Immunotherapy for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of two immunotherapy drugs, ipilimumab (Yervoy) and nivolumab (Opdivo), in treating recurrent gliomas with numerous genetic changes. These drugs may enhance the immune system's ability to combat cancer and prevent its growth or spread. Individuals with recurrent glioblastoma, characterized by a high number of mutations and no prior treatment with similar immunotherapies, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and ipilimumab has been tested in patients with melanoma, including those with brain metastases. The combination did not reveal any new safety concerns. However, about 55% of patients experienced serious side effects, with 7% having effects on the brain and nervous system. This indicates that some people had significant reactions, but these were mostly known or expected.
Although this information comes from studies on other types of cancer, the same combination is being tested for brain tumors in this trial. Knowing the trial phase is helpful. As a Phase 2 trial, there is already some safety information from earlier studies. However, monitoring how participants react in this specific trial remains important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ipilimumab and nivolumab for brain tumors because these treatments take a novel approach by harnessing the power of the immune system, unlike traditional therapies like surgery, radiation, or chemotherapy. Ipilimumab and nivolumab are immune checkpoint inhibitors that work by blocking proteins that prevent T-cells from attacking cancer cells, allowing the immune system to target the tumor more effectively. This mechanism offers a promising alternative to existing treatments, potentially leading to improved outcomes for patients with brain tumors.
What evidence suggests that this treatment might be an effective treatment for recurrent glioma?
Research has shown that using the immunotherapy drugs ipilimumab and nivolumab together can treat certain cancers more effectively. In this trial, participants will receive both ipilimumab and nivolumab. Studies have found that this combination improves patient response to treatment and increases survival rates, especially in those with cancer that has spread to the brain. For patients with melanoma and untreated brain cancer, this drug duo has remained effective for several years. This suggests it might also work for recurrent glioma, a type of brain tumor with many mutations. These drugs help the immune system attack and possibly stop these tumors from growing and spreading.56789
Who Is on the Research Team?
Gavin P Dunn
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
Adults (18+) with recurrent glioma, specifically high-grade glioblastomas or astrocytomas at first or second recurrence. Participants must have measurable disease on MRI and not be on high doses of steroids. No history of autoimmune diseases, no prior immunotherapy or bevacizumab, and should meet certain blood test criteria for organ function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab and ipilimumab intravenously. Treatment repeats every 3 weeks for 4 cycles, followed by nivolumab every 4 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 8 weeks until disease progression, then every 3 months for up to 3 years.
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor