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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
12.10.2021

Trial locations

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.

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.

Trial ID:
2024-514068-14-00
Protocol code:
IT-PD1
NCT ID:
NCT05112549
Trial Phase:
Human Pharmacology (Phase I) – Other

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