Table 1.
Trials | NCT | Phase | Cancer type | Size (Intervention/Control) | Intervention | Dose | Control | Follow-up duration (intervention) | Primary outcome | Description of irAEs |
---|---|---|---|---|---|---|---|---|---|---|
Maio 201719 | 01843374 | 2 | Mesothelioma | 569 (380/189) | Tremelimumab | 10 mg/kg | Placebo | NA | OS | No |
Govindan 201720 | 01285609 | 3 | NSCLC | 948 (475/473) | Ipilimumab + Chemotherapy | 10 mg/kg | Chemotherapy + Placebo | 12.5 months | OS | Yes |
Beer 201721 | 01057810 | 3 | mCRPC | 600 (399/199) | Ipilimumab | 10 mg/kg | Placebo | NA | OS | Yes |
Reck 201622 | 01450761 | 3 | SCLC | 954 (562/561) | Ipilimumab + Chemotherapy | 10 mg/kg | Chemotherapy + Placebo | 10.5 months | OS | Yes |
Eggermont 20167 | 00636168 | 3 | Melanoma | 945 (471/474) | Ipilimumab | 10 mg/kg | Placebo | 63.6 months | RFS | Yes |
kwon 201423 | 00861614 | 3 | mCRPC | 799 (393/396) | Ipilimumab + Radiotherapy | 10 mg/kg | Radiotherapy + placebo | 9·9 months | OS | Yes |
Ribas 201324 | 00257205 | 3 | Melanoma | 644 (325/319) | Tremelimumab | 15 mg/kg | Chemotherapy | 31 months | OS | No |
Reck 201217 | 00527735 | 2 | SCLC | 86 (42/44) | Ipilimumab (Phased)# | 10 mg/kg | Chemotherapy + Placebo | NA | irPFS | Yes |
86 (42/44) | Ipilimumab# (Concurrent) | 10 mg/kg | Chemotherapy + Placebo | |||||||
Lynch 201218 | 00527735 | 2 | NSCLC | 132 (67/65) | Ipilimumab# (Phased) | 10 mg/kg | Chemotherapy + Placebo | NA | irPFS | Yes |
136 (71/65) | Ipilimumab# (Concurrent) | 10 mg/kg | Chemotherapy + Placebo | |||||||
Robert 201125 | 00324155 | 3 | Melanoma | 498 (247/251) | Ipilimumab + Chemotherapy | 10 mg/kg | Chemotherapy + Placebo | NA | OS | Yes |
Hodi 20108 | 00094653 | 3 | Melanoma | 512 (380/132) | Ipilimumab + gp100 | 3 mg/kg | gp100 | 21 months | OS | Yes |
263 (131/132) | Ipilimumab | 3 mg/kg | gp100 | 27.8 months |
Notes: # concurrent, ipilimumab + paclitaxel/carboplatin followed by placebo + paclitaxel/carboplatin; phased, placebo + paclitaxel/carboplatin followed by ipilimumab + paclitaxel/carboplatin.
Abbreviations: NA, not available; OS, overall survival; NSCLC, non-small cell lung cancer; SCLC, small cell lung cancer; mCRPC, metastatic castration resistant prostate cancer; irAEs, immune-related adverse events; irPFS, immune-related progression-free survival.