Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma
NCT05465954 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-01-12
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.
Conditions
- High Grade Astrocytic Tumor
- Recurrent Glioblastoma, IDH-Wildtype
- Recurrent Gliosarcoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Correlative studies
- BIOLOGICAL
-
Efineptakin alfa
Given IM
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Biopsy
Undergo tumor biopsy
Sponsors & Collaborators
-
NeoImmuneTech
collaborator INDUSTRY - collaborator INDUSTRY
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Jian L. Campian, MD, PhD · Mayo Clinic in Rochester
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-24
- Primary Completion
- 2027-10-15
- Completion
- 2028-10-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma
NCT06160206 ·Status: RECRUITING ·Phase: PHASE2
-
Pembrolizumab, Olaparib, and Temozolomide for People With Glioma
NCT05188508 ·Status: RECRUITING ·Phase: PHASE2
-
Pembrolizumab +/- Bevacizumab for Recurrent GBM
NCT02337491 ·Status: COMPLETED ·Phase: PHASE2
-
Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma
NCT02530502 ·Status: TERMINATED ·Phase: PHASE1
-
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
NCT03661723 ·Status: COMPLETED ·Phase: PHASE2
-
Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients
NCT05638451 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
NCT04485949 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
AB154 Combined With AB122 for Recurrent Glioblastoma
NCT04656535 ·Status: ACTIVE_NOT_RECRUITING ·Phase: EARLY_PHASE1
-
T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
NCT06157541 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
NCT05039281 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma
NCT03707457 ·Status: TERMINATED ·Phase: PHASE1
-
Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNA-level-relapse and Clinical-relapse Glioblastoma
NCT05502991 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
NCT06061809 ·Status: RECRUITING ·Phase: PHASE2
-
Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
NCT02052648 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
NCT07027748 ·Status: RECRUITING ·Phase: PHASE1
-
Repeat Radiation, Minocycline and Bevacizumab in Patients With Recurrent Glioma
NCT01580969 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)
NCT03491683 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Neoadjuvant Nivolumab in Glioblastoma
NCT02550249 ·Status: COMPLETED ·Phase: PHASE2
-
Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM
NCT00597493 ·Status: COMPLETED ·Phase: PHASE2
-
Abemaciclib + Pembrolizumab In Glioblastoma
NCT04118036 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas
NCT00921167 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence
NCT04013672 ·Status: COMPLETED ·Phase: PHASE2
-
Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas
NCT03532295 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
NCT00458601 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Study of Monoclonal Antibondy (GS) 5745, an Matix Metalloproteinase 9 (MMP9) Mab Inhibitor, in Combination With Bevacizumab in Patients With Recurrent Glioblastoma
NCT03631836 ·Status: UNKNOWN ·Phase: PHASE1