Table Info

Table 3.

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
IMbrave151 NCT04677504	II	150 patients	Atezolizumab plus bevacizumab plus CisGem¹	Atezolizumab plus placebo plus CisGem¹	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 CisGem¹	Placebo plus CisGem¹	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-1 NCT03875235	III	757 patients	Durvalumab plus CisGem¹	Placebo plus CisGem¹	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-966 NCT04003636	III	1048 patients	Pembrolizumab plus CisGem¹	Placebo plus CisGem¹	OS	ORR, DOR, PFS per RECIST v1.1 by ICR, safety
NCT03478488	III	480 patients	KN035 plus GEMOX²	GEMOX²	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

Declarations

Author contributions

MGP, LR, AC, AD and VZ contributed to conception and design of the work. All authors wrote the manuscript, contributed to manuscript revision, read and approved this submitted version.

Conflicts of interest

LR received consulting fees from Amgen, ArQule, AstraZeneca, Basilea, Bayer, BMS, Celgene, Eisai, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi, Servier, Zymeworks; lecture fees from AbbVie, Amgen, Bayer, Eisai, Gilead, Incyte, Ipsen, Lilly, Merck Serono, Roche, Sanofi; travel expenses from Ipsen; and institutional research funding from Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Zymeworks. The other authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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