Table 2.
Published clinical trials of immune checkpoint inhibitors alone or in combination therapy.
| Phase of Trial | Therapy | No of Patients | Setting | Median PFS/OS (Months) | Response | Reference |
|---|---|---|---|---|---|---|
| II | Ipilimumab | 27 | Locally advanced/metastatic 74% pretreated | OS: 4.5 | 0% RR 1 delayed response |
[130] |
| I | BMS-936559 | 14 | Advanced Pre-treated |
NR | 0% RR | [70] |
| II randomized | Durvalumab vs. Durvalumab + tremelimumab | 33 32 |
Metastatic 2nd-line |
OS: 3.6 OS: 3.1 |
6% DCR 9% DCR 3% PR |
[131] |
| Pilot study | Durvalumab Durvalumab + tremelimumab + SBRT |
24 | Metastatic Pre-treated |
NR | 21% SD | [132] |
| II (safety profile) |
Durvalumab + tremelimumab + gemcitabine + nab-paclitaxel | 11 | Metastatic No prior treatment |
PFS:7.9 | 73% PR 100% DCR |
[133] |
| Ib/II randomized | Pembrolizumab + capecitabine + RT vs. Capecitabine + RT |
14 8 |
Neoadjuvant: 50% resectable/50% borderline resectable |
NR | 71% underwent surgery 50% underwent surgery |
[134] |
| Ib dose escalation | Gemcitabine-> tremelimumab (different doses) | 34 | Metastatic No prior treatment |
OS: 7.4 | 21% SD 6% PR |
[135] |
| Ib | Ipilimumab + gemcitabine | 16 | Advanced No prior gemcitabine in advanced setting |
PFS: 2.5 OS: 8.5 |
13% PR 31% SD |
[136] |
| Ib/II | Pembrolizumab + gemcitabine + nab-paclitaxel | 12 5 |
Metastatic No prior treatment Pre-treated |
PFS: 9.1 OS: 15.0 NR |
25% PR 67% SD 40% SD |
[137] |
| II | Pembrolizumab + reolysin + 5-FU Pemrolizumab + reolysin + gemcitabine Pembrolizumab + reolysin + irinotecan |
11 | Metastatic 2nd line | NR | 9% PR 18% SD |
[138] |
| I | Nivolumab + nab-paclitaxel + gemcitabine | 50 | Locally advanced/metastatic No prior treatment PD-L1 expression ≥ 1%: 24% PD-L1 expression ≥: 12% |
PFS: 5.5 OS: 9.9 |
2% CR 16% PR 46% SD |
[139] |
| II, pilot | Nivolumab + nab-paclitaxel + gemcitabine + paricalcitol | 10 | Metastatic 1st line | PFS: 8.2 | 80% PR 100% DCR |
[140] |
| Ib | Gemcitabine + nab-paclitaxel + APX005M (anti-CD40 antibody) ± nivolumab | 30 | Metastatic No prior treatment |
NR | 47% PR 27% SD |
[141] |
| I Dose escalation |
Gemcitabine Gemcitabine + 0.5 mg IMP321 Gemcitabine + 2.0 mg IMP321 |
6 6 5 |
Advanced 1st line | OS: 16.7 TTP: 10.2 OS: 5.6 TTP: 2.0 OS: 6.4 TTP: 5.3 |
83% SD 33% SD 60% SD |
[142] |
| Ib randomized | Ipilimumab vs. Ipilimumab + vaccine |
15 15 |
Advanced/metastatic Pre-treated |
OS: 3.6 OS: 5.7 |
13% SD 0% SD |
[143] |
| II randomized | Acalabrutinib vs. Pembrolizumab + acalabrutinib |
26 32 |
Metastatic Pre-treated |
NR | 15% SD 9% PR 16% SD |
[144] |
| Pilot study | Nivolumab + dendritic cells | 7 | Metastatic | NR | 29% PR | [145] |
| I | Nivolumab + magamulizumab (anti-CC-chemokine receptor 4 antibody) | 15 | Advanced/metastatic | NR | 7%PR 33% SD |
[146] |
| I Dose escalation |
Nivolumab + cabiralizumab (antibody directed against CSF-1 receptor) | 31 evaluable | Advanced Pre-treated |
NR | 10% PR 3% SD |
[147] |
| I/II | Oleclumab (antibody targeting CD73) ± durvalumab | 20 | Advanced Pre-treated |
NR | 10% PR 15% SD |
[148] |
| I/II | Durvalumab + epacadostat | 15 | Advanced Pre-treated |
NR | 27% SD | [149] |
| Retrospective | pembrolizumab | 2 | dMMR | NR | 50% PR 50% SD |
[150] |
| II | pembrolizumab | 8 | Advanced Pre-treated dMMR/MSI positive |
NR | 25% CR 37% PR 12% SD |
[151] |
| Retrospective | PD-L1 inhibitor + IDO1 (amino acid degrading enzyme) inhibitor or PD-1 inhibitor | 7 | Advanced Pre-treated dMMR |
NR | 14% CR 29% PR 14% SD |
[152] |