Table 2.
Reported and ongoing trials of targeted agents in nonmuscle-invasive bladder cancer
| Table 2a. Reported trials of targeted agents in NMIBC | |||||||
|---|---|---|---|---|---|---|---|
| Author | Year | Agent | Target | Intravesical therapy | Study type | n | RR % |
| Kowalski [15] | 2010 | Oportuzumab monatox | EpCAM | None | Phase I | 64 | NR |
| Hendricksen [12] | 2012 | Apaziquone | Mitomycin-C analogue, apoptosis | Apaziquone | Phase II | 53 | NR |
| Falke [14■■] | 2012 | TMX-101 | TLR-7 | None | Phase I | 16 | NR |
| Kowalski [13] | 2012 | Oportuzumab monatox | EpCAM | None | Two-arm, phase II | 46 | 44 |
| Table 2b. Ongoing trials of targeted agents in nonmuscle-invasive bladder cancer | |||||||
| PI | Start year | Agent | Target | Intravesicaltherapy | Study type | Target enrollment | Clinicaltrials.gov ID |
| Lamm [17] | 2008 | DTA-H19/PEI | DNA plasmid, DT-A gene, H19 transcription factors | None | Phase IIb intermediate risk with prior intravesical induction | 47 | NCT00595088 |
| Weizer [18] | 2009 | Sunitinib | VEGFR-1/2, C-KIT, PDGFR a/b, FLT3, RET | BCG | Phase II high grade | 36 | NCT00794950 |
| Dalbagni [19] | 2010 | Everolimus | PI3K/Akt/mTOR | Gemcitabine | Phase I/II BCG failure | 45 | NCT01259063 |
| Fishman [20] | 2011 | Lenalidomide | Apoptosis, antiangiogenesis, and immune modulation | BCG | Phase II with prior BCG induction | 70 | NCT01373294 |
| Fishman [16] | 2011 | Rituximab | CD20 | BCG | Phase II high grade | 70 | NCT01373294 |
| Sun [21] | 2011 | Apaziquone | Mitomycin-C analogue, apoptosis | None | Randomized phase III low risk | 658 | NCT01469221 |
| Dinney [22] | 2012 | rAD-IFN/Syn3 | Antiangiogenesis and immune modulation | None | Randomized phase II high-grade BCG failure | 40 | NCT01687244 |
| Rosser [23] | 2012 | ALT-801 | p53 | Gemcitabine | Phase Ib/II BCG failure | 52 | NCT01625260 |
| Jichlinski [24] | 2012 | recMAGE-A3+AS-15 | MAGE-A3 vaccine | BCG | Phase I high grade | 24 | NCT01498172 |
| Shapiro [25] | 2012 | Valproic acid | Thrombospondin-1 | BCG/MMC | Phase 0 | 50 | NCT01738815 |
| Lamm [26] | 2013 | TMX-101 | TLR-7 | None | Phase II with CIS | 12 | NCT01731652 |
| Hahn [27] | 2013 | Dovitinib | FGFR3 | None | Phase II BCG failure with FGFR3 mutation overexpression | 50 | NCT01732107 |
| Steinberg [28] | 2013 | HS-410 | gp96-chaperoned peptides | BCG | Phase I/II high grade with prior BCG induction phase I/II high grade with prior BCG induction | 93 | NCT02010203 |
| Agarwal [29] | 2013 | PANVAC | MUC-1, CEA | BCG | Randomized phase II BCG failure | 54 | NCT02015104 |
BCG, Bacillus Calmette-Guerin; CIS, carcinoma in situ; EpCAM, epithelial cell adhesion molecule; FGFR, fibroblast growth factor receptor; MMC, mitomycin C; mTOR, mammalian target of rapamycin; n, number of patients enrolled; NR, not reported; PDGFR, platelet-derived growth factor receptor; PI, principal investigator; RR, response rate; TLR, toll-like receptor; VEGFR, vascular endothelial growth factor receptor.