Actively Recruiting
GI-102 Alone or With Pembrolizumab Before Surgery for Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
Led by Mayo Clinic · Updated on 2026-04-08
36
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for adults with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma, which are aggressive brain tumors. This phase II trial compares GI-102 alone and in combination with pembrolizumab given before surgery. GI-102 is a bispecific fusion protein that may affect the immune system and tumor growth, while pembrolizumab is an immunotherapy that may help the immune system attack tumor cells. The study aims to assess safety, tolerance, and effects of these treatments given between neoadjuvant therapy and surgery. Participants receive GI-102 by intravenous infusion on day 1 of cycle 1, followed by surgery at least 14 days later. In one group, patients receive only GI-102 before surgery, and in the other group, they receive both GI-102 and pembrolizumab intravenously on day 1 of cycle 1. After surgery, patients may continue treatment with GI-102 alone or combined with pembrolizumab every 21 days for up to 2 years if their disease does not progress or they tolerate treatment. The study also includes echocardiography or MUGA scans at screening and regular blood tests, MRI or CT scans throughout the study. During the trial, participants undergo surgery and various tests including heart function scans, blood sample collection, and imaging studies to monitor tumor status. Researchers will measure changes in tumor tissue markers for up to 2 years and track overall survival for up to 5 years. Safety is assessed by recording adverse events for about 90 days after the last dose. Participants must return for follow-up visits during the active monitoring phase. The total participation duration can extend up to several years depending on treatment continuation and follow-up.
CONDITIONS
Brief Title
GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Tissue-confirmed progressive or recurrent WHO grade IV IDH wildtype glioblastoma or IDH mutated WHO grade 4 astrocytoma
- Candidates for surgical tumor removal
- Measurable or non-measurable tumor as defined by RANO 2.0 criteria
- Willing to undergo biopsy and tumor resection at Mayo Clinic
- ECOG performance status 0, 1, or 2 and Karnofsky performance status 60 or higher, assessed within 7 days before first treatment
- Hemoglobin 9.0 g/dL or higher within 15 days before registration
- Absolute neutrophil count 1500/mm3 or higher within 15 days before registration
- Platelet count 100,000/mm3 or higher within 15 days before registration
- Creatinine no higher than 1.5 times upper limit of normal or creatinine clearance at least 45 ml/min within 15 days before registration
- Total bilirubin no higher than 1.5 times upper limit of normal or direct bilirubin within normal limits within 15 days before registration
- AST and ALT no higher than 2.5 times upper limit of normal within 15 days before registration
- Amylase and lipase within normal limits within 15 days before registration
- Left ventricular ejection fraction 50% or higher within 29 days before registration
- Negative pregnancy test within 8 days before registration, if applicable
- Persons of childbearing potential willing to use contraception from first dose through 180 days after last dose
- Provide written informed consent
- Willing to provide blood and tissue samples for research
- Willing to consent to neuro-oncology biorepository for archiving samples
- Willing to return for follow-up visits during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons, or persons unwilling to use contraception
- Signs or symptoms of life-threatening raised intracranial pressure needing immediate surgery
- Received bevacizumab within 30 days before registration (allowed later for symptom control)
- Increasing dexamethasone dose before registration; dexamethasone dose must be 4 mg/day or less at registration
- Received chemotherapy or live vaccine within 30 days before registration
- Not recovered from major surgery within 28 days or radiation therapy within 14 days before registration
- Severe co-existing illnesses or uncontrolled infections or heart conditions
- Receiving other investigational agents at registration
- Recent myocardial infarction or life-threatening heart arrhythmias
- Active autoimmune disease requiring systemic treatment within 2 years
- Active hepatitis B and hepatitis C infections not properly controlled
- History of active tuberculosis
- History or current pneumonitis or interstitial lung disease requiring steroids
- Allergy to pembrolizumab, IL-2, GI-102, or their components
- History of allogeneic tissue or organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including echocardiography or MUGA and blood sample collection
Duration - Up to 2 years
Participants receive IV infusions of GI-102 alone or with pembrolizumab before undergoing surgery. Treatment cycles repeat every 21 days depending on the group assignment and continue up to 2 years in the absence of disease progression or unacceptable toxicity.
Infusions on day 1 of each 21-day cycle; surgery at least 14 days after first treatment; ongoing blood sample collections and imaging scans (MRI or CT) throughout treatment
Duration - At least 14 days after first treatment
Participants undergo surgical tumor removal following initial treatment.
1 surgical procedure visit
Duration - Up to 5 years
Participants are monitored for safety and overall survival after completing treatment.
Periodic follow-up visits for safety assessments and survival monitoring
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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