Table 1.
Clinical Trials of Immune Checkpoint Inhibitors in GBM
| Source | Checkpoint Target |
Antibody | Name (US) |
Phase | No. of Patients |
Title of Trial | National Clinical Trial Reg. # |
|---|---|---|---|---|---|---|---|
| BMS | PD-1 | Nivolumab | Opdivo | I | 19 | Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma | NCT02648633 |
| Nivolumab | Opdivo | II | 29 | Neoadjuvant Nivolumab in Glioblastoma (Neo-nivo) | NCT02550249 | ||
| Nivolumab | Opdivo | I | 26 | Hypofractionated Stereotactic Irradiation With Nivolumab in Patients With Recurrent High Grade Gliomas | NCT02829931 | ||
| Nivolumab | Opdivo | I | 66 | Nivolumab With DC Vaccines for Recurrent Brain Tumors (AVERT) | NCT02529072 | ||
| Nivolumab | Opdivo | II | 320 | Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer). (CheckMate548) | NCT02667587 | ||
| Nivolumab | Opdivo | III | 550 | Study of Nivolumab Compared to Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate 498) | NCT02617589 | ||
| Nivolumab | Opdivo | II | 30 | Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Vaccine and Nivolumab in Treating Patients With Recurrent Glioblastoma | NCT03014804 | ||
| CTLA-4/PD-1 | Ipilimumab/Nivolumab | Yevroy/Opdivo | III | 440 | A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients (CheckMate 143) | NCT02017717 | |
| Ipilimumab/Nivolumab | Yevroy/Opdivo | I | 42 | Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma | NCT02311920 | ||
| LAG-3/4-1BB/PD-1 | BMS-986016/Urelumab/Nivolumab | n/a, n/a, Opdivo | I | 68 | Anti-LAG-3 or Urelumab Alone and in Combination With Nivolumab in Treating Patients With Recurrent Glioblastoma | NCT02658981 | |
| Merck | PD-L1 | Pembrolizumab | Keytruda | I | 42 | Hypofractionated Stereotactic Irradiation (HFSRT)With Pembrolizumab and Bevacizumab for Recurrent HighGrade Gliomas | NCT02313272 |
| Pembrolizumab | Keytruda | 12 | Pembrolizumab (MK-3475) in Patients With RecurrentMalignant Glioma With a Hypermutator Phenotype | NCT02658279 | |||
| Pembrolizumab | Keytruda | I/II | 52 | MK-3475 in Combination With MRI-guided Laser Ablation in Recurrent Malignant Gliomas | NCT02311582 | ||
| Pembrolizumab | Keytruda | 75 | Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, or Hypermutated Brain Tumors | NCT02359565 | |||
| Pembrolizumab | Keytruda | II | 108 | Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) | NCT03018288 | ||
| Pembrolizumab | Keytruda | II | 48 | Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects (CAPTIVE) | NCT02798406 | ||
| Pembrolizumab | Keytruda | II | 20 | Pharmacodynamic Study of Pembrolizumab in Patients With Recurrent Glioblastoma | NCT02337686 | ||
| Pembrolizumab | Keytruda | II | 82 | Pembrolizumab +/− Bevacizumab for Recurrent GBM | NCT02337491 | ||
| Pembrolizumab | Keytruda | 30 | A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma | NCT02852655 | |||
| Pembrolizumab | Keytruda | I/II | 50 | Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma | NCT02530502 | ||
| Pembrolizumab | Keytruda | I/II | 58 | Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475 | NCT02430363 | ||
| Pfizer | PD-L1 | Avelumab | n/a | II | 43 | Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma | NCT02968940 |
| AZ | PD-L1 | Durvalumab | n/a | II | 159 | Phase 2 Study of MEDI4736 in Patients With Glioblastoma | NCT02336165 |
| PD-L1 | Durvalumab | n/a | I/II | 62 | A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma (STERIMGLI) | NCT02866747 | |
| CTLA-4/PD-L1 | Tremelimumab/Durvalumab | n/a | II | 36 | Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma | NCT02794883 |
Abbreviations: BMS, Bristol Myers Squibb; AZ, Astra Zeneca; CTLA4, cytotoxic T-lymphocyte antigen-4; PD-1, programmed cell death protein 1; PD-L1, probrammed cell death 1 ligand 1; LAG-3, lymphocyte activation gene 3.