| Pancreatic Cancer | GVAX + CRS-207 | CRS-207-attenuated Listeria monocytogenes genetically engineered to elicit immune responses against tumor-associated mesothelin GVAX – tumor cell vaccine created by harvesting allogenic cancer cells with subsequent transfection of the granulocyte macrophage-colony stimulating factor (GM-CSF) gene. Cyclophosphamide (Cy) – low-dose metronomic cyclophosphamide | Relapsed/refractory pancreatic carcinoma (ECLIPSE) (NCT02004262) | Randomized open-label phase IIB trial of vs GVAX + CRS-207 vaccination. CRS-207 vaccination alone vs. chemotherapy Primary: OS Secondary: toxicity |
| Colorectal carcinoma | GVAX + Cy + SGI-110 | SGI-110 – DNA methyltransferase inhibitor GVAX – tumor cell vaccine created by harvesting allogenic cancer cells with subsequent transfection of the granulocyte macrophage-colony stimulating factor (GM-CSF) gene. Cyclophosphamide (Cy) – low-dose metronomic cyclophosphamide | mCRC maintenance therapy (NCT01309126) | Open-label phase I trial of SGI-110 in combination with GVAX/Cy as maintenance therapy Primary: Safety/toxicity Secondary: OS, PFS, TTP |
| CEA(6D)-VRP (AVX701) | Recombinant Venezuelan equine encephalitis (VEE) alphavirus packaged in virus-like replicon particles (VRP) expressing CEA (6D) (to enhance binding to HLA-A2, and enhanced recognition by TCR) | Stage III colorectal carcinoma following completion of adjuvant 5-FU based chemotherapy (NCT01890213) | Open-label phase I trial of AVX701 Primary: Safety/toxicity Secondary: None | |
| DC vaccine | DC vaccination with autologous tumor antigen | mCRC with hepatic metastasis following resection and standard adjuvant chemotherapy (NCT01348256) | Open-label phase II trial of DC vaccination | |
| Imprime PGG and cetuximab or cetuximab alone | Imprime PGG-polysaccharide beta 1.3/1.6 glucan derived from Saccharomyces cerevi siae cell wall | Recurrent/metastatic KRAS WT CRC (PRIMUS) (NCT01309126) | Randomized open-label phase III trial of cetuximab vs. cetuximab/Imprimg PGG Primary: OS Secondary: RR, PFS | |
| Hepatocellular Cancer | COMBIG-DC | Intra-tumoral DC vaccine | Advanced HCC (NCT01974661) | Open-label phase I trial of DC vaccination Primary: Safety/tolerability Secondary: RR, tumor marker (AFP) |
| Cytokine-induced killer (CIK) cells | Ex-vivo expanded T-cells which present a mixed T/NK phenotype and have MHC-unrestricted antitumor activity | Hepatocellular carcinoma post-resection (NCT01749865) | Randomized open-label phase III trial of standard care vs. CIK Primary: Time to recurrence Secondary: DFS |