At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Tissue-confirmed progressive or recurrent WHO Grade IV IDH wildtype glioblastoma including molecular glioblastoma and gliosarcoma
- ✓Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide
- ✓Enhancing mass on MRI amenable to resection or biopsy with histological diagnosis of glioblastoma from prior biopsy or surgery
- ✕Pregnant or nursing persons
- ✕Persons of childbearing potential unwilling to employ adequate contraception
- ✕Signs or symptoms of life-threatening raised intracranial pressure precluding 4-7-day delay in neurosurgery
- ✕Bevacizumab within ≤4 months prior to registration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma
In Brief
A Phase 2 clinical trial evaluating Biospecimen Collection, Efineptakin alfa, and 2 other interventions for High Grade Astrocytic Tumor and 2 related conditions. Currently recruiting, targeting 54 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Correlative studies
Given IM
Given IV
Undergo tumor biopsy