Tumor microenvironment in pancreatic ductal adenocarcinoma: Implications in immunotherapy

Table 2 Complete vaccine immunotherapy-based clinical trials in pancreatic ductal adenocarcinoma

Treatment	Phase	Number	Cancer stage	Outcomes
GVAX, 5-FU, chemoradiation	II	NCT00084383	Resected stage I/II PDAC	Median OS 24.8 mo (95%CI: 21.2-31.6 mo)
GVAX, cyclophosphamide, CRS-207	II	NCT01417000	Metastatic PDAC	Cy/GVAX and CRS-207 extended OS for PDAC patients, with minimal toxicity
GVAX, cyclophosphamide, CRS-207	II	NCT02004262	Metastatic PDAC	Cy/GVAX and CRS-207 did not show survival benefit over chemotherapy in patients with previously treated metastatic PDAC
GVAX, Ipilimumab, FOLFIRINOX	II	NCT01896869	Metastatic PDAC	Ipilimumab + GVAX group did not show survival benefit over chemotherapy [median OS 9.38 mo (95% CI, 5.0-12.2 mo) vs 14.7 mo (95%CI: 11.6-20.0 mo)]
Algenpantucel-L	II	NCT00569387	Surgically resected PDAC	The addition of algenpantucel-L to standard adjuvant therapy for resected pancreatic cancer may improve survival (12-mo DFS 62%, 12-mo OS 86%)
Gemcitabine, 5FU Chemoradiation, Algenpantucel-L	III	NCT01072981	Surgically Resected PDAC	No results reported yet
Dendritic cells pulsed with MUC-1/WT-1	I/II	NCT03114631	PDAC	Dendritic cells immunotherapy provided a favorable outcome in PDAC patents (12-mo OS 78.2% vs 33.8%)
GI-4000 (KRAS), Gemcitabine	II	NCT00300950	Non-metastatic, Post-resection PDAC	Overall, GI-4000 group showed a similar pattern of recurrence-free survival and OS compared with the placebo group. For stratified R1 resection subgroup, there was a trend in 1 year OS (72% vs 56%), an improvement in OS (523.5 vs 443.5 d (hazard ratio: 1.06; 95%CI: 0.53–2.13, P = 0.872), and increased frequency of immune responders (40% vs 8%; P = 0.062) for GI-4000 vs placebo.
Ras-peptide vaccine, IL-2, GM-CSF	II	NCT00019331	Metastatic PDAC	No results reported yet
GV1001 (telomerase peptide vaccine), Gemcitabine, Capecitabine	III	NCT00425360	Locally Advanced or Metastatic PDAC	Adding GV1001 vaccination to chemotherapy did not improve OS.

https://clinicaltrials.gov/. PDAC: Pancreatic ductal adenocarcinoma; Cy: cyclophosphamide; DFS: Disease-free survival; OS: Overall survival.