Study on the Safety and Effectiveness of Nivolumab, Ipilimumab, and Myeloid Dendritic Cells for Patients with Recurrent Glioblastoma After Surgery

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What is this study about?

This clinical trial is focused on studying a type of brain cancer called glioblastoma. The study involves the use of two medications, ipilimumab and nivolumab, which are given to patients after the surgical removal of the tumor. Ipilimumab is administered directly into the tumor area, while nivolumab is given through an intravenous infusion, which means it is delivered into a vein. Additionally, the study will explore the use of a special cell therapy involving CD1c+/CD141+ myeloid dendritic cells, which are a type of immune cell taken from the patient’s own blood.

The purpose of the study is to assess the safety and anti-tumor activity of these treatments when used together. After the tumor is surgically removed, patients will receive an injection of ipilimumab directly into the tumor site, along with nivolumab. Following this, nivolumab will be administered both into the cavity left by the tumor and through the vein. The study will monitor how the body responds to these treatments and any side effects that may occur.

Participants in the study will undergo regular check-ups and tests to track their progress. The study aims to gather information on how well these treatments work together in fighting glioblastoma and to ensure they are safe for patients. The trial will continue until the end of 2026, with the goal of improving treatment options for those affected by this aggressive form of brain cancer.

1 initial treatment phase

The trial begins with the surgical removal of the recurrent glioblastoma tumor. This may involve a biopsy or a more extensive surgical procedure.

Following the surgery, a combination of medications is administered. This includes an injection of ipilimumab directly into the tumor site and an infusion of nivolumab through a vein.

2 medication administration

After the initial treatment, the patient receives further doses of nivolumab through intravenous infusion. This is combined with additional injections of ipilimumab into the cavity left by the tumor removal.

The frequency and dosage of these medications are determined by the trial protocol and may vary based on individual response and tolerance.

3 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment are closely monitored. This includes regular medical check-ups, imaging tests such as MRI, and laboratory tests to assess organ function and detect any side effects.

The primary goal is to ensure the safety of the treatment and to observe any anti-tumor effects.

4 completion and evaluation

The trial concludes with a final evaluation of the patient’s condition. This includes assessing the overall survival, progression-free survival, and any changes in the tumor size or characteristics.

The data collected during the trial is used to determine the safety and effectiveness of the treatment regimen.

Who Can Join the Study?

You must have signed a written consent form agreeing to participate in the study.
Your ECOG performance status score should be 0, 1, or 2. This score measures your ability to perform daily activities.
At least 4 months should have passed since your last radiation therapy for glioblastoma, unless a brain MRI shows tumor progression.
Your organs must be functioning well, as shown by specific blood tests.
You should not have been treated with nivolumab or ipilimumab before.
You should not have been treated with therapies targeting CTLA-4 or PD-1/-L1, which are proteins involved in immune response.
You should not have any digestive system issues that affect medication intake or absorption.
Your blood pressure should be controlled and within normal limits.
You should not be participating in another clinical trial or require ongoing blood-thinning medication.
You should not have an active autoimmune disease, except for certain conditions like type I diabetes or skin disorders that don’t need systemic treatment.
You should not be taking high doses of steroids or other immune-suppressing medications.
You must be 18 years of age or older.
You need to have good veins for a procedure called leukapheresis, which collects white blood cells.
You should not have uncontrolled seizures.
You should not have had a heart attack or serious heart issues in the past year.
You should not have HIV or AIDS-related illnesses.
You should not have any serious medical conditions or infections that would affect your ability to receive treatment.
You should not have had any other cancer, except for certain types treated successfully, with no signs of disease for 5 years.
You should not have any severe medical or psychiatric conditions that would make participating in the study risky or inappropriate.
You should not have dementia or mental issues that would prevent you from understanding the study requirements.
Women who can have children must have a negative pregnancy test and agree to use effective birth control during the study. Men must also agree to use effective birth control.
If participating in Cohort 5, you should not have any issues preventing brain surgery for glioblastoma recurrence.
Any side effects from previous treatments should be mild or resolved, except for hair loss.
If participating in Cohort 6, the recurrent tumor should be suitable for a safe biopsy, and there should be a resection cavity from previous surgery.
You must be willing to follow the study schedule, including visits, tests, and procedures.
You must have a confirmed diagnosis of glioblastoma, which is a type of brain tumor.
Your glioblastoma should have returned or progressed after previous treatments, including surgery, radiation, and chemotherapy.
Your tumor should be measurable on an MRI scan, with no significant bleeding inside the tumor.
You should not have a ventriculo-peritoneal drain, which is a tube used to relieve pressure in the brain.
You should not have any issues that prevent you from having certain types of brain scans.

Who Cannot Join the Study?

Patients who are not diagnosed with glioblastoma, which is a type of brain tumor.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria required for the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	03.11.2016

Trial locations

Investigated drugs:

Ipilimumab is a medication used in this trial to help the immune system attack cancer cells. It is administered directly into the tumor to enhance the body’s immune response against the cancer.

Nivolumab is another medication used in the trial, which is given both directly into the tumor and through a vein. It works by helping the immune system recognize and destroy cancer cells more effectively.

Autologous CD1c(BDCA-1)+/CD141(BDCA-3)+ myDC refers to a type of immune cell therapy used in the trial. These are special immune cells taken from the patient’s own body, modified, and then injected back into the patient to help stimulate a stronger immune response against the tumor.

Investigated diseases:

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often infiltrating surrounding brain tissue. Symptoms can vary depending on the tumor’s location but may include headaches, seizures, and changes in personality or cognitive function. As the disease progresses, these symptoms typically worsen, and new neurological deficits may develop. Glioblastoma is characterized by its tendency to recur even after treatment, making it a challenging condition to manage.

Trial ID:

2024-517842-33-01

NCT ID:

NCT03233152

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Nivolumab, Ipilimumab, and Myeloid Dendritic Cells for Patients with Recurrent Glioblastoma After Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?