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RecruitingNCT05465954

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
54 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy of pembrolizumab + efineptakin alfa (NT-I7) in combination with surgery in patients with recurrent glioblastoma multiforme (GBM) using the rate of overall survival at 9 months. SECONDARY OBJECTIVES: I. To assess progression-free survival in recurrent GBM patients treated with pembrolizumab + NT-I7 in combination with surgery. II. To determine the objective response rate in recurrent GBM patients treated with pembrolizumab + NT-I7 in combination with surgery. III. To assess changes in absolute lymphocyte counts (ALC) over time in recurrent GBM patients treated with pembrolizumab + NT-I7 in combination with surgery. TERTIARY OBJECTIVES: I. To assess the adverse event (AE) and toxicity profile of pembrolizumab + NT-I7 in combination with surgery in patients with recurrent GBM. II. To assess the anti-glioma immune response in patients with recurrent GBM, before and after pembrolizumab and NT-I7 treatment, including assessment of cytokine profiling, immune cell phenotyping, function, and activation in the pre/post-treatment blood and tumor tissue when available. III. To test tumor mutation burden on tumor/immune cells by validated comprehensive genomic profiling. IV. To evaluate the changes for tumor microenvironment (TME) post pembrolizumab and NT-I7 and their correlations with treatment response and survival. V. To evaluate tumor infiltrating lymphocytes (CD4, CD8, Treg, etc) in the tumor tissue pre- and post-treatment (when available). VI. To assess changes in repertoire breadth and clonality by T-cell receptor (TCR) sequencing. VII. To explore potential tissue and blood biomarkers that may predict response. OUTLINE: BEFORE SURGERY: Patients receive pembrolizumab intravenously (IV) over 30 minutes and efineptakin alfa intramuscularly (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 magnetic resonance imaging (MRI) or computed tomography (CT) at baseline and on study. Patients also undergo tumor biopsy at baseline and blood sample collection on study. After completion of study treatment, patients are followed up at 30 days and every 2-3 months until disease progression (if applicable), and then every 6 months for up to 5 years from study registration.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionCorrelative studies
BIOLOGICALEfineptakin alfaGiven IM
BIOLOGICALPembrolizumabGiven IV
PROCEDUREBiopsyUndergo tumor biopsy

Timeline

Start date
2023-01-24
Primary completion
2027-10-15
Completion
2028-10-15
First posted
2022-07-20
Last updated
2026-01-12

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05465954. Inclusion in this directory is not an endorsement.