GI-102 + Pembrolizumab for Brain Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Bevacizumab, Chemotherapy, Live vaccines, others

Disqualifiers: Pregnancy, Intracranial pressure, Autoimmune disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 23

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.

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

I am 18 years old or older.

My condition matches the specific disease traits required.

My brain tumor is a grade IV glioblastoma or astrocytoma without IDH mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

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.

Up to 2 years

Every 21 days (in-person)

Surgery

Participants undergo surgery at least 14 days after cycle 1 day 1 treatment.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and incidence of adverse events.

Up to 5 years

Regular visits (in-person and virtual)

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?

Group I: Group B (GI-102, pembrolizumab) Experimental Treatment 8 Interventions

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.

Group II: Group A (GI-102, pembrolizumab) Experimental Treatment 8 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+