Table 1.
Active phase III trials
| Trial Name (Acronym) | Trial ID | Phase | Design | Inclusion Criteria | Arms | Primary Outcome | Number of Patients | Results Expected | Status | Drug Name (Mechanism) |
|---|---|---|---|---|---|---|---|---|---|---|
| VAL‐083 Phase 3 Study in Temozolomide‐Avastin (Bevacizumab) Recurrent GB (STAR‐3) | NCT03149575 | III | Randomized, open‐label, parallel assignment | Recurrence of GB on bevacizumab after SOC | VAL‐083 (Dianhydrogalactitol) vs Physician's Choice Salvage Therapy (TMZ, Lomustine, or Carboplatin) | OS | 180 | 2019 | Active, not recruiting | VAL‐083 (Alkylating Agent) |
| Intraoperative Radiotherapy in Newly Diagnosed GB (INTRAGO‐II) | NCT02685605 | III | Prospective, randomized, 2‐arm open‐label | Newly‐suspected GB, age 18‐80 y, felt to be amenable to GTR, KPS ≥60 | Surgery+interoperative radiotherapy (20‐30 gy) + Stupp vs Sugery+Stupp | Median PFS at 24 mo | 314 | 2021 | Recruiting | |
| Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed GB Biopsy‐Only Subjects (INTACT) | NCT03393000 | III | Open‐label, randomized‐controlled | Age 18‐70 y, KPS ≥60, biopsy‐only GB, no previous chemo/RT | SOC vs SOC + Trans‐Sodium Crocetinate | OS | 22 | 2022 | Active, not recruiting | Radiosensitizing Agent |
| A Study of ABT‐414 in Subjects With Newly Diagnosed GB With Epidermal Growth Factor Receptor (EGFR) Amplification (INTELLANCE1) | NCT02573324 | III | Randomized, parallel‐assignment, quadruple‐blinded | Age 18‐99 y, KPS ≥70, Confirmed EGFR amplification | TMZ + Radiation+Placebo vs TMZ + Radiation+ABT‐414 | OS | 640 | 2021 | Recruiting | ABT‐414 (EGFR inhibitor) |
| Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed GB | NCT02152982 | II/III | Randomized, parallel‐assignment, double‐blinded | Age ≥18 y, MGMT promoter Methylation present, has completed SOC, but no other adjuvant treatment | TMZ + Placebo vs TMZ + Veliparib | OS | 440 | 2022 | Active, not recruiting | Veliparib (PARP inhibitor) |
| An Investigational Immuno‐therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With GB | NCT02667587 | III | Randomized, parallel‐assignment, triple‐blind | Age ≥18 y, KPS ≥70, MGMT promoter Methylation, Newly Diagnosed GB | Nivolumab+TMZ + RT vs Placebo + TMZ + RT | OS, PFS | 693 | 2023 | Active, not recruiting | Nivolumab (PD‐1 inhibitor) |
| An Investigational Immuno‐therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly‐diagnosed Patients With GB (CheckMate 498) | NCT02617589 | III | Randomized, parallel‐assignment, open‐label | Age ≥18 y, Newly‐Diagnosed GB, MGMT promoter Unmethylated, KPS ≥70 | Nivolumab + RT vs TMZ + RT | OS | 550 | 2019 | Recruiting | Nivolumab (PD‐1 inhibitor) |
| The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma (Toca5) | NCT02414165 | II/III | Randomized, parallel‐assignment, open‐label | Age 18‐75 y, recurrent GB or AA after first‐line therapy | Surgery + Toca 511 + Toca FC vs Surgery + TMZ OR Lomustine OR Bevacizumab | OS | 403 | 2023 | Active, not recruiting | Flucytosine (The Toca 511 retroviral vector converts 5 fluorocytosine to 5‐FU) |
| A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in GB Patients (CheckMate 143) | NCT02017717 | III | Randomized, parallel assignment, open label | Newly diagnosed MGMT promoter unmethylated or recurrent GB, KPS ≥70 | Nivolumab vs Nivolumab + Ipilimumab vs Bevacizumab | OS | 626 | 2019 | Active, not recruiting | Nivolumab (PD‐1 inhibitor) |
| Standard Chemotherapy vs Chemotherapy Guided by Cancer Stem Cell Test in Recurrent GB (CSCRGBM) | NCT03632135 | III | Randomized, parallel‐assignment, quadruple‐blinded | Age >18 y, recurrent GB | Physician Choice Treatment vs Chemotherapy per drug assay ChemoID test | OS | 300 | 2022 | Recruiting | The ChemoID drug response assay reports a prioritized list of effective and ineffective chemotherapies. The test is designed to target cancer stem cells to mitigate tumor relapse. |
Abbreviations: AA, anaplastic astrocytoma; AO, anaplastic oligodendroglioma; EGFR, epidermal growth factor receptor; GB, glioblastoma; GTR, gross total resection; KPS, Karnofsky Performance Status; LE, life expectancy; MGMT, O6‐methylguanine‐DNA methyltransferase; OS=overall survival; PARP, poly‐ADP ribose polymerase; PD‐1, programmed‐death 1; PFS=progression‐free survival; RT, radiotherapy; SOC=standard of care; TMZ, temozolomide; 5‐FU, 5‐fluorouracil.