Ongoing first-line randomized phase II–III trials with ICI for advanced BTCs
| Study name/number | Phase | Estimated sample size | Experimental treatment | Comparator | Primary endpoint | Secondary endpoints |
|---|---|---|---|---|---|---|
| IMbrave151NCT04677504 | II | 150 patients | Atezolizumab plus bevacizumab plus CisGem | Atezolizumab plus placebo plus CisGem | PFS per RECIST v1.1 by the investigator | OS, ORR, DOR, DCR per RECIST v1.1 by investigator, TTCD, safety, ADAs for atezolizumab |
| NCT04066491 | II–III | 512 patient | Bintrafusp alfa (M7824) plus CisGem | Placebo plus CisGem | Safety run-in part: DLTs Double-blinded part: OS | ORR, DOR, PFS per RECIST v1.1 by investigator, safety, Bintrafusp alfa PK, ADAs for Bintrafusp alfa |
| TOPAZ-1NCT03875235 | III | 757 patients | Durvalumab plus CisGem | Placebo plus CisGem | OS | PFS, ORR, DOR per RECIST v1.1 by ICR and by investigator, OS by PD-L1 expression, PK of durvalumab, ADAs for durvalumab, QoL |
| KEYNOTE-966NCT04003636 | III | 1048 patients | Pembrolizumab plus CisGem | Placebo plus CisGem | OS | ORR, DOR, PFS per RECIST v1.1 by ICR, safety |
| NCT03478488 | III | 480 patients | KN035 plus GEMOX | GEMOX | OS | PFS, ORR, DCR, DOR, TTP per RECIST v1.1 by ICR |
CisGem: cisplatin 25 mg/mq + gemcitabine 1000 mg/mq intravenously (i.v.) on day 1 and 8 on a 21-day cycle up to 8 cycles; 2GEMOX: gemcitabine 1000 mg/mq on day 1 and 8 and oxaliplatin 85 mg/mq i.v. on day 1 of a 21-day cycle up to 6 cycles. TTCD: time to clinical deterioration; ADAs: anti-drug antibodies; DLTs: dose-limiting toxicities; PK: pharmacokinetics; TTP: time to progression