Actively Recruiting
Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma
Led by Mayo Clinic · Updated on 2026-01-12
54
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
NeoImmuneTech
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.
CONDITIONS
Official Title
Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma
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 gliosarcoma
- Previously treated with maximum feasible surgery or biopsy, radiation, and temozolomide
- Presence of an enhancing tumor mass on MRI suitable for resection or biopsy
- Willingness to undergo biopsy and/or tumor resection at Mayo Clinic in Rochester, Minnesota
- ECOG performance status of 0 or 1 and Karnofsky Performance Scale score of 70 or higher
- Hemoglobin level of 9.0 g/dL or higher without recent transfusion or erythropoietin dependence
- Absolute neutrophil count of 1500/mm3 or higher
- Platelet count of 100,000/mm3 or higher
- Creatinine level less than or equal to 1.5 times the upper limit of normal or creatinine clearance at least 45 ml/min
- Total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin normal if total bilirubin is elevated
- AST and ALT less than or equal to 2.5 times upper limit of normal
- Coagulation tests (PT/INR/aPTT) less than or equal to 1.5 times upper limit of normal or within therapy target range if on anticoagulants
- Negative pregnancy test within 7 days before registration for persons of childbearing potential
- Willingness to use adequate contraception from first dose through 180 days after last dose for persons of childbearing potential or able to father a child
- Provide written informed consent
- Willingness to return to study site for follow-up during active monitoring
- Willingness to provide tissue and blood samples for research
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child unwilling to use adequate contraception
- Signs or symptoms of life-threatening raised intracranial pressure requiring immediate surgery
- Received bevacizumab within 4 months prior to registration (allowed during adjuvant phase for symptoms)
- Received live vaccine within 30 days prior to registration
- Requirement for dexamethasone dose greater than 2 mg/day within 2 days prior to registration
- Not recovered from adverse events related to major surgery within 28 days or radiation within 14 days prior to registration
- Severe systemic illnesses or other diseases that interfere with safety assessment
- Known HIV infection
- Uncontrolled infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Receiving other investigational agents
- Active malignancy requiring systemic treatment within 1 year prior to registration
- History of myocardial infarction within 6 months or life-threatening heart arrhythmias requiring ongoing therapy
- Active autoimmune disease requiring systemic treatment within 2 years (replacement therapies excluded)
- Known active Hepatitis B and C infections unless meeting specific treatment and viral load criteria
- Known active tuberculosis
- History or current pneumonitis or interstitial lung disease requiring steroids
- Hypersensitivity to pembrolizumab or its components
- Received anti-PD-1/PD-L1/PD-L2 therapy within 12 months prior to registration
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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