Table 1.
Published phase II and III trials with immunotherapy in GB.
| Clinical Trial | Treatment | N | Age Range | Outcomes | Relevant Toxicities |
|---|---|---|---|---|---|
| Immune checkpoint inhibitors | |||||
| Lim et al. (phase III) (CheckMate-548) [104] | TMZ + RT ± nivo |
716 | 18–81 | mPFS 10.6 m (nivo) vs. 10.3 m (pbo); mOS; mOS 31.3 m vs. 33.0 m | Grade 3/4 AEs: 52.4% (nivo) vs. 33.6% (pbo) |
| Omuro et al. (phase III) (CheckMate-498) [105] | Nivo + RT vs. TMZ + RT | 560 | 18–83 | mPFS 6.0 m (nivo) vs. 6.2 m (TMZ); mOS 13.4 m vs. 14.9 m; ORR 7.8% vs. 7.2% | Grade 3/4 AEs: 21.9% (nivo) vs. 25.1% (TMZ) |
| Reardon et al. (phase III) (CheckMate-143) [106] | Nivo vs. beva (after CT-RT) | 369 | 22–77 | mPFS 1.5 m (nivo) vs. 3.5 m (beva); mOS 9.8 m vs. 10.0 m; ORR 7.8% vs. 23.1% | Grade 3/4 AEs: 18.1% (nivo) vs. 15.2% (beva) |
| Nayak et al. (phase II) [110] | Pembro + beva (A) vs. pembro (B) | 80 | 42–62 (IQR) |
PFS at 6 m: 26% (A) vs. 6.7% (B); mOS 8.8 m vs. 10.3 m; ORR 20% vs. 0% | Grade 3/4 AEs: 32% (A) vs. 13% (B) |
| Cloughesy et al. (phase II) [111] | Pembro (neo + adj [A] vs. adj [B]) | 35 | 57.4 (mean) |
mPFS 3.3 m (A) vs. 2.4 m (B); mOS 13.7 m vs. 7.5 m | Grade 3/4 AEs: 32% (A) vs. 13% (B) |
| Schalper et al. (phase II) [112] | (Neo)adjuvant nivo | 30 | NA | mPFS 4.1 m; mOS 7.3 m; higher immune cell infiltration and TCR diversity | No grade 3/4 AEs |
| Weathers et al. (phase I/II) [113] | Atezo + TMZ + RT | 60 | NA | mPFS 9.7 m; mOS 17.1 m | Grade 3/4 AEs: 55% |
| Reardon et al. (phase II) [114] | Nivo + varlilumab | 28 | NA | mOS 9.7 m; DCR 39.3% (2 PR, 9 SD) | NA |
| Oncolytic viruses and vaccines | |||||
| Todo et al. (phase II) [115] |
G47 delta (HSV-1) | 19 | 25–73 | mOS 20.02 m; OS at 1 y: 84.2%, DCR 100% (18 SD, 1 PR lasting > 2 y) | Grade 3 AEs: 26.3% Grade 4 AEs: 10.5% |
| Weller et al. (phase III) (ACT IV) [116] |
Rindopepimut (EGFRvIII vaccine) vs. pbo | 745 | 51–64 (IQR) |
No significant difference in OS (HR 1.01; p = 0.93) | Serious AEs: seizure (5% vs. 6%) and brain edema (2% vs. 3%) |
| Liau et al. (phase III) [117] |
TMZ ± DCvax (after CT-RT) | 331 | 19–73 | mOS (ITTp) 23.1 m; OS at 1 y: 89.3%; OS at 2 y: 46.2% | Similar rate of AEs in both groups |
| Narita et al. (phase III) [118] | Personalized peptide vaccine (PPV) vs. BSC | 88 | 20–74 | No significant difference in OS (8.4 m vs. 8.0 m) | Grade 3/4 AEs: 39.7% vs. 36.7% |
The table summarizes the clinical trials, treatment administered, number of treated patients, age range, outcomes, and toxicities.