Study on Immunotherapy (Ipilimumab and Nivolumab) for Patients with Recurrent Glioma with High Mutation Levels
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04145115
This clinical trial is exploring the use of immunotherapy drugs, ipilimumab and nivolumab, to treat patients with glioma that has returned and has a high number of genetic mutations. The study aims to see if these drugs can help the immune system fight the cancer and prevent it from growing or spreading.
Patient Parameters
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Program Overview
This study is testing whether the combination of two immunotherapy drugs, ipilimumab and nivolumab, can help treat glioma that has come back and has a high number of mutations. Glioma is a type of brain cancer, and tumors with many mutations might respond well to immunotherapy. These drugs work by helping the immune system attack cancer cells and may stop the tumor from growing or spreading. The study compares this treatment to the usual care, which includes surgery or chemotherapy.
Description
The main goal of this study is to find out if using ipilimumab and nivolumab together can increase the rate at which tumors shrink in patients with recurrent glioblastoma that has many mutations. Researchers will also look at how long patients live, how long they live without the cancer getting worse, and what side effects they experience.
Patients will receive the drugs through an IV every three weeks for four cycles, as long as the cancer does not progress or cause unacceptable side effects. After that, they will receive nivolumab every four weeks. MRI scans will be used to monitor the cancer throughout the study.
After finishing the treatment, patients whose cancer has not progressed will be checked every eight weeks until it does, and then every three months for up to three years. Patients whose cancer progresses after treatment will be followed every three months for up to three years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with glioblastoma (a type of brain cancer) that has come back once or twice.
- The cancer must have a high number of mutations, as shown by specific tests.
- Have a measurable tumor on an MRI scan.
- Tissue sample from a recent surgery or biopsy must be available.
- Do not need more than 4 mg of dexamethasone (a steroid) after surgery.
- No active autoimmune diseases or history of such diseases, except for certain conditions like vitiligo or controlled thyroiditis.
- No previous treatment with certain immunotherapy drugs or bevacizumab.
- Age 18 or older.
- Able to have an MRI with contrast.
- Meet specific blood count and organ function requirements.
- No other active cancers that required treatment in the last two years, except for certain skin cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
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