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Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

ConditionsHigh Grade Astrocytic TumorRecurrent Glioblastoma, IDH-WildtypeRecurrent Gliosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Correlative studies

  • Efineptakin alfa

    Biological/Vaccine

    Given IM

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Biopsy

    Procedure/Surgery

    Undergo tumor biopsy

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Treatment (efineptakin alfa, pembrolizumab)Experimental treatment 4 interventions

Trial outcomes

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.

Time frame
Up to 9 months

Secondary outcomes

1

Progression free survival time

Progression is defined according to Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria. The median and 95% confidence intervals will be estimated using the Kaplan-Meier estimator.

Time frame
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
2

Objective response rate (ORR)

Objective response rate (ORR) is defined as the number of responses achieved during treatment with pembrolizumab + NT-I7 in combination with surgery divided by the total number of evaluable patients. A patient will be deemed to have a response if complete response (CR) or partial response (PR) is achieved. Only patients with measurable disease documented on the post-operative baseline scan (prior to initiation of Cycle 2) will be considered evaluable for ORR. Point estimates will be generated for response rate with corresponding 95% binomial confidence intervals (Duffy and Santner).

Time frame
Up to 5 years
3

Changes in absolute lymphocyte counts (ALC)

Point estimates will be generated for the difference (at the magnitude of a fold-change) with corresponding 95% confidence intervals. All other changes in ALC over time will be exploratory and hypothesis generating. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

Time frame
From baseline up to 12 weeks
4

Incidence of adverse events

The number and severity of all adverse events will be tabulated and summarized in this patient population. Specifically, the overall percentages for Grade 3 or higher adverse events considered at least possibly related to treatment will also be calculated and reported. All other adverse event analysis will be exploratory and hypothesis generating. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

NeoImmuneTech

Collaborator

Merck Sharp & Dohme LLC

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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