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