Table 1.
Recent phase II/III clinical trials of ICBs for GBM treatment.
| Target | Identifier | Title | Phase | Treatment approach | Patient | Status |
|---|---|---|---|---|---|---|
| PD-1 | NCT02017717 (CheckMate 143) | A randomized phase 3 open label study of nivolumab versus bevacizumab and multiple phase 1 safety cohorts of nivolumab or nivolumab in combination with ipilimumab across different lines of glioblastoma | 3 | Nivolumab Bevacizumab Ipilimumab |
rGBM | Completed |
| NCT02617589 (Checkmate 498) | A randomized phase 3 open label study of nivolumab vs. temozolomide each in combination with radiation therapy in newly diagnosed adult subjects with unmethylated MGMT (tumor o-6-methylguanine DNA methyltransferase) glioblastoma | 3 | Nivolumab Temozolomide Radiotherapy |
GBM (Unmethylated MGMT) | Completed | |
| NCT02667587 (Checkmate 548) | A randomized phase 3 single-blind study of temozolomide, plus radiation therapy combined with nivolumab or placebo in newly diagnosed adult subjects with MGMT-methylated glioblastoma | 3 | Nivolumab Temozolomide Radiotherapy |
nGBM | Active | |
| NCT02798406 | Combination adenovirus + pembrolizumab to trigger immune virus effects | 2 | Pembrolizumab Adenovirus |
rGBM | Completed | |
| NCT02550249 | Phase 2 study of neoadjuvant nivolumab in patients with glioblastoma multiforme | 2 | Nivolumab | nGBM and rGBM | Completed | |
| NCT02336165 | Phase 2 study to evaluate the clinical efficacy and safety of durvalumab (MEDI4736) in patients with glioblastoma (GBM) | 2 | Durvalumab | nGBM and rGBM | Completed | |
| NCT02337491 | Phase 2 study of pembrolizumab (MK-3475) with and without bevacizumab for recurrent glioblastoma | 2 | Pembrolizumab Bevacizumab |
rGBM | Completed | |
| NCT03018288 | Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) | 2 | Pembrolizumab Temozolomide Radiotherapy HSPPC-96 |
nGBM | Completed | |
| NCT03405792 | Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma | 2 | Temozolomide TTFields Pembrolizumab |
nGBM | Active | |
| NCT02337686 | Pharmacodynamic study of pembrolizumab in patients with recurrent glioblastoma | 2 | Pembrolizumab | rGBM | Active | |
| NCT03452579 | A randomized phase 2 open label study of nivolumab plus standard dose bevacizumab versus nivolumab plus low dose bevacizumab in recurrent glioblastoma (GBM) | 2 | Nivolumab Bevacizumab |
rGBM | Active | |
| NCT03743662 | Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma | 2 | Nivolumab Bevacizumab Radiotherapy |
rGBM (Methylated MGMT) | Active | |
| NCT03661723 | Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma | 2 | Pembrolizumab Bevacizumab Radiotherapy |
rGBM | Active | |
| NCT03665545 | Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma | 1/2 | Pembrolizumab IMA950/Poly-ICLC |
rGBM | Active | |
| NCT04479241 | LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma | 2 | Pembrolizumab Lerapolturev |
rGBM | Active | |
| NCT04195139 | Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM (NUTMEG) | 2 | Nivolumab Temozolomide |
nGBM (Elderly) | Active | |
| NCT04013672 | Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence | 2 | Pembrolizumab SurVaxM |
rGBM (at first recurrence) | Active | |
| NCT03890952 | Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma | 2 | Nivolumab Bevacizumab |
rGBM | Active | |
| NCT03899857 | Pembrolizumab for Newly Diagnosed Glioblastoma (PERGOLA) | 2 | Pembrolizumab | nGBM | Active | |
| NCT03491683 | INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) | 1/2 | Cemiplimab INO-5401 INO-9012 |
nGBM | Active | |
| PD-L1 | NCT03174197 | Atezolizumab in Combination With Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma | 1/2 | Atezolizumab Temozolomide Radiotherapy |
nGBM | Active |
| NCT03750071 | VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma | 1/2 | Avelumab VXM01 |
Progressive GBM | Active | |
| CTLA-4 | NCT04817254 | Phase II Trial Evaluating the Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma | 2 | Ipilimumab Nivolumab TMZ |
nGBM or Gliosarcoma | Recruiting |
| NCT02794883 | A phase 2, open label, clinical trial of pre surgical and adjuvant treatment of recurrent malignant glioma with tremelimumab and durvalumab (MEDI4736) alone and in combination to determine immunologic changes from treatment | 2 | Tremelimumab Durvalumab |
Recurrent malignant glioma | Completed | |
| NCT03367715 | Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma | 2 | Ipilimumab Nivolumab Radiotherapy |
nGBM (Unmethylated MGMT) | Completed | |
| NCT04396860 | Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma | 2/3 | Ipilimumab Nivolumab Radiotherapy |
nGBM (Unmethylated MGMT) | Active | |
| IDO-1 | NCT02052648 | A phase 1/2 study of the combination of indoximod and temozolomide for adult patients with temozolomide-refractory primary malignant brain tumors | 1/2 | Indoximod Temozolomide |
Recurrent malignant glioma | Completed |
Data from ClinicalTrials.gov.