RecruitingPhase 2NCT05465954

Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma


Sponsor

Mayo Clinic

Enrollment

54 participants

Start Date

Jan 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — efineptakin alfa (a growth factor that helps brain cells survive) and pembrolizumab (an immunotherapy) — for people with recurrent glioblastoma, the most aggressive form of brain tumor, whose cancer has grown back after standard treatment. **You may be eligible if...** - You are 18 or older with recurrent or progressive glioblastoma (WHO Grade IV IDH wildtype) - You have previously received surgery, radiation, and temozolomide chemotherapy - Your tumor is visible on MRI and can be surgically removed again - Your overall health is adequate for treatment (ECOG 0–2) **You may NOT be eligible if...** - You have had prior immunotherapy for your brain tumor - You have active autoimmune disease or are on immunosuppressive steroids - You are pregnant or breastfeeding - Your tumor has certain molecular features (e.g., IDH mutation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Correlative studies

BIOLOGICALEfineptakin alfa

Given IM

BIOLOGICALPembrolizumab

Given IV

PROCEDUREBiopsy

Undergo tumor biopsy


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT05465954


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