Actively Recruiting
Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma
Led by Mayo Clinic · Updated on 2026-01-12
54
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
NeoImmuneTech
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and side effects of combining efineptakin alfa and pembrolizumab with surgery in patients who have recurrent glioblastoma, a type of aggressive brain tumor. This phase II trial aims to determine the overall survival rate at 9 months and assess progression-free survival, objective response rate, immune changes, and adverse events. The study also explores how the treatment affects the tumor environment and immune system, including tumor mutation burden and T-cell activity. Patients receive pembrolizumab through an intravenous infusion and efineptakin alfa via intramuscular injection before surgery. One week later, patients undergo surgery to remove or biopsy the tumor. After surgery, patients continue to receive pembrolizumab and efineptakin alfa every 42 days for up to two years, as long as the disease does not progress and side effects are acceptable. Imaging scans like MRI or CT and tumor biopsies are done at baseline and during the study to monitor disease and treatment effects. Participants will have blood samples collected periodically to evaluate immune responses and biomarkers. They are followed for safety, treatment response, and disease progression with visits 30 days after treatment ends, every 2 to 3 months during active monitoring, and then every 6 months for up to 5 years. The main measure of success is survival at 9 months, with ongoing assessments of tumor response, immune system changes, and side effects throughout the study period.
CONDITIONS
Brief 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 resection or biopsy, radiation, and temozolomide
- Enhancing tumor mass visible on MRI suitable for resection or biopsy
- Willing to undergo biopsy and/or tumor resection at Mayo Clinic, Minnesota
- ECOG Performance Status of 0 or 1 and Karnofsky Performance Scale 70 or higher
- Hemoglobin 9.0 g/dL or higher without recent transfusion or EPO dependency
- Absolute neutrophil count 1500/mm3 or higher
- Platelet count 100,000/mm3 or higher
- Creatinine within 1.5 times upper limit of normal or creatinine clearance 45 ml/min or higher
- Total bilirubin 1.5 times upper limit of normal or less, or direct bilirubin normal if total bilirubin above 1.5 times upper limit
- AST and ALT 2.5 times upper limit of normal or less
- Coagulation tests (PT/INR/aPTT) within 1.5 times upper limit, or within therapeutic range if on anticoagulants
- Negative pregnancy test within 7 days for persons of childbearing potential
- Willing to use contraception during treatment and for 180 days after last dose if able to have children
- Provide written informed consent
- Willing to return for follow-up during active monitoring
- Willing 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 contraception
- Signs or symptoms of life-threatening raised intracranial pressure requiring immediate surgery
- Received bevacizumab within 4 months prior to registration (except during adjuvant phase for symptom control)
- Received live vaccine within 30 days prior to registration
- Required dexamethasone dose over 2 mg/day within 2 days before registration
- Not recovered from major surgery within 28 days or radiation therapy within 14 days before registration
- Severe concurrent illness or conditions affecting safety or assessment
- Known HIV infection
- Uncontrolled infections, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting compliance
- Receiving other investigational agents
- Active cancer requiring systemic treatment within 1 year prior to registration
- Recent myocardial infarction or life-threatening arrhythmias
- Active autoimmune disease requiring systemic treatment within 2 years
- Active hepatitis B and C infections not meeting specific criteria
- History of active tuberculosis
- History or current pneumonitis or interstitial lung disease requiring steroids
- Allergy to pembrolizumab or its components
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents within 12 months
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive pembrolizumab intravenously and efineptakin alfa intramuscularly before surgery. Surgery occurs 1 week later. After surgery, participants continue treatment with pembrolizumab IV and efineptakin alfa IM on day 1 of each 42-day cycle for up to 2 years, unless disease progresses or unacceptable toxicity occurs.
Cycles repeat every 42 days
Duration - Up to 5 years
After completing treatment, participants are followed up at 30 days and then every 2-3 months until disease progression, followed by visits every 6 months for up to 5 years from study registration.
Follow-up visits every 2-3 months, then every 6 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
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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