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New treatment option for High Grade Astrocytic Tumor
Official title Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT05465954
What this study is testing
What is Efineptakin alfa?
Efineptakin alfa is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high grade astrocytic tumor.
Also referred to as GX-I7, Hyleukin-7 (TM).
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 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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...
- Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide
- Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon...
You likely can't join if
- Any of the following because this study involves an investigational agent for which genotoxic, mutagenic, and teratogenic effects on the developing...
- 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)
- Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide
- Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy...
- Willing to undergo clinically indicated biopsy and/or resection of their glioblastoma at Mayo Clinic in Rochester, Minnesota (MN).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and Karnofsky Performance Scale (KPS) \>= 70 NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug
- Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration) (without transfusion or erythropoietin [EPO] dependency =\< 7 days prior to assessment)
- 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 =\ = 45 ml/min (obtained =\< 15 days prior to registration)
- Total bilirubin =\ 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)
- Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy...
- Negative pregnancy test done =\ 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.
- 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
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
- Willing to provide tissue and blood samples for correlative research purposes
What rules you out
- Any of the following because this study involves an investigational agent for which genotoxic, mutagenic, and teratogenic effects 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) =\< 4 months prior to registration
- Note: Bevacizumab is allowed for symptom control during the adjuvant phase of the study
- Received a live vaccine =\< 30 days prior to registration.
- Requirement for dexamethasone dose of \> 2mg/day =\< 2 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...
- Known history of human immunodeficiency virus (HIV) infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Receiving any other investigational agent
- Other active malignancy requiring systemic treatment =\< 1 year prior to registration
- History of myocardial infarction =\< 6 months prior to registration, 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...
- 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: 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...
- 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 or any of its excipients
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within \< 12 months prior to registration
- NOTE: If such therapy was given ≥ 12 months prior to registration, patient is eligible
- History of allogenic 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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.