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Table 3 Ongoing clinical trials investigating combination regimens incorporating systemic therapies and immune checkpoint inhibitors in pancreatic cancer

From: Combination systemic therapies with immune checkpoint inhibitors in pancreatic cancer: overcoming resistance to single-agent checkpoint blockade

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
  1. PD-1 programmed cell death protein 1 receptor, PD-L1 programmed death ligand 1, CTLA-4 cytotoxic T-lymphocyte associated protein 4, CY cyclophosphamide, ORR objective response rate, DLT dose-limiting toxicities, FOLFIRINOX folinic acid, 5-fluorouracil, irinotecan, and oxaliplatin, OS overall survival, GVAX GVAX, allogeneic pancreatic tumor cells transfected with granulocyte-macrophage colony-stimulating factor (GM-CSF) gene, SBRT stereotactic body radiation therapy, TGF transforming growth factor, FOLFOX 5-fluorouracil, folinic acid, and oxaliplatin, PFS progression-free survival, MSI/MSS microsatellite instability/microsatellite stable, RT radiotherapy