Table 2.

Planned, ongoing, and completed trials incorporating targeted or immune therapy

lst-line, CE	lst-line, CI	2nd-line	Phase	Closed	Novel target	Intervention arm(s)	Control arm (if applicable)	ClinicalTrials.gov identifier
Targeted therapies
		X	II	X	EGFR, HER2	Afatinib		NCT02122172
		X	II		FGFR3	B-701 + docetaxel	Placebo + docetaxel	NCT02401542
		X	II		Cancer stem cell growth	BBI503		NCT02232646
X			III	X	VEGF	Bevacizumab + GC	Placebo + GC	NCT00942331
		X	II	X	FGFR3	BIBF1120		NCT02278978
		X	II	X	PI3 K	Buparlisib		NCT01551030
		X	II	X	c-Met, VEGFR-2, RET	Cabozantinib		NCT01688999
		X	II		c-Met, RON	Crizotinib		NCT02612194
	X		II	X	mTOR	Everolimus ± paclitaxel		NCT01215136
		X	II	X	mTOR	Everolimus		NCT00805129
		X	II		FGFR	JNJ-42756493		NCT02365597
X	X		II/III	X	HER2, HER1	Lapatinib after lst-line therapy	Placebo after 1st-line therapy	NCT00949455
		X	II	X	HDAC	Mocetinostat		NCT02236195
		X	II	X	Hsp27	OGX-427 + Docetaxel	Docetaxel	NCT01780545
		X	II		CDK4, CDK6	Palbociclib		NCT02334527
		X	III		VEGFR-2	Ramucirumab + docetaxel	Placebo + docetaxel	NCT02426125
		X	II	X	mTOR	Temsirolimus		NCT01827943
		X	II		FTase	Tipifarnib		NCT02535650
X			II		ATR kinase	VX-970 + GC	GC	NCT02567409
Immunotherapy
		X	III	X	PD-L1	Atezolizumab	Vinflunine, paclitaxel, or docetaxel	NCT02302807
X	X		III		PD-L1	Avelumab + BSC after lst-line therapy	BSC after 1st-line therapy	NCT02603432
X			II	X	CTLA-4	Ipilimumab + GC		NCT01524991
		X	II		PD-1; CTLA-4	Nivolumab then nivolumab + ipili- mumab at progression		NCT02553642
		X	II	X	PD-1	Nivolumab		NCT02387996
X	X		II		PD-1	Pembrolizumab after lst-line therapy	Placebo after 1st-line therapy	NCT02500121
	X		II		PD-1	Pembrolizumab		NCT02335424
		X	III	X	PD-1	Pembrolizumab	Vinflunine, paclitaxel, or docetaxel	NCT02256436
			II		PD-1	Pembrolizumab + paclitaxel		NCT02581982
		X	II	X	PD-1; Bruton tyrosine kinase	Pembrolizumab ± ACP-196		NCT02351739
		X	II		PD-1	Recombinant fusion protein sEphB4-HSA + pembrolizumab		NCT02717156

CLinicalTrials.gov was accessed on May 2, 2016, to compile a table of planned, ongoing, and completed trials (verified since May 2014, completed since May 2015, and had no published results per ClinicalTrials.gov) for metastatic UC, including UTUC

ATR ataxia telangiectasia and Rad3 related, BSC best supportive care, CDK4 cyclin-dependent kinase 4, CDK6 cyclin-dependent kinase 6, CE cisplatin-eligible, CI cisplatin-ineligible, CTLA-4 cytotoxic T lymphocyte-associated protein 4, EGFR epidermal growth factor receptor, FGFR fibroblast growth factor receptor, FGFR3 fibroblast growth factor receptor 3, FTase farnesyltransferase, GC gemcitabine plus cisplatin, HDAC histone deacetylase, HER1 human epidermal growth factor receptor 1, HER2 human epidermal growth factor receptor 2, Hsp27 heat shock protein 27, mTOR mechanistic target of rapamycin, PD-1 programmed death 1, PD-L1 programmed death ligand 1, PI3 K phosphoinositide 3-kinase, RET rearranged during transfection, RON Recepteur d’Origine Nantais, sEphB4-HSA soluble ephrin type-B receptor 4-human serum albumin, VEGF vascular endothelial growth factor, VEGFR-2 vascular endothelial growth factor receptor 2