Table 3 Ongoing clinical trials investigating combination regimens incorporating systemic therapies and immune checkpoint inhibitors in pancreatic cancer
Study/phase | n (patients needed) | Setting | Regimen | Primary outcome |
|---|---|---|---|---|
NCT02648282/phase II | 54 | Locally advanced | CY + GVAX + PD-1 + SBRT | Distant metastasis free survival |
NCT02451982/phase I/II | 50 | Neoadjuvant/adjuvant | CY/GVAX vs. CY/GVAX + nivolumab | Median IL17A expression |
NCT03190265/phase II | 63 | Metastatic | Nivolumab/ipilimumab/CRS-207 + CY/GVAX vs. Nivolumab/ipilimumab/CRS-207 | ORR |
NCT03168139/phase I/II | 20 | Metastatic | Olaptesed pegol + pembrolizumab | Pharmacodynamics + safety |
NCT03161379/phase II | 50 | Neoadjuvant | CY/GVAX + nivolumab + SBRT | Pathologic complete response |
NCT03006302/phase II | 70 | Metastatic | Epacadostat/pembrolizumab/CRS-207 + CY/GVAX vs. Epacadostat/pembrolizumab/CRS-207 | Recommended Dose of Epacadostat + 6 Month Survival |
NCT03481920/phase I | 24 | Locally advanced/metastatic | Pegylated Hyaluronidase + avelumab | ORR + safety |
NCT02734160/phase I | 37 | Metastatic | Galunisertib + durvalumab | DLT |
NCT02983578/phase II | 75 | Locally advanced/metastatic | AZD9150 (antisense STAT3) + durvalumab | Disease Control Rate |
NCT03451773/phase Ib/II | 41 | Locally advanced/metastatic | M7824 (TGF-beta + PD-L1 inhibitor) + gemcitabine | Safety and tolerability |
NCT02403271/phase Ib/II | 124 | Locally advanced/metastatic | Ibrutinib + durvalumab | ORR + safety and tolerability |
NCT01896869/phase II | 92 | Metastatic | Ipilimumab + vaccine vs. FOLFIRINOX | OS |
NCT02451982/phase I/II | 50 | Neoadjuvant/adjuvant | CY (day 0) + GVAX (day 1 and 6–10 days after surgery ×4 + adjuvant CRT vs. CY (day 0) + GVAX (day 1 and 6–10 weeks after surgery ×4 + nivolumab (day 0 and 6–10 weeks after surgery) | Median IL17A expression |
NCT02548169/phase I | 20 | Neoadjuvant | Arm A: Dendritic cell vaccine + standard of care chemotherapy Arm B: Dendritic cell vaccine + standard of care chemotherapy in metastatic disease | Safety and feasibility |
NCT02243371/phase II | 96 | Metastatic | Arm A: CRS-207 + GVAX + nivolumab Arm B: CRS-207 + GVAX | OS |
NCT02268825/phase I | 39 | Locally advanced/metastatic | Pembrolizumab + FOLFOX | Safety |
NCT02303990/phase I | 70 | Locally advanced/metastatic | Pembrolizumab + RT | Adverse events |
NCT02930902/phase Ib | 30 | Neoadjuvant | Pembrolizumab + paricalcitol vs. pembrolizumab + paricalcitol & standard chemo | Toxicity profile, Number of Tumor Infiltrating Lymphocytes |
NCT03264404/phase II | 31 | Locally advanced/metastatic | Pembrolizumab + azacitadine | PFS |
NCT02907099/phase II | 15 | Metastatic | BL-8040 + pembrolizumab | ORR |
NCT02648282/phase II | 54 | Locally advanced | CY + GVAX + pembrolizumab + SBRT | Distant Metastasis Free Survival |
NCT02546531/phase I | 50 | Locally advanced | Dose escalation and expansion: defactinib + pembrolizumab + gemcitabine | Recommended phase II dose |
NCT02758587Phase I/II | 59 | Locally advanced | Defactinib + pembrolizumab | Adverse events |
NCT03519308/phase I | 20 | Perioperative | nivolumab + nab-paclitaxel + gemcitabine + paricalcitol vs. nivolumab vs. nab-paclitaxel vs. gemcitabine | Adverse events |
NCT03336216/phase II | 160 | Locally advanced/metastatic | Arm A: Gemcitabine/nab-paclitaxel or 5-fluorouracil/leucovorin/irinotecan Arm B: Cabiralizumab and nivolumab Arm C: cabiralizumab/nivolumab + gemcitabine/abraxane Arm D: cabiralizumab/nivolumab + oxaliplatin/5- fluorouracil/leucovorin | PFS |
NCT03104439/phase II | 80 | MSI/MSS | Nivolumab + ipilimumab + RT | Disease control rate |
NCT03214250/phase Ib/II | 105 | Metastatic | Arm A: Gemcitabine + nab-paclitaxel + nivolumab Arm B: Gemcitabine + nab-paclitaxel + APX005M (CD40 agonistic monoclonal antibody) Arm C: Gemcitabine + nab-paclitaxel + nivolumab + APX005 M | Adverse events, OS |
NCT03404960/phase 1b/II | 84 | Locally advanced/metastatic | Niraparib + nivolumab | PFS |
NCT03184870/phase I/II | 260 | Metastatic | Arm A: BMS-813160 + 5-fluorouracil (5-FU) + leucovorin + irinotecan Arm B: BMS-813160 + nab/paclitaxel + gemcitabine Arm C: BMS-813160 + nivolumab Arm D: BMS-813160 | Adverse events, death, ORR, PFS |
NCT03250273/phase II | 54 | Metastatic | Entinostat + nivolumab | ORR |
NCT02754726/phase II | 10 | Metastatic | Nivolumab + paclitaxel + paricalcitol + cisplatin + gemcitabine | Complete response rate |
NCT03373188/phase I | 32 | Neoadjuvant | Arm A: surgery only Arm B: VX15/2503 (anti-SEMA4D monoclonal antibody) + surgery Arm C: VX15/2503 + ipilimumab + surgery Arm D: VX15/2503 + nivolumab + surgery | Tumor CD8 + T cell infiltration between treatment groups |
NCT03098550/phase I/II | 120 | Locally advanced/metastatic | Nivolumab + daratumumab | Tolerability |
NCT02777710/phase I | 58 | Locally advanced/metastatic | Pexidartinib + durvalumab | Dose limiting toxicities, ORR |
NCT02866383/phase II | 80 | Metastatic | Arm A: Nivolumab + RT Arm B: Nivolumab + ipilimumab + RT | Clinical benefit rate |
NCT03098160/phase I | 69 | Locally advanced/metastatic | Evofosfamide + Ipilimumab | Recommended phase II dose |
NCT02879318/phase II | 180 | Metastatic | Arm A: Gemcitabine + nab-paclitaxel Arm B: Gemcitabine + nab-paclitaxel + durvalumab + tremelimumab | OS |
NCT02658214/phase Ib | 42 | Locally advanced/metastatic | Durvalumab + tremelimumab + nab-paclitaxel + gemcitabine | Adverse events, tumor assessment, laboratory findings |