Table 2.
Main clinical trials on immunotherapies for high-grade gliomas.
| # | ClinicalTrials.gov Identifier | Title | Status | Phase | Diseases | # of Pts. Enrolled | Treatment | Locations |
|---|---|---|---|---|---|---|---|---|
| 1 | NCT03011671 | Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma | Suspended | I | Malignant Glioma of Brain | 24 | Acetazolamide, Temozolomide | USA |
| 2 | NCT02416999 | Ultra-low Dose Bevacizumab Plus Temozolomide for Recurrent High-grade Gliomas | Unknown | NA | Recurrent High-grade Glioma | 30 | Ultra-low dose Bevacizumab, Temozolomide | CHN |
| 3 | NCT01891747 | A Phase I Study of High-dose L-methylfolate in Combination With Temozolomide and Bevacizumab in Recurrent High Grade Glioma | Active, not recruiting | I | Malignant Glioma | 12 | Bevacizumab, Temozolomide, Vitamin C | USA |
| 4 | NCT04267146 | Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma | Recruiting | I, II | High Grade Glioma | 40 | Nivolumab, Temozolomide, Radiotherapy | FR |
| 5 | NCT00782756 | Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma | Completed | II | Brain Cancer, Malignant Glioma | 40 | Radiotherapy, Temozolomide, Bevacizumab | USA |
| 6 | NCT04547621 | HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM | Active, not recruiting | I, II | Glioma, Malignant | 50 | Radiation, Temozolomide | CHN |
| 7 | NCT01390948 | A Study of Bevacizumab (Avastin) in Combination With Temozolomide and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma | Completed | II | High Grade Glioma | 124 | Bevacizumab, Radiotherapy, Temozolomide | A |
| 8 | NCT00660621 | A Phase II Study Of Gliadel, Concomitant Temozolomide And Radiation, Followed By Dose Dense Therapy With Temozolomide Plus Bevacizumab For Newly Diagnosed Malignant High Grade Glioma | Unknown | II | Glioma | 40 | Temozolomide, Bevacizumab | USA |
| 9 | NCT03633552 | Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma | Recruiting | III | Glioblastoma Multiforme Anaplastic Astrocytoma | 62 | Temozolomide | IR |
| 10 | NCT01105702 | Temodar (Temozolomide), Bevacizumab, Lithium and Radiation for High Grade Glioma | Terminated | II | Brain Cancer | 28 | Temozolomide, Bevacizumab, Lithium Carbonate, Radiation | USA |
| 11 | NCT01740258 | Bevacizumab Beyond Progression (BBP) | Completed | II | Malignant Glioma, Glioblastoma, Gliosarcoma | 68 | Radiation Therapy, Temozolomide, Bevacizumab | USA |
| 12 | NCT01478321 | Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas | Terminated | II | Adult Anaplastic Astrocytoma Ependymoma Oligodendroglioma/Glioblastoma | 54 | Temozolomide, Bevacizumab Hypofractionated radiation therapy | USA |
| 13 | NCT00943826 | A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma | Completed | III | Glioblastoma | 921 | Bevacizumab, Temozolomide Radiation therapy | USA |
| 14 | NCT00884741 | Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma | Completed | III | Glioblastoma, Gliosarcoma, Supratentorial Glioblastoma | 637 | Radiation Therapy, Temozolomide, Bevacizumab | USA |
| 15 | NCT01046279 | Hypertension Monitoring in Glioma Patients Treated With Bevacizumab | Terminated | NA | Glioma | 40 | Bevacizumab | ZH |
| 16 | NCT00271609 | Bevacizumab for Recurrent Malignant Glioma | Completed | II | Recurrent High-Grade Gliomas | 88 | Bevacizumab | USA |
| 17 | NCT02833701 | Bevacizumab and Ascorbic Acid in Patients Treating With Recurrent High Grade Glioma | Terminated | I | Glioblastoma, Glioma | 9 | Ascorbic Acid, Bevacizumab | USA |
| 18 | NCT00595322 | Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma | Completed | NA | Recurrent Malignant Gliomas, Primary Brain Tumor | 25 | Bevacizumab, Radiation | USA |
| 19 | NCT00337207 | Bevacizumab in Treating Patients With Recurrent or Progressive Glioma | Completed | II | Central Nervous System Tumors | 55 | Bevacizumab | USA |
| 20 | NCT01091792 | Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM) | Completed | I | Glioblastoma Multiforme | 13 | Bevacizumab | USA |
| 21 | NCT00883298 | Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme | Completed | II | Recurrent Glioblastoma Multiforme Recurrent Gliosarcoma | 30 | Temozolomide, Bevacizumab | USA |
| 22 | NCT01811498 | Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM | Active, not recruiting | I, II | Glioblastoma Multiforme, Brain Tumor | 25 | Bevacizumab | USA |
| 23 | NCT01730950 | Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma | Active, not recruiting | II | Adult Giant Cell Glioblastoma, Glioblastoma, Adult Gliosarcoma Recurrent Adult Brain Tumor | 182 | Bevacizumab, Radiation therapy | USA |
| 24 | NCT02761070 | Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III | Recruiting | III | Recurrent Glioblastoma | 146 | Temozolomide, Bevacizumab | J |
| 25 | NCT01209442 | Hypofractionated Intensity-Modulated Radiation Therapy With Temozolomide and Bevacizumab for Glioblastoma Multiforme | Completed | II | Glioblastoma Multiforme | 30 | Bevacizumab, Temozolomide Radiation Therapy | USA |
| 26 | NCT01125046 | Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas | Completed | II | Central Nervous System Tumors | 50 | Bevacizumab | USA |
| 27 | NCT01526837 | Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence | Terminated | I | Glioblastoma Multiforme | 1 | Bevacizumab | USA |
| 28 | NCT01443676 | Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma | Completed | II | Glioblastoma | 75 | Bevacizumab, Radiation therapy | USA |
| 29 | NCT00590681 | Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme | Completed | II | Glioblastoma Multiforme | 62 | Bevacizumab, Temozolomide | USA |
| 30 | NCT03925246 | Efficacy of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas | Active, not recruiting | II | High Grade Glioma, Brain Cancer | 43 | Nivolumab | FR |
| 31 | NCT00345163 | A Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN) | Completed | II | Glioblastoma | 167 | Bevacizumab, Irinotecan | NA |
| 32 | NCT03890952 | Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma | Recruiting | II | Recurrent Adult Brain Tumor | 40 | Nivolumab, Bevacizumab | DNK |
| 33 | NCT01498328 | A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma | Completed | II | Glioblastoma | 127 | Rindopepimut (CDX-110) with GM-CSF Bevacizumab, KLH | USA |
| 34 | NCT03743662 | Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma | Recruiting | II | Glioblastoma | 94 | Re-irradiation, Bevacizumab Nivolumab, Re-resection | USA |
| 35 | NCT03452579 | Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM | Active, not recruiting | II | Glioblastoma | 90 | Nivolumab, Standard/Reduced Dose Bevacizumab | USA |
| 36 | NCT02550249 | Neoadjuvant Nivolumab in Glioblastoma | Completed | II | Glioblastoma Multiforme | 29 | Nivolumab | ES |
| 37 | NCT04195139 | Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM | Recruiting | II | Glioblastoma Multiforme | 102 | Nivolumab, Temozolomide | A |
| 38 | NCT02667587 | An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) | Active, not recruiting | III | Brain Neoplasms | 693 | Nivolumab, Temozolomide, Radiotherapy | USA |
| 39 | NCT02617589 | An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) | Active, not recruiting | III | Brain Cancer | 560 | Nivolumab, Temozolomide, Radiotherapy | USA |
| 40 | NCT01213407 | Dendritic Cell Cancer Vaccine for High-grade Glioma | Completed | II | Glioblastoma Multiforme | 87 | Trivax, Temozolomide, Surgery, Radiotherapy | AU |
| 41 | NCT02529072 | Nivolumab With DC Vaccines for Recurrent Brain Tumors | Completed | I | Malignant Glioma, Astrocytoma | 6 | Nivolumab | USA |
| 42 | NCT03718767 | Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype | Recruiting | II | Malignant Glioma of Brain | 95 | Nivolumab | USA |
| 43 | NCT01480479 | Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma | Completed | III | Malignant Glioma of Brain | 745 | Rindopepimut (CDX-110) with GM-CSF Temozolomide, KLH | USA |
| 44 | NCT01058850 | Phase I Rindopepimut After Conventional Radiation in Children w/Diffuse Intrinsic Pontine Gliomas | Terminated | I | Brain Cancer, Brain Stem Tumors | 3 | Rindopepimut | USA |
| 45 | NCT00045968 | Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer | Unknown | III | Glioblastoma | 348 | Dendritic cell immunotherapy | USA |
| 46 | NCT02808364 | Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2) | Active, not recruiting | I | Glioblastoma | 10 | Personalized cellular vaccine | CHN |
| 47 | NCT02709616 | Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC) | Active, not recruiting | 10 | Glioblastoma | 10 | Personalized cellular vaccine | CHN |
| 48 | NCT02209376 | Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma | Terminated | I | Patients With Residual or Reccurent EGFRvIII+ Glioma | 11 | CART-EGFRvIII T cells | USA |
| 49 | NCT03726515 | CART-EGFRvIII + Pembrolizumab in GBM | Active, not recruiting | I | Glioblastoma | 7 | CART-EGFRvIII T cells, Pembrolizumab | USA |
| 50 | NCT02664363 | EGFRvIII CAR T Cells for Newly-Diagnosed WHO Grade IV Malignant Glioma | Terminated | I | Glioblastoma, Gliosarcoma | 3 | EGFRvIII CAR T cells | USA |
| 51 | NCT01109095 | CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM | Completed | I | Glioblastoma Multiforme | 16 | HER.CAR CMV-specific CTLs | USA |
| 52 | NCT02208362 | Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma | Recruiting | I | Glioblastoma, Recurrent Malignant Glioma | 92 | IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes | USA |
| 53 | NCT04003649 | IL13Ralpha2-Targeted Chimeric Antigen Receptor (CAR) T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With Recurrent or Refractory Glioblastoma | Recruiting | I | Recurrent/Refractory Glioblastoma | 60 | IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells, Ipilimumab, Nivolumab | USA |
| 54 | NCT03383978 | Intracranial Injection of NK-92/5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma | Recruiting | I | Glioblastoma | 30 | NK-92/5.28.z | DE |
| 55 | NCT03392545 | Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1) | Recruiting | I | High Grade Glioma, Glioblastoma, Glioma of Brainstem | 30 | Combined immune adjuvants and radiation | CHN |
| 56 | NCT03389230 | Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma | Recruiting | I | High Grade Glioma, Glioblastoma | 42 | HER2(EQ)BBζ/CD19t+ Tcm | USA |
| 57 | NCT03347097 | Adoptive Cell Therapy of Autologous TIL and PD1-TIL Cells for Patients With Glioblastoma Multiforme | Active, not recruiting | I | Glioblastoma Multiforme | 40 | TIL | CHN |
| 58 | NCT03344250 | Phase I EGFR BATs in Newly Diagnosed Glioblastoma | Recruiting | I | Glioblastoma Multiforme | 18 | EGFR BATs with SOC RT and TMZ | USA |
| 59 | NCT03170141 | Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme | Enrolling by invitation | I | Glioblastoma Multiforme | 20 | Antigen-specific IgT cells | CHN |
| 60 | NCT02937844 | Pilot Study of Autologous Chimeric Switch Receptor Modified T Cells in Recurrent Glioblastoma Multiforme | Unknown | I | Glioblastoma Multiforme | 20 | Anti-PD-L1 CSR T cells, Cyclophosphamide, Fludarabine | CHN |
| 61 | NCT02799238 | Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma | Completed | II | Glioblastoma | 62 | ALECSAT, Radiotherapy, Temozolomide | SE |
| 62 | NCT02060955 | Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan | Terminated | II | Glioblastoma Multiforme | 25 | ALECSAT, Bevacizumab/Irinotecan | DK |
| 63 | NCT01588769 | A Phase I Study to Investigate Tolerability and Efficacy of ALECSAT Administered to Glioblastoma Multiforme Patients | Completed | I | Glioblastoma Multiforme | 23 | ALECSAT cell based immunotherapy | DK |
| 64 | NCT01454596 | CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII | Completed | I, II | Malignant Glioma, Glioblastoma, Gliosarcoma | 18 | Epidermal growth factor receptor(EGFRv)III Chimeric antigen receptor (CAR) transduced PBL, Aldesleukin, Fludarabine, Cyclophosphamide | USA |
| 65 | NCT01144247 | Cellular Immunotherapy Study for Brain Cancer | Completed | I | Malignant Glioma of Brain | 10 | Alloreactive CTL | USA |
| 66 | NCT01082926 | Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolytic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2 | Completed | I | Malignant Glioma of Brain | 6 | Therapeutic allogeneic lymphocytes, Aldesleukin | USA |
| 67 | NCT00730613 | Cellular Adoptive Immunotherapy Using Genetically Modified T-Lymphocytes in Treating Patients With Recurrent or Refractory High-Grade Malignant Glioma | Completed | I | Central Nervous System Tumors | 3 | Therapeutic autologous lymphocytes | NA |
| 68 | NCT00331526 | Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme | Completed | II | Central Nervous System Tumors | 83 | Aldesleukin, Therapeutic autologous lymphocytes, Adjuvant therapy, Surgery | USA |
| 69 | NCT00004024 | Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma | Completed | II | Central Nervous System Tumors | 60 | Aldesleukin, Autologous tumor cell vaccine, Muromonab-CD3, Sargramostim, Therapeutic autologous lymphocytes, Surgical procedure, Radiation therapy | USA |
A: Australia; ALECSAT: Autologous Lymphoid Effector Cells Specific Against Tumor; AU: Austria; CHN: China; CTL: cytotoxic T-lymphocytes; DE: Denmark; EGFR BATs: EGFR Bi-armed Activated T-cells; EGFR: epidermal growth factor; EGFRvIII: epidermal growth factor receptor variant III; ES: Spain; FR: France; GBM: Glioblastoma; HER2(EQ)BBζ/CD19t+ Tcm: preparation of genetically modified autologous central memory enriched T-cells (Tcm) expressing a chimeric antigen receptor consisting of an anti-human epidermal growth factor 2 (HER2) variable fragment that is linked to the signaling domain of the T-cell antigen receptor complex zeta chain (BBζ), and truncated cluster of differentiation (CD)19; IL-13Rα2: interleukin-13 receptor α2; IR: Iran; J: Japan; NA: Not Available; PBL: peripheral blood lymphocytes; PD-L1 CSR: programmed death Ligand 1 chimeric switch receptor; RT: Radiotherapy; SE: Sweden; TIL: Tumor-infiltrating T-Lymphocyte; TMZ: temozolomide; USA: United States; ZH: Zurich.