Table 3.
Ongoing clinical trials incorporating experimental drugs for GBM treatment
| ClinicalTrials.gov ID (other ID) | Experimental treatment | Condition | Control or comparator treatment | Sponsor | Patients, n | Study Phase | Primary outcome measures |
|---|---|---|---|---|---|---|---|
| Drugs targeting growth factor receptors | |||||||
| NCT02573324 (Intellance 1) | ABT‐414, RT and TMZ | Newly diagnosed | Placebo, RT and TMZ | Abbvie | 640 | Phase II/III | OS |
| NCT02343406 (INTELLANCE 2) | ABT‐414 alone or ABT‐414 + TMZ | Recurrent | Lomustine alone or TMZ alone | Abbvie | 260 | Phase II | Cmax, PFS, OS, AUC and others |
| NCT03296696 | AMG 596 | Recurrent, newly diagnosed | – | Amgen | 82 | Phase I | N subject with adverse events |
| NCT03618667 | GC1118 | Recurrent | – | Samsung Medical Center | 23 | Phase II | PFS6 |
| NCT03603379 | C225‐ILs‐dox | Recurrent | – | University Hospital, Basel, Switzerland | 9 | Phase I | Ratio of C225‐ILs‐dox concentration |
| NCT03231501 | HMPL‐813 (epitinib) | NA | – | Hutchison Medipharma Limited | 29 | Phase I | ORR |
| NCT03631836 (MARELLE01) | GS5745 | Recurrent | – | Assistance Publique Hopitaux De Marseille | 34 | Phase I | DLT |
| NCT01903330 | ERC1671/GM‐CSF/Cyclophosphamide + bevacizumab | Recurrent | Placebo injection/placebo pill + bevacizumab | Daniela A. Bota | 84 | Phase II | Safety |
| NCT03722342 | TTAC‐0001 and pembrolizumab | Recurrent | – | PharmAbcine | 20 | Phase I | DLT, AE, ADA |
| NCT03856099 | TTAC‐0001 | Recurrent | 36 | Phase II | AE | ||
| Drugs targeting DNA repair and cell cycle control pathways | |||||||
| NCT03107780 | AMG‐232 | Recurrent, newly diagnosed | – | National Cancer Institute | 86 | Phase I | PK, MTD |
| NCT02345824 | LEE011 (ribociclib) | Recurrent | – | University of Virginia | 3 | Phase I | Inhibition of CDK4/CDK6 signaling pathway in cell proliferation |
| NCT02255461 | PD‐0332991 (palbociclib isethionate) | Recurrent | – | Pediatric Brain Tumor Consortium | 35 | Phase I | MTD, AE |
| NCT03581292 | ABT‐888 (veliparib), RT and TMZ | Newly diagnosed | – | National Cancer Institute | 115 | Phase II | EFS |
| NCT02152982 | TMZ and veliparib | Newly diagnosed | TMZ and placebo | National Cancer Institute | 440 | Phase II/III | OS |
| NCT01514201 | Veliparib, TMZ, 3D‐CRT, IMRT | Newly diagnosed | – | National Cancer Institute | 66 | Phase I/II | MTD, feasibility, OS |
| NCT03233204 | Olaparib | NA | National Cancer Institute | 49 | Phase II | ORR | |
| NCT01390571 | Olaparib + TMZ | Recurrent | – | Cancer Research UK | 34 | Phase I | Detection of olaparib in tumor tissue, MTD, toxicity profile, DLT |
| PARADIGM‐2 | Olaparib + RT + TMZ (methylated MGMT) or olaparib + RT (unmethylated MGMT) | Newly diagnosed | – | Cancer Research UK | 68 | Phase I | |
| NCT03212742 | Olaparib + TMZ+ IMRT | NA | – | Centre Francois Baclesse | 79 | Phase I/II | RP2D |
| NCT02974621 | Olaparib + cediranib maleate | Recurrent | Bevacizumab | National Cancer Institute | 70 | Phase II | PFS6 |
| Drugs targeting epigenetics and tumor metabolism | |||||||
| NCT02073994 | AG‐120 (veliparib) | NA | – | Agios Pharmaceuticals, Inc. | 170 | Phase I | AE, MTD, RP2D |
| NCT02481154 | AG‐881 (vorasidenib) | NA | – | Agios Pharmaceuticals, Inc. | 150 | Phase I | AE, MTD, RP2D |
| NCT02273739 | AG‐221 (enasidenib) | NA | – | Celgene | 21 | Phase I/II | AE, MTD, RP2D |
| NCT02381886 | IDH305 | NA | – | Novartis Pharmaceuticals | 166 | Phase I | DLT |
| NCT03030066 | DS‐1001b | NA | – | Daiichi Sankyo Co., Ltd. | 60 | Not Applicable | % of patients with DLT |
| NCT02746081 | BAY1436032 | NA | – | Bayer | 81 | Phase I | AE, MTD, RP2D |
| NCT02454634 | IDH peptide vaccine | National Center for Tumor Diseases, Heidelberg | 39 | Phase I | Safety, tolerability, immunogenicity | ||
| NCT03426891 | Pembrolizumab + vorinostat + TMZ + RT | Newly diagnosed | – | H. Lee Moffitt Cancer Center and Research Institute | 32 | Phase I | MTD |
| NCT00731731 | RT + vorinostat + TMZ | Newly diagnosed | – | National Cancer Institute | 125 | Phase I/II | MTD, OS |
| NCT00268385 | Vorinostat + TMZ | NA | – | National Cancer Institute | 83 | Phase I | MTD |
| NCT00555399 | Vorinostat + isotretinoin/TMZ+ isotretinoin/vorinostat +isotretinoin + TMZ | Recurrent | – | M.D. Anderson Cancer Center | 135 | Phase I/II | MTD |
| Drugs targeting angiogenesis | |||||||
| NCT01290939 | Lomustine + bevacizumab | Recurrent | Lomustine | European Organisation for Research and Treatment of Cancer | 433 | Phase III | OS |
| NCT03025893 (STELLAR) | Sunutinib | Recurrent | Lomustine | VU University Medical Center | 100 | Phase II/III | PFS6 |
| NCT01931098 | Topotecan + pazopanib | Recurrent | – | National Cancer Institute | 35 | Phase II | PFS6, PFS3 |
| Immunotherapies | |||||||
| NCT02078648 | SL‐701 + poly‐ICLC + bevacizumab | Recurrent | – | Stemline Therapeutics, Inc. | 74 | Phase I/II | Safety, tolerability, OS12, ORR |
| NCT02844062 | Anti‐EGFRvIII CAR T cells | Recurrent | – | Beijing Sanbo Brain Hospital | 20 | Phase I | Safety |
| NCT02649582 (ADDIT‐GLIO) | Dendritic cell vaccine + TMZ | NA | – | University Hospital, Antwerp | 20 | Phase I/II | OS |
| NCT02798406 | DNX‐2401 + pembrolizumab | NA | – | DNAtrix, Inc. | 49 | Phase II | ORR |
| NCT03043391 | Polio/Rhinovirus Recombinant (PVSRIPO) | Recurrent | – | Istari Oncology, Inc. | 12 | Phase I | Percentage of participants with unacceptable toxicity |
| NCT02414165 | Toca 511/Toca FC | Recurrent | Lomustine, TMZ or Bevacizumab | Tocagen Inc. | 403 | Phase II/III | OS |
| NCT02550249 (Neo‐nivo) | Nivolumab | Newly diagnosed and recurrent | Nivolumab | Clínica Universidad de Navarra | 29 | Phase II | Expression of PDL‐1 |
| NCT02336165 | MEDI4736 alone or MEDI4736 + bevacizumab or MEDI4736 + RT | Newly diagnosed and recurrent | – | Ludwig Institute for Cancer Research | 159 | Phase II | OS, PFS6 |
| NCT03174197 | Atezolizumab + TMZ or atezolizumab + TMZ + RT | Newly diagnosed | – | M.D. Anderson Cancer Center | 60 | Phase I/II | DLT, OS, AE |
ADA: anti‐drug antibody; AE: adverse events; AUC: area under the curve; DLT: dose limiting toxicity; EFS: event‐free survival; IMRT: intensity modulated radiation therapy; MTD: maximum tolerated dose; NA: not available; ORR: objective response rate; OS: overall survival; OS12: overall survival at 12 months; PFS: progression‐free survival; PFS3: progression‐free survival at 3 months; PFS6: progression‐free survival at 6 months; PK: pharmacokinetics; poly‐ICLC: polyinosinic–polycytidylic acid stabilized with polylysine and carboxymethyl cellulose; RP2D: recommended phase II dose; RT: radiation therapy