Table 1.
Clinical trials combining molecularly-targeted agents or immunotherapy with radiation in PDAC
| Class | Trial | Phase | Stage | Drug therapy | Target | Radiation | Outcomes | Reference |
|---|---|---|---|---|---|---|---|---|
| Parp | NCT01585805 | I | Unresectable | Veliparib | PARP | 36 Gy in 15 fractions | Completed | |
| Cell cycle checkpoints | NCT00047307 | I | Unresectable | Alvocidib | CDK9 | 50.4 Gy in 28 fractions | Completed | |
| NCT02037230 | II | Unresectable | MK-1775 | Wee-1 | 52.5 Gy in 25 fractions | Recruiting | ||
| Tyrosine kinase | MD Anderson | II | Locally advanced | Cetuximab | EGFR | 50.4 Gy in 28 fractions | Median OS 19.2 months (95% CI, 14.2 to 24.2 months) 1-, 2-, and 4-year actuarial overall survival rates were 66.0%, 25.02%, and 11.3% | (41) |
| Penn state | I | Locally advanced | Erlotinib | EGFR | 50.4 Gy in 28 fractions | Median OS 1.1 years (95 % CI, 0.62–1.59) | (42) | |
| Checkpoint inhibitors | NCT02868632 | Ib | Unresectable locally advanced | MEDI4736 and tremelimumab | PDL-1 and CTLA4 | SBRT 30 Gy in 5 fractions | Recruiting | |
| NCT02866383 | II | Metastatic refractory to prior chemotherapy | Nivolumab and ipilimumab | PD-1 and CTLA4 | SBRT 15 Gy in 1 fraction | Recruiting | ||
| NCT02311361 | II | Unresectable locally advanced | Durvalumab +/− tremelimumab | PD-1 and CTLA4 | SBRT 8 Gy in 1 fraction or 25 Gy in 5 fractions | Recruiting | ||
| NCT02305186 | II | Resectable or borderline resectable pancreatic cancer | Pembrolizumab | PD-1 | Neoadjuvant chemoradiation with capecitabine and radiation 50.4 Gy in 28 fractions | Prelim data: Similar toxicities. No reported grade 4 toxicities | (43), ASCO Meeting 2017 | |
| Cancer vaccine | NCT01072981 (IMPRESS) | III | Surgically resected | Algenpantucel-L | alpha-1,3-galactosyltransferase | 50.4 Gy in 28 fractions | No difference in OS between groups. Median OS 27.3 vs. 30.4 months. | |
| NCT02648282 | II | Locally advanced | GVAX +pembrolizumab | granulocyte-macrophage colony-stimulating factor | SBRT 33 Gy in 5 fractions | Recruiting | ||
| NCT02446093 | II | Borderline resectable | GMCI | AdV-tk (aglatimagene besadenovec) + valacyclovir | 50.4 Gy in 28 fractions | Recruiting | ||
| Cytokines | ACOSOG Z05031 | II | Resected | IFN-alpha | – | 50.4 Gy in 28 fractions | All-cause grade ≥3 toxicity rate was 95%. Median disease-free survival and overall survival were 14.1 months (95% CI, 11.0–20.1 months) and 5.4 months (95% CI, 23.4–34.1 months) | (44) |
| Multi-Institutional | III | Unresectable | TNFerade | TNF-alpha | 50.4 Gy in 28 fractions | No difference in median PFS and OS. PFS 6.8 vs. 7.0 months. OS 10 months in both arms | (45) |
PDAC, pancreatic ductal adenocarcinoma; EGFR, epidermal growth factor receptor.