing potential.
Step 3
Randomization
You will be randomly assigned to one of two treatment groups. One group will receive anti-PD-1 monotherapy, and the other will receive a combination of anti-CTLA-4 and anti-PD-1 therapy.
Step 4
Treatment administration
If you are in the monotherapy group, you will receive nivolumab (OPDIVO) as an intravenous infusion. If you are in the combination therapy group, you will receive both ipilimumab (YERVOY) and nivolumab as intravenous infusions. The specific dosage and frequency will be explained to you by the medical team.
Step 5
Monitoring and follow-up
Throughout the trial, you will undergo regular monitoring to assess your response to the treatment and to check for any side effects. This includes physical examinations, blood tests, and imaging studies as needed.
Step 6
Surgery
If the treatment is effective and your tumor remains resectable, you will undergo surgery to remove the melanoma. This is planned to occur within 10 weeks from the start of the treatment.
Step 7
Post-surgery follow-up
After surgery, you will continue to be monitored for any signs of melanoma recurrence or progression. Follow-up visits will be scheduled to ensure your recovery and to evaluate the long-term effects of the treatment.

Who can join the trial?

10 criteria

Participants must be at least 18 years of age.
No prior targeted therapy aimed at BRAF and/or MEK. These are specific proteins that some cancer treatments target.
Must be able to provide a signed informed consent, which means you understand the study and agree to participate.
Have a World Health Organization (WHO) Performance Status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
Must have Stage III melanoma confirmed by a doctor through tests. If you have small tumors that can be removed, you may still participate.
Women who can have children must have a negative pregnancy test before starting the study.
Women who can have children must agree to use a highly effective method of birth control during the study and for 150 days after the last dose of study medication. This can include methods like hormonal birth control, an intrauterine device (IUD), or having a partner who has had a vasectomy.
Men who can have children must agree to use an effective method of birth control during the study and for 150 days after the last dose of study medication. This can include having a partner who is postmenopausal or using a highly effective method of contraception.
No other cancers, unless they were treated successfully and you have a life expectancy of more than 5 years.
No prior immunotherapy targeting CTLA-4, PD-1, or PD-L1. These are proteins that some cancer treatments target to help the immune system fight cancer.

Who cannot join the trial?

7 criteria

Patients with any other type of cancer besides stage III malignant melanoma cannot participate. Malignant melanoma is a type of skin cancer, and stage III means it has spread to nearby lymph nodes.
Patients who have not had their melanoma surgically removed cannot participate. Resectable means the cancer can be removed by surgery.
Patients who are not able to receive immune checkpoint inhibitors cannot participate. These are drugs that help the immune system fight cancer.
Patients who have received similar treatments before cannot participate.
Patients with serious health conditions that could interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures cannot participate.

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Verified sites

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Karolinska University Hospital
Verified
Solna, Sweden
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

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Investigated drugs

Anti-PD-1 Monotherapy
is a type of treatment that helps your immune system fight cancer. It works by blocking a protein called PD-1 on the surface of certain immune cells. This protein can stop the immune system from attacking cancer cells. By blocking PD-1, this therapy allows the immune system to better recognize and destroy cancer cells, particularly in melanoma, a type of skin cancer.
Combined Anti-CTLA-4/Anti-PD-1 Blockade
is a treatment that uses two different medications to help the immune system attack cancer. One part of this treatment blocks a protein called CTLA-4, and the other part blocks the PD-1 protein. Both of these proteins can prevent the immune system from effectively fighting cancer. By blocking them, this combined therapy aims to enhance the immune system's ability to target and kill cancer cells, especially in cases of melanoma that can be surgically removed.

What is already known about the treatment

Anti-PD-1 Monotherapy
This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating stage III malignant melanoma. It works by blocking a specific protein on immune cells, which helps the body's immune system attack cancer cells more effectively. This medication is classified as an immune checkpoint inhibitor and is primarily used to treat certain types of cancer by enhancing the immune response against tumor cells.
Combined Anti-CTLA-4/Anti-PD-1 Blockade
This treatment involves the administration of two medications via injection, and it is being evaluated in clinical trials for patients with resectable stage III melanoma. The combination works by targeting two different proteins that regulate the immune system, thereby boosting the body's ability to fight cancer. This approach is also classified as an immune checkpoint inhibitor therapy and is used to improve the immune system's response to cancer cells.

Investigated diseases

Malignant melanoma stage III – Malignant melanoma stage III is a type of skin cancer that has spread to nearby lymph nodes but not to distant parts of the body. It begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As the disease progresses, cancer cells can invade nearby tissues and lymph nodes, leading to the formation of tumors. The spread to lymph nodes indicates a more advanced stage of the disease, which can complicate treatment and management. The progression of malignant melanoma can vary, with some cases remaining stable for a period, while others may advance more rapidly. Monitoring and regular check-ups are crucial to manage the disease effectively.