Table 3.
Ongoing randomized phase 3 trials evaluating investigational agents in glioblastoma
| ClinicalTrials.gov Identifier | Population | Treatment arms | Primary endpoint | Statusa | Sponsor |
|---|---|---|---|---|---|
| Newly diagnosed glioblastoma | |||||
| NCT00045968 | Sufficient tumor lysate after surgery | Experimental: RT/TMZ followed by TMZ + DCVax-L (dendritic cells vaccine) | PFS | Accrual suspended | Northwest Biotherapeutics |
| Comparator: RT/TMZ followed by TMZ + placebo | |||||
| NCT02617589 | Unmethylated MGMT promoter | Experimental: RT + nivolumab (anti-PD1 MAb) | OS | Recruiting | Bristol-Myers Squibb |
| Comparator: RT/TMZ followed by TMZ | |||||
| NCT02546102 | HLA-A2 positive patients | Experimental: RT/TMZ followed by TMZ + ICT-107 (dendritic cells vaccine) | OS | Recruiting | ImmunoCellular Therapeutics |
| Comparator: RT/TMZ followed by TMZ + placebo | |||||
| NCT02573324 | EGFR-amplified | Experimental: RT/TMZ/ABT-414 followed by TMZ + ABT-414 (anti-EGFR ADC) | OS | Recruiting | AbbVie |
| Comparator: RT/TMZ/placebo followed by TMZ + placebo | |||||
| NCT02152982 | Unmethylated MGMT promoter | Experimental: RT/TMZ + followed by TMZ + veliparib (PARP inhibitor) | OS | Not yet recruiting | National Cancer Institute |
| Comparator: RT/TMZ followed by TMZ + placebo | |||||
| Recurrent glioblastoma | |||||
| NCT0201771 | First progression | Experimental: nivolumab (anti-PD1 MAb) | OS | Accrual completed | Bristol-Myers Squibb |
| Comparator: bevacizumab | |||||
| NCT02511405 | First or second progression | Experimental: bevacizumab + VB-111 (viral toxin) | OS | Recruiting | Vascular Biogenics |
| Comparator: bevacizumab | |||||
| NCT02414165 | First or second progression, candidate for resection | Experimental: TOCA-511 (viral gene therapy injected in tumor resection cavity) + TOCA-FC (5-fluorocytosine) | OS | Recruiting | Tocagen |
| Comparator: Investigator's choice (single agent lomustine or temozolomide or bevacizumab) | |||||
a
Source: clinicaltrials.gov (November 2016).