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Study of Nivolumab for Patients with Metastatic Solid Tumors and Leptomeningeal Disease

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 a condition known as leptomeningeal disease, which occurs when cancer spreads to the membranes surrounding the brain and spinal cord. The study is investigating a treatment using a medication called nivolumab, also known by its code name BMS936558. Nivolumab is a type of drug that helps the immune system fight cancer cells. In this trial, the medication is given directly into the fluid around the brain and spinal cord, a method known as intrathecal administration.

The purpose of the study is to determine the highest dose of nivolumab that can be safely given in this way and to assess its safety. Participants in the study will receive the medication and be monitored for any side effects. Some participants may receive a placebo instead of the actual medication. The study will also look at how long participants live after receiving the treatment.

Throughout the study, participants will undergo regular check-ups and tests, including MRI scans, to monitor their condition and the effects of the treatment. The study aims to provide valuable information on the potential benefits and risks of using nivolumab for treating leptomeningeal disease in patients with metastatic solid tumors.

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, the patient will undergo a neurological examination using the NANO scale and an MRI assessment based on the LANO scorecard.
The patient must be able to undergo intrathecal therapy via an intraventricular catheter, such as an Ommaya reservoir.
Step 2
Initial assessments
A thorough evaluation of the cerebrospinal fluid (CSF) is required to confirm the diagnosis of leptomeningeal disease (LMD). This includes checking for malignant cells in the CSF.
An MRI will be conducted to identify any pial enhancement or nodular manifestations, which are indicative of LMD.
Step 3
Treatment administration
The patient will receive the medication OPDIVO, which contains the active substance nivolumab, administered as a solution for infusion.
The medication is given intrathecally, meaning it is delivered directly into the spinal canal.
Step 4
Monitoring and follow-up
The patient will be monitored to assess the maximum tolerable dose and safety of the treatment.
Regular follow-up visits will be scheduled to evaluate the patient's overall survival and response to the treatment.
Step 5
End of trial
The trial is expected to conclude by September 30, 2026.
Upon completion, the patient will undergo final assessments to determine the outcomes of the treatment.

Who can join the trial?

14 criteria

Must be at least 18 years old at the time of signing the informed consent.
Undergo a neurological examination using the NANO scale, which is a way to check brain and nerve function.
Have an MRI scan evaluated using the LANO scorecard, a method to assess brain images.
Be able to receive treatment directly into the spinal fluid through a special device called an intraventricular catheter, like an Ommaya reservoir.
Provide a sample of the primary tumor tissue for testing, if possible, before the end of the trial.
If a female patient can have children, or if a male patient has a female partner who can have children, they must agree to use very effective birth control methods during treatment and for 150 days after the last dose.
Understand and willingly sign a consent form before any study-related procedures.
Have a "good risk" status as defined by specific medical guidelines.
Have a tumor board protocol that confirms the need for the treatment and evaluates trial enrollment.
Be able to follow the study visit schedule and other study requirements.
Agree not to donate blood while on the study drug and for 28 days after stopping the treatment.
Have a Karnofsky performance score greater than 50%, which measures the ability to perform daily activities.
Have a diagnosis of LMD (leptomeningeal disease) confirmed by tests on the spinal fluid (CSF) and/or MRI scans.
If radiation therapy was received, ensure documentation of the treatment is available, and it must have been completed more than 2 weeks before joining the trial.

Who cannot join the trial?

4 criteria

Patients with **leptomeningeal disease** cannot participate. This is a condition where cancer spreads to the membranes surrounding the brain and spinal cord.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who do not meet the gender requirements of the study cannot participate. The study includes both male and female participants.
Patients who are considered part of a vulnerable population cannot participate. This means individuals who might need special protection or care.

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Verified sites

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

Verified
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
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Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
Verified
Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany

Trial locations

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Investigated drugs

PD-1 Antibody is being studied for its use in treating metastatic solid tumors with leptomeningeal disease. This medication is administered directly into the spinal fluid, a method known as intrathecal administration. The trial aims to determine the highest dose that can be given safely and to evaluate the safety of this treatment approach. The PD-1 antibody works by blocking a specific pathway that cancer cells use to avoid being attacked by the immune system, potentially allowing the body's natural defenses to better target and destroy cancer cells.

Nivolumab

What is already known about the treatment

PD-1 Antibody – This medication is administered intrathecally, meaning it is delivered directly into the spinal canal. It is currently being studied in clinical trials for its potential use in treating leptomeningeal disease, a condition associated with metastatic solid tumors. The main therapeutic indication is to manage and treat this specific type of cancer spread. At the molecular level, the PD-1 antibody works by blocking the PD-1 protein on immune cells, which can enhance the body's immune response against cancer cells. It is classified pharmacologically as an immune checkpoint inhibitor.

Investigated diseases

Leptomeningeal Disease – This condition involves the spread of cancer to the membranes surrounding the brain and spinal cord, known as the leptomeninges. It occurs when cancer cells infiltrate the cerebrospinal fluid, leading to inflammation and irritation of these protective layers. Symptoms can vary widely, including headaches, nausea, vomiting, and neurological deficits such as weakness or sensory changes. As the disease progresses, it can cause more severe neurological impairments, including difficulties with coordination, balance, and cognitive functions. The progression of symptoms often depends on the type and location of the primary cancer, as well as the extent of leptomeningeal involvement.