Table 2.
Key Vaccine Clinical Trials in GBM
| Vaccine | Vaccine Category | NCT | Disease | Additional therapy | Control | Phase | n | Status | Results (treatment v. control) |
|---|---|---|---|---|---|---|---|---|---|
| Rindopepimut | Peptide | NCT01480479 (ACT IV) | new diagnosis GBM | GM-CSF + TMZ | KLH + TMZ | 3 | 745 | Terminated early (11/2016) | mOS 20.1 months v. 20.0 months |
| NCT00458601 ACT III | new diagnosis GBM | GM-CSF + TMZ | none | 2 | 82 | Completed 5/2016 | mOS 21.8m | ||
| NCT01498328 (ReACT) | recurrent GBM | GM-CSF + BEV | KLH + BEV | 2 | 127 | Completed 2015 | mOS 12.0m v. 8.8m | ||
| DC-Vax | DC vaccine autologus tumor pulsed | NCT00045968 | new diagnosis GBM | unpulsed PBMC | 3 | 348 | Active, not recruiting | ||
| NCT03014804 | recurrent GBM | Nivolumab | vaccine alone | 2 | 30 | planned to open 1/2019 | |||
| NCT02146066 | expanded access for patients who sceen-failed | ||||||||
| HSPPC-96 | Custom Peptide | NCT03018288 | new diagnosis GBM (MGMT -, IDH wt) | pembrolizumab + TMZ | pembrolizumab + TMZ | 2 | 108 | Ongoing | |
| NCT00905060 | new diagnosis GBM | TMZ | none | 2 | 46 | completed | mOS 23.8m | ||
| NCT00293423 | GTR recurrent GBM | TMZ | none | 2 | 41 | completed | mOS 10.65m | ||
| NCT01814813 | recurrent GBM | BEV | BEV | 2 | 90 | not recruiting | |||
| NCT02722512 | new and recurrent HGG and recurrent ependymoma 3-21 years | 1 | 20 | ||||||
| pp65 DC | DC - peptide pulsed CMV antigens | NCT02465268 (ATTAC-II) | new diagnosis GBM | GM-CSF + Td +TMZ | unpulsed PBMC | 2 | 150 | recruiting planned to open | |
| NCT03688178 (DERIVc) | new diagnosis GBM | variliumab | vaccine alone | 2 | 112 | 1/2019 | |||
| NCT03615404 | new diagnosis GBM <18 years old | GM-CSF + Td +TMZ | none | 1 | 10 | recruiting | |||
| NCT00639639 | new diagnosis GBM | Td + TMZ | none | 1 | 16 | completed | |||
| NCT02529072 (AVERT) | recurrent HGG | nivolumab | 1 | 7 | not recruiting | ||||
| ICT-107 | DC -peptide pulsed | NCT01280552 | new diagnosis GBM | TMZ | unpulsed DC cells | 2 | 124 | completed | mOS 18.3 v. 16.7m |
| NCT 02546102 | new diagnosis GBM | TMZ | Control injection | 3 | 414 | suspended due to funding | |||
| TVI-Brain-1 | DC stimulated killer T cells | NCT01290692 | recurrent GBM | GM-CSF | 2 | 86 | completed 2/2014 | Company website notes patient 5 years survivor and mOS 50% greater than historical controls |
GTR gross total resection, rGBM recurrent GBM, TMZ temozolomide, BEV bevacizumab, nivo nivolumab, pembro pembrolizumab, mOS median overall survival, Td Tetanus-Diphtheria Toxoid, DC dendritic cell, KLH Keyhole limpet hemocyanin, HGG high grade glioma