Disease Type | Agent (Trade name, Sponsors) | Description | Tumor Type | Study Design/ Endpoints |
NY-ESO-1 expressing tumors (esophageal, gastric, HCC, colorectal) | DEC-205-NY- ESO-1 fusion protein vaccine | mTOR inhibition with rapamycin for enhancing intranodal dendritic cell vaccine induced anti-tumor immunity in patients with NY-ESO-1 expressing solid tumors | NY-ESO-1 expressing tumors following resection including esophageal, gastric, HCC and colorectal carcinomas (NCT01522820) | Non-randomized phase I study of DEC-205-NY-ESO-1 fusion protein vaccine in combination with mTOR inhibitor sirolimus in NY-ESO-1 expressing tumors following resection Primary: Safety Secondary: NY-ESO-1 specific cellular and humoral immunity |
Esophageal | K562-GM tumor cell vaccine | Allogeneic K562-GM tumor cell vaccine expressing cancer testis antigens | Resected high-risk thoracic malignancies (including esophageal) expressing cancer testis antigens (NCT01143545) | Non-randomized phase I/II study of K562-GM tumor cell vaccine in combination with metronomic oral cyclophosphamide and celecoxib Primary: Safety Secondary: Induction of immunity; reduction of T-regulatory cells in peripheral blood |
H1299 cell lysate/Iscomatrix vaccine | Allogeneic H1299 cell lysate/Iscomatrix vaccine expressing cancer testis antigens | Resected high-risk thoracic malignancies (including esophageal) expressing cancer testis antigens (NCT02054104) | Randomized phase I/II study of H1299 cell lysate/Iscomatrix vaccine with or without the combination with metronomic oral cyclophosphamide and celecoxib Primary: Immune response rates Secondary: Immune response rates | |
Gastric | AVX901 | Recombinant Venezuelan equine encephalitis (VEE) alphavirus packaged in virus-like replicon particles (VRP) expressing HER2 | Metastatic HER2 positive cancers including gastric adenocarcinoma (NCT01227772) | Non-randomized phase I study of AVX901 vaccine Primary: Safety Secondary: Induction of HER2 specific immunity |
OTSGC-A24 | Allogeneic cell vaccine expressing tumor specific antigensand VEGFR1 HLA-A24 epitopes | Metastatic gastric adenocarcinoma (NCT01526473) | Non-randomized phase I/IIa study of OTSGC-A24 vaccine Primary: Safety Secondary: Induction of T-effector specific immunity | |
Pancreatic Cancer | Algenpantucel-L (HyperAcute®, NewLink Genetics Corporation) | Allogeneic whole pancreatic cells expressing α-galactosyl (αGal) epitopes that elicit complement-mediated lysis and antibody-dependent cell-mediated toxicity | Resected high-risk pancreatic carcinoma (NCT01072981) | Randomized open-label phase III trial of algenpantucel-L gemcitabine with or without 5-flurouracil (5FU) chemoradiation vs. gemcitabine with or without 5FU chemoradiation alone Primary: OS Secondary: DFS |
Borderline resectable or locally advanced unresectable pancreatic carcinoma (NCT01836432) | Randomized open-label phase III trial of algenpantucel-L with FOLFIRINOX vs. FOLFIRINOX alone Primary: OS Secondary: PFS, immune response |