Actively Recruiting
GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of 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
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 disease per Response Assessment in Neuro-Oncology 2.0
- Willing to undergo biopsy and tumor resection at Mayo Clinic in Rochester, Minnesota
- Eastern Cooperative Oncology Group performance status 0, 1, or 2 and Karnofsky performance status 60 or higher
- 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 less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 45 ml/min within 15 days before registration
- Total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin normal if total bilirubin is higher within 15 days before registration
- AST and ALT less than or equal to 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 for those who can become pregnant
- Willing to use contraception from first dose through 180 days after last dose if able to have children
- 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 to the enrolling institution for follow-up during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons, or those of childbearing potential or able to father a child unwilling to use contraception
- Signs or symptoms of life-threatening raised intracranial pressure requiring immediate surgery
- Treatment with bevacizumab less than 30 days before registration (allowed during adjuvant phase for symptom control)
- Increasing dose of dexamethasone prior to registration (must be 4 mg/day or less at registration)
- Chemotherapy less than 30 days before registration
- Live vaccine less than 30 days before registration
- Not recovered from adverse events from major surgery less than 28 days prior or radiation therapy less than 14 days prior to registration
- Severe systemic illnesses or other diseases interfering with safety or study assessment
- Uncontrolled infections requiring IV antibiotics, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social illness limiting compliance
- Receiving other investigational agents at registration
- History of myocardial infarction within 6 months or severe heart failure with life-threatening arrhythmias
- Active autoimmune disease requiring systemic treatment within 2 years prior to registration
- Active hepatitis B and hepatitis C infections (exceptions with antiviral treatment and undetectable viral load apply)
- Known active tuberculosis
- History or current pneumonitis or interstitial lung disease requiring steroids
- Hypersensitivity to pembrolizumab, IL-2, GI-102, or components
- History of allogeneic tissue or solid organ transplant
AI-Screening
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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
CONTACT
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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