GI-102 Alone or in Combination With Pembrolizumab Before Surgery for the Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
NCT ID: NCT07301268
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2025-12-29
2034-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A (GI-102, pembrolizumab)
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.
Biospecimen Collection
Undergo blood sample collection
Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102
Given IV
Computed Tomography
Undergo CT
Echocardiography Test
Undergo echocardiography
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Pembrolizumab
Given IV
Surgical Procedure
Undergo surgery
Group B (GI-102, pembrolizumab)
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.
Biospecimen Collection
Undergo blood sample collection
Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102
Given IV
Computed Tomography
Undergo CT
Echocardiography Test
Undergo echocardiography
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Pembrolizumab
Given IV
Surgical Procedure
Undergo surgery
Interventions
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Biospecimen Collection
Undergo blood sample collection
Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102
Given IV
Computed Tomography
Undergo CT
Echocardiography Test
Undergo echocardiography
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Pembrolizumab
Given IV
Surgical Procedure
Undergo surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease characteristics
* Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma
* Candidates for surgical resection
* Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0
* Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60
* NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug
* Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
* Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
* Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min (obtained ≤ 15 days prior to registration)
* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 x ULN (obtained ≤ 15 days prior to registration)
* Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)
* Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)
* Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)
* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
* Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose
* Provide written informed consent
* Willingness to provide blood specimens for correlative research
* Willingness to provide tissue specimens for correlative research
* Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and/or blood samples collected on this protocol
* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion Criteria
* Pregnant persons
* Nursing persons
* Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)
* Prior treatment
* Received bevacizumab (AVASTIN) \< 30 days prior to registration
* NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study
* Increasing dexamethasone dose prior to registration
* NOTE: Patients currently on dexamethasone must be on dose ≤ 4 mg/day at time of registration
* Received chemotherapy \< 30 days prior to registration
* Received a live vaccine \< 30 days prior to registration
* Failure to recover from any adverse events related to any of the following therapies received prior to registration:
* Major surgery \< 28 days prior to registration
* Radiation therapy \< 14 days prior to registration
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection requiring IV antibiotics
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Or psychiatric illness/social situations (e.g., drug addiction) that would limit compliance with study requirements
* Receiving any other investigational agent at the time of registration
* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration
* NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
* Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] detected by polymerase chain reaction \[PCR\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority
* NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:
* Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment
* Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration
* Known history of active TB (Bacillus tuberculosis)
* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease
* Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients
* History of allogeneic tissue/solid organ transplant
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Jian L Campian, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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MC230719
Identifier Type: -
Identifier Source: org_study_id
NCI-2025-09081
Identifier Type: REGISTRY
Identifier Source: secondary_id
25-002007
Identifier Type: OTHER
Identifier Source: secondary_id
MC230719
Identifier Type: OTHER
Identifier Source: secondary_id