GI-102 + Pembrolizumab for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to treating certain types of brain cancer, specifically glioblastoma and astrocytoma, which are aggressive tumors that have returned or are worsening. Researchers are exploring the effects of a new treatment called GI-102, both alone and with pembrolizumab, an immunotherapy that helps the immune system fight tumors. The goal is to determine if these treatments can shrink tumors and make them easier to remove surgically. People diagnosed with worsening or recurrent glioblastoma or astrocytoma, who are candidates for surgery, might be suitable for this trial. As a Phase 2 trial, this study measures how well the treatment works in an initial, smaller group of people, offering a chance to contribute to important research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have received certain treatments like bevacizumab, chemotherapy, or a live vaccine within 30 days before joining. If you're on dexamethasone, the dose must be 4 mg/day or less.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using GI-102 alone or with pembrolizumab might be safe and manageable for patients. Earlier studies have shown promise for these treatments in certain brain cancers. Although detailed information remains limited, the treatment has advanced to its current phase, indicating it has passed initial safety tests in humans. This progression suggests that any serious side effects can likely be managed.
Pembrolizumab has already received approval for other conditions, providing some confidence about its safety. However, individual experiences can vary, and side effects may still occur. For those considering joining the trial, this information may help in understanding the treatment's safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GI-102 combined with pembrolizumab for brain cancer because it introduces a novel approach compared to existing treatments like temozolomide and radiation therapy. GI-102 is an innovative compound that works alongside pembrolizumab, an immune checkpoint inhibitor, to potentially enhance the immune system's ability to target and destroy cancer cells. This combination could offer a more precise attack on brain tumors by leveraging the body's natural defenses, possibly leading to better outcomes and fewer side effects. Additionally, the use of pembrolizumab in this regimen is noteworthy for its established role in boosting immune responses against cancer, offering hope for improved effectiveness in treating brain cancer.
What evidence suggests that this trial's treatments could be effective for brain cancer?
Research suggests that GI-102, a special type of protein, could help the immune system target brain tumors by preventing tumor cells from growing and spreading. Pembrolizumab, a common cancer treatment, helps the body's immune system attack tumors. In this trial, participants will join different groups to receive these treatments. Group A will receive GI-102 initially, with the option to add pembrolizumab starting from cycle 2. Group B will receive both GI-102 and pembrolizumab from the beginning. Although specific data on using GI-102 and pembrolizumab for brain cancer is not yet available, similar combinations have shown promising results in other types of cancer. The researchers hope this combination will help treat glioblastoma and astrocytoma, which are aggressive brain tumors.12346
Who Is on the Research Team?
Jian L Campian, MD, PhD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Adults over 18 with recurrent or worsening IDH wildtype glioblastoma or IDH mutated grade 4 astrocytoma, who are candidates for surgery. They must have a performance status that allows daily activity and adequate blood counts. The trial is at Mayo Clinic in Rochester, MN.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GI-102 alone or in combination with pembrolizumab before surgery. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Surgery
Participants undergo surgery at least 14 days after cycle 1 day 1 treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including overall survival and incidence of adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- GI-102
- Pembrolizumab
Trial Overview
The trial compares GI-102 alone and combined with pembrolizumab before surgery to see if they can shrink brain tumors more effectively than current treatments. It tests whether these drugs can boost the immune system's ability to fight cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive GI-102 IV over 30-120 minutes and pembrolizumab IV over 30 minutes on day 1 of cycle 1. Patients undergo surgery at least 14 days after cycle 1 day 1 treatment. Patients then receive GI-102 IV over 30-120 minutes and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles 2+ repeat every 21 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients may receive GI-102 for up to 2 years. Patients also undergo echocardiography or MUGA at screening, as well as blood sample collection and MRI or CT throughout the study.
Patients receive GI-102 IV over 30-120 minutes on day 1 of cycle 1. Patients undergo surgery at least 14 days after cycle 1 day 1 treatment. Starting with cycle 2, patients may also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles 2+ repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may receive GI-102 for up to 2 years. Patients also undergo echocardiography or MUGA at screening, as well as blood sample collection and MRI or CT throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
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GI-102 + Pembrolizumab for Brain Cancer
The trial compares GI-102 alone and combined with pembrolizumab before surgery to see if they can shrink brain tumors more effectively than current treatments.
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The results were quite disappointing with an 8% response rate. In a subsequent phase II randomized study,34 pembrolizumab was evaluated with or ...
NCT05824975 | A Study to Evaluate the Safety and ...
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination ...
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