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Study of Ipilimumab and Nivolumab with or without Radiotherapy for Patients with Melanoma Brain Metastases

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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 melanoma brain metastases, which is a condition where melanoma, a type of skin cancer, spreads to the brain. The study will use two medications: YERVOY (also known as ipilimumab) and OPDIVO (also known as nivolumab). These medications are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to compare the effects of using these medications alone versus using them together with a type of targeted brain radiation called stereotactic radiotherapy. This study aims to understand how these treatments can help manage the disease and improve outcomes for patients with melanoma that has spread to the brain.

Participants in the study will receive either the combination of medications and radiation or just the medications. The study will monitor the effects of these treatments over time, focusing on how they impact the brain metastases and overall health. The trial will also look at the rate of neurological-specific death, which refers to deaths caused by brain-related issues, at one year after starting treatment. The study will continue to gather information and follow participants for several years to understand the long-term effects of these treatments.

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, a physical examination, and necessary imaging tests such as an MRI with a contrast agent. Blood tests are performed to ensure adequate organ function.
Participants must meet specific criteria, including being at least 18 years old, having a life expectancy of more than 30 days, and having a confirmed diagnosis of melanoma with brain metastases.
Step 2
Treatment initiation
The treatment involves the administration of two medications: ipilimumab and nivolumab. Both are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.
The specific dosage and frequency of these medications are determined by the study protocol and will be explained by the healthcare team.
Step 3
Treatment with or without radiotherapy
Participants are randomly assigned to receive either the combination of ipilimumab and nivolumab alone or with additional stereotactic radiotherapy, a type of targeted radiation treatment for brain metastases.
The decision on whether to include radiotherapy is based on the study's randomization process and the treating clinician's assessment.
Step 4
Ongoing monitoring
Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes imaging tests, such as MRI scans, to evaluate changes in brain metastases.
Participants are also monitored for any side effects or adverse reactions to the treatment. The healthcare team will provide guidance on managing any symptoms that arise.
Step 5
Follow-up assessments
Follow-up assessments are scheduled at specific intervals to evaluate the effectiveness of the treatment and monitor overall health. These assessments may include additional imaging tests and blood work.
The study aims to measure outcomes such as the response of brain metastases to treatment and the overall survival rate at one year.
Step 6
End of trial participation
At the end of the trial, a final assessment is conducted to gather data on the long-term effects of the treatment. Participants may be asked to continue follow-up visits to monitor their health status.
The study is expected to conclude by December 2032, but individual participation may end earlier depending on personal health outcomes and study requirements.

Who can join the trial?

14 criteria

Must be 18 years of age or older.
Must have a life expectancy of more than 30 days.
Must be able to undergo an MRI scan with a special dye called Gadolinium.
Must have adequate blood, liver, and kidney function.
Women who can have children must have a negative pregnancy test and use effective birth control.
Men with female partners who can have children must use effective birth control and not donate sperm during the study and for 31 weeks after treatment ends.
Must provide written informed consent to participate in the study.
Must have a specific type of skin cancer called melanoma that has spread to the brain and cannot be removed by surgery. The brain tumors must be between 5mm and 40mm in size and measurable by specific guidelines. There is no limit to the number of brain tumors.
Must know their BRAF mutation status before being randomly assigned to a treatment group. BRAF is a gene that can affect cancer growth.
The doctor should consider treating all brain tumors with stereotactic radiotherapy (a precise form of radiation therapy) instead of whole brain radiotherapy. This includes brain tumors that are 5mm or smaller.
Must not have had prior radiotherapy for brain tumors. Previous surgery for melanoma brain tumors is allowed. Radiotherapy for cancer outside the brain is allowed.
Must not have had prior drug therapy for melanoma, unless it was given before or after surgery for cancer outside the brain. There must be proof that there were no brain tumors during previous drug treatment. The brain tumors must have appeared at least 6 months after stopping previous drug treatment. Previous treatments like anti PD1, anti PD-L1, anti CTLA-4, BRAF/MEK inhibitors, or clinical trial drugs are allowed if given before or after surgery.
Must have no symptoms from brain tumors at the time of joining the study and not be taking steroids, painkillers, or other treatments for active neurological symptoms. Resolved symptoms are allowed if they have been gone for at least 7 days before joining the study. Anti-seizure medications are allowed if the patient has no symptoms at the time of joining the study.
Must have an ECOG performance status of 0-2, which is a scale used to assess how well a patient can perform daily activities.

Who cannot join the trial?

4 criteria

Patients with **melanoma brain metastases** cannot participate. This means the cancer has spread to the brain.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Patients who are part of a **vulnerable population** cannot participate. This refers to groups who may need special protection, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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IRCCS Istituto Nazionale Tumori Fondazione Pascale
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Naples, Italy

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Investigated drugs

Ipilimumab
is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, ipilimumab is used to treat melanoma that has spread to the brain, aiming to improve the body's ability to fight the cancer.
Nivolumab
is another immune checkpoint inhibitor that helps boost the immune system's response against cancer cells. Like ipilimumab, it is used in this trial to treat melanoma brain metastases. The goal is to enhance the immune system's ability to target and destroy cancer cells in the brain.
Intracranial stereotactic radiotherapy
is a precise form of radiation therapy that targets tumors in the brain. It delivers high doses of radiation directly to the cancer cells while minimizing damage to the surrounding healthy tissue. In this trial, it is used in combination with ipilimumab and nivolumab to potentially improve treatment outcomes for patients with melanoma brain metastases.

What is already known about the treatment

Ipilimumab
Ipilimumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently used in medicine to treat certain types of cancer, including melanoma, and is well-documented in medical literature. The main therapeutic indication for ipilimumab is to help the immune system attack and destroy cancer cells. At the molecular level, it works by blocking a protein called CTLA-4, which normally helps keep immune cells in check, thereby boosting the immune response against cancer cells. Ipilimumab is classified as an immune checkpoint inhibitor.
Nivolumab
Nivolumab is also administered as an intravenous infusion, delivered directly into the bloodstream through a vein. It is widely used in the treatment of various cancers, including melanoma, and is supported by extensive medical research. The primary therapeutic use of nivolumab is to enhance the body's immune response to fight cancer. It works by inhibiting a protein called PD-1 on immune cells, which allows these cells to better recognize and attack cancer cells. Nivolumab is classified as an immune checkpoint inhibitor.

Investigated diseases

Melanoma Brain Metastases – Melanoma brain metastases occur when melanoma cells spread from their original site to the brain. This condition is a result of melanoma, a type of skin cancer, that has advanced and disseminated through the bloodstream or lymphatic system. As the disease progresses, it can lead to the formation of tumors within the brain tissue. These tumors can cause various neurological symptoms, such as headaches, seizures, or changes in cognitive function, depending on their size and location. The progression of melanoma brain metastases can lead to increased pressure within the skull, affecting brain function. Over time, the condition may result in significant neurological impairment.