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New treatment option for Glioblastoma, IDH-Wildtype
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
ClinicalTrials.gov ID: NCT07301268
What this study is testing
What is Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102?
Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma, idh-wildtype.
Also referred to as GI 102, GI-102.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Disease characteristics
- Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and...
- Candidates for surgical resection
- Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0
You likely can't join if
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the...
- 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...
- Prior treatment
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- 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)
What rules you out
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
- 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...
- 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...
- 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]...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.