Table 1.
Summary of Clinical Trials targeting the TME and/or cancer cell invasive ability in PDAC.
| Pathway (Drug) | Clinical Trial Number | Trial Summary | Status | First Posted | Outcome |
|---|---|---|---|---|---|
| FAK inhibition (Defactinib) | NCT02758587 | Defactinib concurrent with PD-1 inhibition, Phase I/II | Recruiting | 2016 | No results posted |
| NCT04331041 | SBRT1 concurrent with defactinib, Phase I/II | Not yet recruiting | 2020 | ||
| NCT03727880 | Standard peri-operative chemotherapy, with PD-1 inhibition +/− defactinib, Phase II | Recruiting | 2018 | No results posted | |
| Hedgehog inhibition (GDC-0449, Vismodegib) | NCT01096732 | Preoperative administration of GDC-0449, Phase II | Terminated due to slow recruitment | 2010 | No results posted |
| NCT01088815 | GDC-0449 in combination with Gem/Abraxane, Phase II | Completed | 2010 | Addition of GDC-0449 to chemo did not improve efficacy as compared with historical rates with chemotherapy alone [175] | |
| NCT01064622 | Vismodegib with gemcitabine, Phase I/II | Completed | 2010 | Addition of vismodegib did not improve response rate, OS, or PFS [176] | |
| Hyaluronic acid (PEGPH20) | NCT03634332 | Combination PEGPH20 and PD-1 inhibitor for patients with previously treated Hyaluronan-high tumors, phase II | Recruiting | 2018 | No results posted |
| NCT03193190 | Combination PEGPH20 and PD-L1 inhibitor for previously treated patients, phase II | Recruiting | 2017 | No results posted | |
| NCT02715804 | Gem/Abraxane +/− PEGPH20 in patients with hyaluronan-high tumors, phase III | Terminated (Sponsor decision) | 2016 | PEGPH20 did not improve efficacy of Gem/Abraxane or improve outcomes [185] | |
| NCT01839487 | Gem/Abraxane +/− PEGPH20, Phase II | Completed | 2013 | Combination therapy with PEGPH20 shows improved progression-free survival (9.2 months versus 5.2 months) [180] | |
| GVAX | NCT00084383 | GVAX + adjuvant chemoradiotherapy in resected pancreatic cancer, phase II | Completed | 2004 | Improved median disease-free survival compared to historical data (17.3 months) [193] |
| NCT00727441 | GVAX +/− Cy followed by surgical resection and standard adjuvant chemoradiotherapy, phase II | Completed | 2008 | Not published | |
| NCT01896869 | Ipilimumab/GVAX vs. FOLFIRINOX, phase II | Completed | 2013 | Ipilimumab/GVAX did not improve OS over continuation of chemotherapy; however clinical responses were observed [195] | |
| NCT02004262 | Cy/GVAX + CRS-207 vs. CRS-207 vs. standard chemotherapy, phase II | Completed | 2013 | Cy/GVAX + CRS-207 did not improve survival over chemotherapy [194] | |
| NCT02243371 | Cy/GVAX/CRS-207 +/− nivolumab, phase II | Completed | 2014 | There was no difference in survival between the two arms [222] | |
| NCT02648282 | Cy/Pembrolizumab/GVAX + SBRT | Recruiting | 2016 | No results posted | |
| RAS vaccine | NCT02261714 | TG01/GM-CSF + gemcitabine, phase II | Completed | 2014 | Improved median OS and DFS (33.1 and 13.9 months) compared to historical data for gemcitabine alone [223] |
| MUC vaccine | NCT00088660 | PANVAC™-VF Vaccine + GM-CSF vs. best supportive care or palliative chemotherapy, phase III | Not recruiting | 2004 | Did not meet endpoint |
| NCT02310971 | CVac +/− chemoradiotherapy, phase II | Withdrawn (Sponsor decision) | 2014 | No results posted | |
| NCT02132403 | IMPRIME PGG® With Anti-MUC1 mAb (BTH1704) and Gemcitabine, phase I | Terminated (Drug recall) | 2014 | No results posted | |
| Kinesin (Kif20A) | UMIN000007991 | Multipeptide cocktail vaccine (OCV-C01) + gemcitabine, phase II | Completed | Favorable median disease-free survival compared to historical data (15.8 months) [211] | |
| CSF1R (Cabiralizumab) | NCT03336216 | Cabiralizumab + nivolumab/chemo | Not recruiting | 2017 | Did not meet endpoint |
| Connective Tissue Growth Factor (pamrevlumab) | NCT02210559 | Pamrevlumab + Gem/nab-paclitaxel vs. Gem/nab-paclitaxel | Not recruiting | 2014 | Patients who received Pamrevlumab were more likely to undergo resection vs. those who received chemotherapy alone [217] |