NCT05465954

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
30mo left

Started Jan 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jan 2023Oct 2028

First Submitted

Initial submission to the registry

July 18, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2028

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

July 18, 2022

Last Update Submit

January 9, 2026

Conditions

High Grade Astrocytic TumorRecurrent Glioblastoma, IDH-WildtypeRecurrent Gliosarcoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    9-month overall survival rate (OS9) rate is defined as the number of "successes" (patients who are alive at least 9 months after beginning study therapy) divided by the total evaluable patients. All patients who have signed a consent form, are eligible, and have begun treatment in Cycle 1 (first cycle of neo-adjuvant pembrolizumab + efineptakin alfa \[NT-I7\]) will be considered evaluable for the primary endpoint.

    Up to 9 months

Secondary Outcomes (4)

  • Progression free survival time

    From the date of starting study treatment to the date of disease progression or death resulting from any cause, whichever comes first, assessed up to 5 years

  • Objective response rate (ORR)

    Up to 5 years

  • Changes in absolute lymphocyte counts (ALC)

    From baseline up to 12 weeks

  • Incidence of adverse events

    Up to 5 years

Study Arms (1)

Treatment (efineptakin alfa, pembrolizumab)

EXPERIMENTAL

BEFORE SURGERY: Patients receive pembrolizumab IV over 30 minutes and efineptakin alfa IM on day 1. Patients then undergo surgery 1 week later. AFTER SURGERY: Patients receive pembrolizumab IV over 30 minutes and efineptakin alfa IM on day 1 of each cycle. Cycles repeat every 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI or CT at baseline and on study. Patients also undergo tumor biopsy at baseline and blood sample collection on study.

Procedure: Biospecimen CollectionBiological: Efineptakin alfaBiological: PembrolizumabProcedure: Biopsy

Interventions

Biospecimen CollectionPROCEDURE

Correlative studies

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Treatment (efineptakin alfa, pembrolizumab)
Efineptakin alfaBIOLOGICAL

Given IM

Also known as: GX-I7, Hyleukin-7 (TM), Il-7 Hybrid Fc, IL-7-hyFc, NT-I7, rhIL-7-hyFc, TJ 107, TJ-107, TJ107
Treatment (efineptakin alfa, pembrolizumab)
PembrolizumabBIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Treatment (efineptakin alfa, pembrolizumab)
BiopsyPROCEDURE

Undergo tumor biopsy

Also known as: BIOPSY_TYPE, Bx
Treatment (efineptakin alfa, pembrolizumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 or surgery
  • 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 =\< 1.5 x upper limits 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)
  • 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 (obtained =\< 15 days prior to registration)
  • Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only (POCBP) Note: If testing done for eligibility is \> 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.
  • +4 more criteria

You may not qualify if:

  • 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 scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait).
  • 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 assessment of safety and toxicity of the prescribed regimens
  • Known history of human immunodeficiency virus (HIV) infection
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

GlioblastomaGliosarcoma

Interventions

Specimen Handlingefineptakin alfagosha-jinki-ganpembrolizumabBiopsy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • Jian L. Campian, MD, PhD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 20, 2022

Study Start

January 24, 2023

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2028

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(1)