Table 7 Clinical trials of immunotherapy combined with target therapy
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. |
---|---|---|---|---|---|---|---|---|---|
I/II | Pembrolizumab (PD-1) + Enfortumab vedotin (Nectin-4) | vedotin (1.25 mg/kg) once daily on days 1 and 8 and pembrolizumab (200 mg) (day 1) intravenously once daily in 3-week cycles. | [n = 45] | / | 12.3 m | Urothelial cancer | NCT03288545 | Active, not recruiting | |
I/II | Pembrolizumab (PD-1) + Niraparib (PARP1/2) | niraparib (200) mg of oral once daily and pembrolizumab (200 mg) of intravenous on day 1 of each 21-day cycle. | [n = 62] | / | / | Ovarian carcinoma | NCT02657889 | Completed | |
III | Atezolizumab (PD-L1) + Vemurafenib (B-RAF) + Cobimetinib(MEK1) | atezolizumab (840 mg) intravenous day 1 and 15, twicedaily vemurafenib (720 mg), and once-daily cobimetinib (60 mg) 21 days on–7 days off. | [n = 256] | / | 39 m | Melanoma | NCT02908672 | Active, not recruiting | |
Vemurafenib (B-RAF) + Cobimetinib (MEK1) | placebo intravenous day 1 and 15, twicedaily vemurafenib (720 mg), and once-daily cobimetinib (60 mg) 21 days on–7 days off. | [n = 258] | / | 25.8 m | |||||
II | Atezolizumab (PD-L1) + Cobimetinib (MEK1) + Chemotherapy | Cobimetinib (60 mg QD) on days 1–21 of each 28-day cycle; paclitaxel (80 mg/m2 QW); nab-paclitaxel (100 mg/m2 QW); atezolizumab (840 mg Q2W). | [n = 32] | 11.0 m | 3.8 m | TNBC | NCT02322814 | Terminated | |
Cobimetinib (MEK1) + Chemotherapy | Cobimetinib (60 mg QD) on days 1–21 of each 28-day cycle; paclitaxel (80 mg/m2 QW); nab-paclitaxel (100 mg/m2 QW). | [n = 47] | 16. m | 5.4 m | |||||
I/II | Durvalumab (PD-L1) + Olaparib (PARP1/2) | olaparib (300 mg) in tablet form orally twice daily for 4 weeks and thereafter a combination of olaparib (300 mg) twice daily and durvalumab (1.5 g) via intravenous infusion every 4 weeks until disease progression | [n = 34] | 21.5 m | 8.2 m | Breast cancer | NCT02734004 | Active, not recruiting | |
II | Durvalumab (PD-L1) + Olaparib (PARP1/2) | Cediranib was taken intermittently 5 days on/2 days off at (15 or 20 mg) (dose levels 1 and 2, respectively) with durvalumab (1500 mg) IV every 4 weeks, and olaparib tablets (300 mg) twice daily. | [n = 35] | / | 3.4 m | Ovarian cancer | NCT02484404 | Recruiting | |
III | IL-2 + Dinutuximab beta (GD2) | dinutuximab beta (20 mg/m2 per day as an 8 h infusion for 5 consecutive days) | [n = 206] | 62% (5-year OS rate) | 57% (5-year EFS rate) | NB | NCT01704716 | Recruiting | |
Dinutuximab beta (GD2) | dinutuximab beta plus subcutaneous IL-2 (6×106 IU/m2 per day on days 1-5 and days 8-12 of each cycle) | [n = 200] | 63% (5-year OS rate) | 53% (5-year EFS rate) |