TABLE 2.
Clinical trials in glioblastoma (GBM) using immune checkpoint inhibitors (ICIs).
| Title | Condition or Disease | Intervention/Treatment | NCT Number | Status | Status Phase |
| Neoantigen-based personalized vaccine combined with immune checkpoint blockade therapy in patients with newly diagnosed, unmethylated glioblastoma | Glioblastoma | Biological: NeoVax Biological: Nivolumab Biological: Ipilimumab | NCT03422094 | Suspended | Phase I |
| Autologous dendritic cells, metronomic cyclophosphamide and checkpoint blockade in children with relapsed HGG | Childhood glioblastoma | Drug: depletion of regulatory T cells Biological: cancer vaccine Biological: checkpoint blockade | NCT03879512 | Recluting | Phase I, II |
| Cytokine microdialysis for real-time immune monitoring in glioblastoma patients undergoing checkpoint blockade | Glioblastoma | Drug: Nivolumab Drug: BMS-986016 | NCT03493932 | Recluting | Phase I |
| Laser interstitial thermotherapy (LITT) combined with checkpoint inhibitor for recurrent GBM (RGBM) | Glioblastoma Adult | Drug: Pembrolizumab at 7 days prior Drug: Pembrolizumab at 14 days post Drug: Pembrolizumab at 35 days post | NCT03277638 | Recluting | Phase I, II |
| Pilot surgical trial to evaluate early immunologic pharmacodynamic parameters for the PD-1 checkpoint inhibitor, pembrolizumab (MK-3475), In patients with surgically accessible recurrent/progressive glioblastoma | Brain cancer | Drug: MK-3475 | NCT02852655 | Active, not recruiting | Phase I |
| A study testing the effect of immunotherapy (ipilimumab and nivolumab) in patients with recurrent glioblastoma with elevated mutational burden | Recurrent glioblastoma Secondary glioblastoma | Biological: Ipilimumab Biological: Nivolumab | NCT04145115 | Not yet recruiting | Phase II |
| First-in-human, phase 1b/2a trial of a multipeptide therapeutic vaccine in patients with progressive glioblastoma | Glioblastoma Adult | Biological: Multiple dose of EO2401 | NCT04116658 | Not yet recruiting | Phase I, II |
| A phase 1 study of PVSRIPO and pembrolizumab in patients with recurrent glioblastoma | Glioblastoma Recurrent glioblastoma Supratentorial glioblastoma Brain tumor | Biological: PVSRIPO Biological: Pembrolizumab | NCT04479241 | Not yet recruiting | Phase I |
| Nivolumab, BMS-986205, and radiation therapy with or without temozolomide in treating patients with newly diagnosed glioblastoma | Glioblastoma | Biological: IDO1 Inhibitor BMS-986205 Biological: Nivolumab Drug: Temozolomide | NCT04047706 | Recluting | Phase I |
| Immunogene-modified T (IgT) cells against glioblastoma multiforme | Glioblastoma multiforme of brain Glioblastoma multiforme | Biological: Antigenspecific IgT cells | NCT03170141 | Enrolling by invitation | Phase I |
| An investigational immunotherapy study of nivolumab compared to temozolomide, each given with radiation therapy, for newly diagnosed patients with glioblastoma (GBM, a malignant brain cancer) | Brain Cancer | Drug: Nivolumab Drug: Temozolomide | NCT02617589 | Active, not recruiting | Phase III |
| Translational study of nivolumab in combination with bevacizumab for recurrent glioblastoma | Recurrent adult brain tumor | Drug: Nivolumab Drug: Bevacizumab | NCT03890952 | Recluting | Phase II |
| Immunological and functional characterization of cellular population CD45+ infiltrating human glioblastoma | Glioblastoma | NCT03687099 | Recluting | Observational | |
| Avelumab in patients with newly diagnosed glioblastoma multiforme | Glioblastoma Multiforme of brain | Biological: Avelumab | NCT03047473 | Active, not recruiting | Phase II |
| Capecitabine + bevacizumab in patients with recurrent glioblastoma | Glioblastoma | Drug: Capecitabine Drug: Bevacizumab | NCT02669173 | Recluting | Phase I |
| VXM01 plus avelumab combination study in progressive glioblastoma | Recurrent glioblastoma | Biological: VXM01 Biological: Avelumab | NCT03750071 | Recluting | Phase I, II |
| Immunotherapy (nivolumab and ipilimumab) before and after surgery for the treatment of recurrent or progressive high grade glioma in children and young adults | Glioblastoma Malignant glioma Recurrent glioblastoma Recurrent malignant glioma Recurrent grade III Glioma Grade III GLioma | Biological: Ipilimumab Biological: Nivolumab Drug: Placebo Administratio | NCT04323046 | Not yet recruiting | Phase I |
| CART-EGFRvIII + Pembrolizumab in GBM | Glioblastoma | Biological: CARTEGFRvIII T cells Biological: Pembrolizumab | NCT03726515 | Active, not recruiting | Phase I |
| INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM) | Glioblastoma | Biological: INO-5401 Biological: INO-9012 Biological: Cemiplimab Drug: Temozolomide | NCT03491683 | Active, not recruiting | Phase I, II |
| Combination adenovirus + pembrolizumab to trigger immune virus effects | Brain cancer Brain neoplasm Glioma Glioblastoma Gliosarcoma and other 3 | Biological: DNX-2401 Biological: Pembrolizumab | NCT02798406 | Active, not recruiting | Phase II |
| GMCI, nivolumab, and radiation therapy in treating patients with newly diagnosed high-grade gliomas | Glioma Malignant | Biological: AdV-tk Drug: Valacyclovir Drug: Temozolomide Biological: Nivolumab | NCT03576612 | Recluting | Phase I |
| Nivolumab, BMS-986205, and radiation therapy with or without temozolomide in treating patients with newly diagnosed glioblastoma | Glioblastoma | Biological: IDO1 Inhibitor BMS-986205 Biological: Nivolumab Drug: Temozolomide | NCT04047706 | Recluting | Phase I |
| Study of the IDO pathway inhibitor, indoximod, and temozolomide for pediatric patients with progressive primary malignant brain tumors | Glioblastoma Multiforme Glioma Gliosarcoma Malignant brain tumor Ependymoma and other 3 | Drug: Indoximod Drug: Temozolomide Drug: Cyclophosphamide Drug: Etoposide | NCT02502708 | Active, not recruiting | Phase I |
| A phase 0 study of AZD1775 in recurrent GBM patients | Glioblastoma | Biological: AZD1775 | NCT02207010 | Early phase I | |
| Nivolumab in people with IDH-mutant gliomas with and without hypermutator phenotype | Glioma Glioblastoma High grage glioma Low grade glioma Malignant glioma | Drug: Nivolumab | NCT03718767 | Recluting | Phase II |
| A pilot study to evaluate PBR PET in brain tumor patients treated with chemoradiation or immunotherapy | Intracranial tumors Glioblastoma Melanoma | Biological: Cancer immunotherapy Radiation: Radiation and chemotherapy | NCT02431572 | Completed | |
| HSV G207 with a single radiation dose in children with recurrent high-grade glioma | Neoplasms High grade glioma Glioblastoma multiforme Malignant glioma of brain Anaplastic astrocytoma of brain and other 3 | Drug: Biological G207 | NCT04482933 | Not yet recruiting | Phase II |
Summarized in the Table are the ongoing clinical trials present on ClinicalTrials.gov searching the keywords “glioblastoma multiforme” and “Checkpoint.” The research has been done adding the following filters: “Not yet recruiting”; “Recruiting”; “Enrolling by invitation”; “Active, not recruiting”; “Suspended”; “Terminate”; “Completed”; “Withdrawn”; “Unknown status”; “The research has been performed on October 21st, 2020.”