Table 2.
Ongoing clinical trials of immunotherapy alone and combinations in GBM
| Treatment | Target | NCT Number | Phase | Patient population | Design |
|---|---|---|---|---|---|
| Immune checkpoint inhibitors | |||||
| Nivolumab, ipilimumab | PD-1, CTLA-4 | NCT04396860 | II/III | Newly diagnosed GBM, MGMT unmethylated | RT + TMZ vs. RT+nivolumab+ipilimumab |
| Nivolumab, BMS-986016 | PD-1, LAG-3 | NCT03493932 | I | Recurrent GBM | Nivolumab+BMS-986016 |
| BMS-986016, urelumab, nivolumab | LAG-3, CD137, PD-1 | NCT02658981 | I | Recurrent GBM | BMS-986016 (A1), Urelumab (A2), BMS-986016+Nivolumab (B1), Urelumab+Nivolumab (B2) |
| MBG453, spartalizumab | TIM-3, PD-1 | NCT03961971 | I | Recurrent GBM | Stereotactic radiosurgery+MBG453+spartalizumab |
| AB154, AB122 | TIGIT, PD-1 | NCT04656535 | 0/I | Recurrent GBM | AB154 + AB122 (Safety A), AB154 (B1), AB122 (B2), AB154 + AB122 (B3), Placebo (B4) |
| BMS-986205, nivolumab | IDO1, PD-1 | NCT04047706 | I | Newly diagnosed GBM | BMS-986205+Nivolumab+RT + TMZ vs. BMS-986205+Nivolumab+RT |
| Indoximod, TMZ, bevacizumab | IDO1 | NCT02052648 | I/II | Recurrent GBM | Indoximod+TMZ (I), Indoximod+TMZ+bevacizumab (II), Indoximod+TMZ + RT (III) |
| Adoptive T cell therapies | |||||
| TILs | Tumor cell | NCT05333588 | I | Advanced Stage of GBM | TILs |
| TILs | Tumor cell | NCT04943913 | I | Malignant glioma | TILs |
| CAR-T cells | PD-1 | NCT02873390 | I/II | EGFR+ Advanced Solid Tumor | Herin CAR-PD-1 cells |
| CAR-T cells | PD-L1 | NCT02937844 | I | Recurrent GBM | Anti-PD-L1 CAR T cells |
| CAR-T cells | CTLA-4, PD-1 | NCT03182816 | I/II | EGFR+ Advanced Solid Tumor | Anti-CTLA-4/PD-1 expressing EGFR-CAR-T cells |
| CAR-T cells | IL-13Rα2 | NCT04003649 | I | Recurrent GBM | IL-13Rα2-CAR T cells+nivolumab+ipilimumab (I), IL-13Rα2-CAR T cells+nivolumab (II), IL-13Rα2-CAR T cells (III) |
| Cancer vaccines | |||||
| INO-5401, INO-9012 | hTERT, WT-1, PSMA | NCT03491683 | I/II | Newly diagnosed GBM | INO-5401 + INO-9012+cemiplimab+RT + TMZ (MGMT unmethylated vs. MGMT methylated) |
| SurVaxM | Survivin | NCT02455557 | II | Newly diagnosed GBM | SurVaxM+TMZ |
| IMA950 | 11 TAAs | NCT03665545 | I/II | Recurrent GBM | IMA950+Poly-ICLC vs. IMA950/Poly-ICLC+pembrolizumab |
| Personalized vaccine | TSAs | NCT05743595 | I | Newly diagnosed GBM, MGMT unmethylated | Personalized neoantigen DNA vaccine+retifanlimab |
| ATL-DCs | Autologous tumor antigens | NCT04201873 | I | Recurrent GBM | Pembrolizumab+ATL-DCs+poly-ICLC vs. Placebo+ATL-DCs+poly-ICLC |
| Oncolytic viral therapies | |||||
| PVSRIPO | Poliovirus targeting tumor cells | NCT04479241 | II | Recurrent GBM | PVSRIPO+pembrolizumab |
| PVSRIPO | Poliovirus targeting tumor cells | NCT02986178 | II | Recurrent GBM | PVSRIPO |
| PVSRIPO | Poliovirus targeting tumor cells | NCT03973879 | I/II | Recurrent GBM | PVSRIPO+atezolizumab |
| PVSRIPO | Poliovirus targeting tumor cells | NCT04479241 | II | Recurrent GBM | PVSRIPO+pembrolizumab |
| PVSRIPO | Poliovirus targeting tumor cells | NCT03973879 | I/II | Recurrent GBM | PVSRIPO+atezolizumab |
| AdV-tk | Adenovirus delivering HSV-TK | NCT03576612 | I | Newly diagnosed GBM | AdV-tk+nivolumab+RT + TMZ (MGMT unmethylated vs. MGMT methylated) |
| Ad-RTS-hIL-12 | Adenovirus targeting tumor cells | NCT04006119 | II | Recurrent or progressive GBM | Ad-RTS-hIL-12+cemiplimab |
ATL-DCs autologous tumor lysate pulsed dendritic cells, CAR chimeric antigen receptor, CTLA-4 cytotoxic T-lymphocyte associated protein 4, EGFR epidermal growth factor receptor, GBM glioblastoma, HSV-TK herpes simplex virus thymidine kinase, hTERT human telomerase reverse transcriptase, IL-13Ra2 interleukin-13 receptor subunit alpha 2, LAG-3 lymphocyte activation gene 3, MGMT O6-methylguanine-DNA methyltransferase, PD-1 programmed cell death protein 1, PD-L1 programmed cell death ligand 1, Poly-ICLC polyinosinic-polycytidylic acid with polylysine and carboxymethylcellulose, PSMA prostate-specific membrane antigen, RT radiotherapy, TAAs tumor-associated antigens, TIGIT T cell immunoreceptor with immunoglobulin and ITIM domain, TILs tumor infiltrating lymphocytes, TIM-3 T cell immunoglobulin and mucin domain 3, TMZ temozolomide, WT-1 wilms’ tumor 1