Study on Immune Response to Treatment with Immune Checkpoint Inhibitors in Patients with Newly Diagnosed Glioblastoma or Gliosarcoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04817254
This clinical trial is exploring how the immune system responds to a combination of drugs, including ipilimumab and nivolumab, in patients with newly diagnosed glioblastoma or gliosarcoma. The study aims to understand changes in immune cells in the blood and how these changes relate to treatment outcomes.
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Program Overview
Glioblastoma and gliosarcoma are aggressive brain cancers that are difficult to treat. This study focuses on patients who have recently been diagnosed and have completed surgery, chemotherapy, and radiation. Researchers are investigating how the immune system responds to a combination of drugs, including ipilimumab and nivolumab, along with temozolomide. The goal is to see if these treatments can improve survival by boosting the immune response in the blood.
Description
Glioblastoma is a challenging cancer with limited treatment options. This study is testing whether drugs that help the immune system, called immune checkpoint inhibitors, can improve outcomes for patients with newly diagnosed glioblastoma or gliosarcoma. The study will look at how immune cells in the blood respond to these treatments and whether this response can predict how well the treatment works.
Participants will be randomly assigned to one of two treatment groups. Both groups will receive temozolomide, a chemotherapy drug, and a combination of immune checkpoint inhibitors, nivolumab and ipilimumab. The study will monitor changes in immune cells in the blood to understand the body's response to the treatment.
The study will also explore how well the immune cells respond to stimulation in the lab before and after treatment. This will help researchers understand if the lab tests can predict how the immune system will respond in the body.
Additional studies will look at the immune response to the combination of chemotherapy and immunotherapy, including how certain immune cells react to specific stimulations.
Eligibility Criteria
Inclusion Criteria
- Must have a new diagnosis of glioblastoma or gliosarcoma confirmed by lab tests.
- Must have had surgery to remove the tumor and completed initial chemotherapy and radiation.
- Must be 18 years or older.
- Must have a good level of daily functioning, with a Karnofsky score of 70% or higher.
- Must have good organ and bone marrow function, as shown by specific blood tests.
- Must agree to use effective birth control during the study and for six months after treatment.
- Must be able to understand and sign a consent form agreeing to participate in the study.
Exclusion Criteria
- Evidence of cancer progression based on clinical or imaging tests.
- Previous treatment with certain local therapies like Gliadel wafers or brachytherapy.
- Currently receiving other experimental treatments.
- History of receiving immune therapies like vaccines or certain drug deliveries.
- Allergic reactions to similar drugs used in the study.
- History of severe allergic reactions to contrast dyes used in imaging tests.
- History of autoimmune diseases that could worsen with treatment.
- Currently taking high doses of steroids or other immune-suppressing drugs.
- Uncontrolled health conditions that could interfere with the study.
- Pregnant or breastfeeding women due to unknown risks to the baby.
- History of hepatitis infection.
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