| Disease Type | Agent(s) | Description | Tumor Type | Study Design/ Endpoints | Dose and Schedule |
| Pancreatic | Ipilimumab + Gemcitabine | Ipilimumab – CTLA-4 inhibitor | Recurrent/metastatic pancreatic carcinoma (NCT01473940) | Non-randomized open-label phase I study Primary: Safety (MTD), toxicity Secondary: RR, irRC, TTP, PFS, OS | Ipilimumab • IV ipilimumab q3 weeks for 4 doses (induction) then q12 weeks till progression (maintenance) Gemcitabine • IV gemcitabine qweekly (weeks 1 - 7, 9 - 11), then weekly |
| FOLFIRINOX + ipilimumab vs. FOLFIRINOX + vaccine | FOLFIRINOX – standard of care chemotherapy for pancreatic carcinoma Ipilimumab – CTLA-4 inhibitor Vaccine-allogenic GM-CSF transfected pancreatic tumor vaccine | Recurrent/metastatic pancreatic carcinoma (NCT01896869) | Randomized open-label phase II study Primary: OS Secondary: PFS, irPFS | Ipilimumab • IV ipilimumab 10 mg/kg q3 weeks for 4 doses FOLFIRINOX q2 weeks: • IV oxaliplatin 85 mg/m2 D1 • IV irinotecan 180 mg/m2 D1 • IV leucovorin 400 mg/m2 D1 • IV 5-FU 400 mg/m2 bolus then 2400 mg/m2 over 46 hrs D1-2 Allogenic GM-CSF transfected pancreatic tumor vaccine • 6 intra-dermal immunizations of 300 million immunotherapy cells days 1, 8, 15, 29, 43 and 57 • Additional 12 intra-dermal immunizations on days 1 and 15 (of 4 week cycles) in patients with distant disease for up to 18 total doses | |
| Hepatocellular | Nivolumab | Nivolumab – PD-1 inhibitor | Advanced hepatocellular carcinoma (NCT01658878) | Non-randomized open-label phase I study in 3 cohorts (non-infected, HCV-infected, HBV-infected) Primary: Safety/toxicity Secondary: ORR, DCR, PK | IV nivolumab (0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg) q2 weeks till progression |
| Colorectal | Ipilimumab + Nivolumab | Ipilimumab – CTLA-4 inhibitor Nivolumab – PD-1 inhibitor | Recurrent/metastatic microsatellite high (MSI-H) colorectal carcinoma (NCT01928394, CheckMate 142) | Non-randomized open-label phase I/II study Primary: OS Secondary: DFS | Dose level -1 • IV nivolumab 0.3 mg/kg + IV ipilimumab 1 mg/kg q3 weeks for 4 doses then IV nivolumab 0.3 mg/kg q2 weeks till progression Dose level 1 • IV nivolumab 1 mg/kg + IV ipilimumab 1 mg/kg q3 weeks for 4 doses then IV nivolumab 1 mg/kg q2 weeks till progression Dose level 2a • IV nivolumab 1 mg/kg +IV ipilimumab 3 mg/kg q3 weeks for 4 doses then IV nivolumab 1 mg/kg q2 weeks till progression Dose level 2b • IV nivolumab 3 mg/kg + IV ipilimumab 1 mg/kg q3 weeks for 4 doses then IV nivolumab 3 mg/kg q2 weeks till progression |