Table 2.
Phase II/III clinical trials with peptide vaccines in glioblastoma.
| Clinical Trial | Phase | Target | Treatment | Control | Indication | # Patients | Endpoint | Outcome |
|---|---|---|---|---|---|---|---|---|
| HSPPC-96 NCT00905060 |
II | Autologous peptides | SOC, PEP | None | P GB | 46 | OS | 23.8 mo |
| HSPPC-96 NCT00293423 24335700 |
II | Autologous peptides | SS, PEP | None | R GB | 41 | OS6 | 90.2% |
| HSPPC-96 NCT01814813 |
II | Autologous peptides | PEP Bevacizumab |
Bevacizumab | R GB | 30 | OS | No impact |
| ACT-IV NCT01480479 28844499 |
III | EGFRvIII | SOC, PEP | SOC, KLH | P GB EGFRvIII+ |
371 | OS | No impact |
| ACT-III 25586468 |
II | EGFRvIII | SOC, PEP | Historical | P GB EGFRvIII+ |
65 | PFS5.5 | 66% vs. 45% |
| ACT-II 21149254 |
II | EGFRvIII | SOC, PEP | Historical | P GB EGFRvIII+ |
22 | (OS) | 23.6 vs. 15.0 mo |
| ReACT NCT01498328 |
II | EGFRvIII | PEP Bevacizumab |
KLH Bevacizumab |
R GB EFGRvIII+ |
33 | PFS6 | 27% vs. 11% |
| ACTIVATe NCT00643097 20921459 |
II | EGFRvIII | SOC, PEP | Historical | P GB EGFRvIII+ |
18 | PFS6 | 94% vs. 59% |
| ITK-1 UMIN000006970 30500939 |
III | Multiple TAA | PEP | Placebo | R GB HLA-A24+ |
Treatment: 58 Control: 30 |
OS | No impact |
| SL-701 NCT02078648 |
II | Multiple TAA | PEP Bevacizumab |
None | R GB HLA-A2+ |
74 | OS12 | 43% |
| IMA-950 NCT01920191 30753611 |
I/II | Multiple TAA | SOC, PEP | None | P GB HLA-A2+ |
16 | (OS) | 19 mo |
| SurVaxM~ NCT02455557 |
II | Survivin | SOC, PEP | None | P GB HLA-A2, -A3, -A11 and -A24+ |
55 | OS12 | 70.8% |
Abbreviations: TAA, tumor-associated antigen; PEP, peptide vaccination; KLH, Keyhole limpet hemocyanin; SS, second surgical procedure; P, primary; R, recurrent; GB, glioblastoma; HLA, human leukocyte antigen; #, number of; PFS5.5, 5.5-mo PFS; OS6, 6-mo OS; PFS6, 6-mo PFS; OS12, 12-mo OS. The ‘Endpoint’ column indicates which primary survival endpoint was assessed in each clinical trial. If a study only used a secondary survival endpoint, the outcome measure was placed between parentheses.