Clinical trial 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 GI-102?
This is an investigational medicine being studied as a potential treatment for recurrent or progressive glioblastoma. It is designed to help the body's immune system recognize and attack tumor cells.
Also referred to as GI 102, GI102.
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 study is testing whether GI-102 alone or with pembrolizumab helps shrink tumors. It also checks if these treatments are safe before surgery.
- Who it's for
- You may be able to join if you have a specific type of brain tumor that has come back or is growing.
- What's involved
- You would get GI-102 or both drugs before your surgery. The team will watch how your body reacts to the treatments.
- Time commitment
- The study lasts until after your surgery and follow-up visits.
- 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
- 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
- Received bevacizumab (AVASTIN) \< 30 days prior to registration
See the full eligibility criteria
- 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)
- 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
- NOTE: No washout is needed for prior immunotherapy
- 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...
- 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]...
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.