Table 4 Clinical trials of the ICIs therapy combined with other immunotherapy strategies
From: Cold and hot tumors: from molecular mechanisms to targeted therapy
Phase | ICIs Combination Therapy (immune checkpoint) | Doses | [n.treatment] | OS | PFS | Disease | Trial | Status | Ref. |
|---|---|---|---|---|---|---|---|---|---|
III | Pembrolizumab (PD-1) + Epacadostat (IDO) | epacadostat (100 mg) orally twice daily plus pembrolizumab (200 mg) intravenously every 3 weeks. | [n = 354] | 74.4% (12-month OS rate) | 23 m | Melanoma | NCT02752074 | Completed | |
Pembrolizumab (PD-1) | placebo plus pembrolizumab (200 mg) intravenously every 3 weeks. | [n = 352] | 74.1% (12-month OS rate) | 4.7 m | |||||
I | Durvalumab (PD-L1) + Pexidartinib (CSF1) | / | [n = 47] | / | / | Metastatic/Advanced Pancreatic or Colorectal Cancers | NCT02777710 | Completed | |
Ib | Pembrolizumab (PD-1) + ARRY-382 (CSF1) | ARRY-382 [starting dose 200 mg once daily (QD) orally] plus pembrolizumab [2 mg/kg intravenously (IV) every 3 weeks (Q3W)] | [n = 19] | / | / | Solid tumors | NCT02880371 | Terminated | |
I | Pembrolizumab (PD-1) + Maraviroc (CCR5) | pembrolizumab 200 mg intravenously every 21 days in combination with maraviroc 300 mg orally twice daily for a maximum total of eight cycles | [n = 20] | 9.83 m | 2.1 m | mCRC | NCT03274804 | Completed | |
II | Pembrolizumab (PD-1) + BL-8040 (CXCR4) | BL-8040 monotherapy (1.25 mg/kg) on days 1-5 of week, followed by pembrolizumab every 3 weeks (200 mg, intravenous) | [n = 37] | 3.3 m | / | mPDAC | NCT02826486 | Completed | |
IIb | Pembrolizumab (PD-1) + mRNA-4157 (V940) | mRNA-4157 was administered intramuscularly (maximum nine doses) and pembrolizumab intravenously (maximum 18 doses) in 3-week cycles | [n = 107] | / | / | Melanoma | NCT03897881 | Recruiting | |
Pembrolizumab (PD-1) | pembrolizumab intravenously (maximum 18 doses) in 3-week cycles | [n = 50] | / | / | |||||
II | Ipilimumab (CTLA-4) + Talimogene laherparepvec (T-VEC) | T-VEC was administered intratumorally in week 1 (10(6) plaque-forming units/mL), then in week 4 and every 2 weeks thereafter (10(8) plaque-forming units/mL). Ipilimumab (3 mg/kg) was administered intravenously every 3 weeks for four infusions, beginning in week 6. | [n = 98] | 54.7% (5-year OS rate) | 13.5 m | Melanoma | NCT01740297 | Completed | |
Ipilimumab (CTLA-4) | Ipilimumab (3 mg/kg) was administered intravenously every 3 weeks for four infusions, beginning in week 6. | [n = 100] | 48.4% (5-year OS rate) | 6.4 m | |||||
III | Nivolumab (PD-1) + BEMPEG (IL-2) | BEMPEG was intravenously at a dose of 0.006 mg/kg, sequentially followed by intravenous nivolumab administration at a dose of 360 mg, once every 3 weeks. | [n = 391] | 29.67 m | 4.17 m | Melanoma | NCT03635983 | Completed | |
Nivolumab (PD-1) | nivolumab monotherapy administered intravenously at a dose of 360 mg once every 3 weeks | [n = 392] | 28.88 m | 4.99 m | |||||
I/II | Nivolumab (PD-1) + BEMPEG (IL-2) | EMPEG 0.006 mg/kg plus nivolumab 360 mg intravenously every 3 wk | [n = 41] | 23.7 m | 4.1 m | Advanced/mUC | NCT02983045 | Completed | |
Ib | Pembrolizumab (PD-1) + Utomilumab (4-1BB/CD137) | Utomilumab (0.45-5.0 mg/kg) and pembrolizumab (2 mg/kg) were administered intravenously every 3 weeks. | [n = 23] | / | / | Advanced Solid Tumors | NCT02179918 | Completed | |
II | Nivolumab (PD-1) + Sotigalimab (CD40) + Chemotherapy | Nivolumab (1000 mg/m2),Sotigalimab (0.1 mg/kg), nab-paclitaxel (125 mg/m2) | [n = 35] | 41.3% (1-year OS rate) | 6.7 m | mPDAC | NCT03214250 | Completed |
