Table 5.

Ongoing trials of EV in combination with ICIs and TKIs.

Study	Drugs	Phase	No. of pts.	Population	Primary Endpoints
NCT05239624 (EV-ECLIPSE) [133]	EV + pembrolizumab	II	23	LA- or node-positive UC before surgery	pCR rate
NCT04963153 [134]	EV + erdafitinib	Ib	30	Metastatic UC progressed on platinul and PD1/L1 inhibitors with FGFR2/3 alterations	AEs; RP2D; MTD
NCT05524545 (ASPEN-07) [135]	EV + evorpacept (ALX148)	I	30	Mettastatic UC progressed on platinul and PD1/L1 inhibitors	DLTs; AEs
NCT05775471 [136]	Pembrolizumab + EV followed by pembrolizumab	II	21	Neoadjuvant before radical nephroureterectomy for high-risk UTUC followed by adjuvant pembrolizumab	ORR; RFS
NCT03924895 (KEYNOTE-905/EV-303) [137]	Pembrolizumab alone or pembrolizumab + EV or nothing	III	857	Perioperative treatment before cystectomy in cisplatin-ineligible or cisplatin-declining patients with MIBC	EFS
NCT04878029 [138]	EV +cabozantinib	Ib	32	Metastatic UC after progression on platine and ICIs	RP2D
NCT04960709 (VOLGA) [139]	Durva + treme + EV vs. durva + EV	III	830	MIBC ineligible for cisplatin or who refused cisplatin	pCR rate; EFS; AEs
NCT04223856 (EV-302) [140]	EV + pembrolizumab vs. chemotherapy	III	990	Previously untreated LA or metastatic UC	PFS; OS
NCT04700124 (KEYNOTE-B15/EV-304) [141]	Perioperative EV + pembrolizumab vs. neoadjuvant chemotherapy	III	784	Cisplatin-eligible MIBC	EFS

EV: enfortumab vedotin; LA: locally advanced; UC: urothelial carcinoma; pCR: pathologic complete response; AEs: adverse events; RP2D: recommended phase 2 dose; MTD: maximum tolerated dose; PD-1: programmed death-1; PD-L1: programmed death ligand-1; DLTs: dose-limiting toxicities; UTUC: upper-tract urothelial carcinoma; ORR: overall response rate; RFS: relapse-free survival; MIBC: muscle-invasive bladder cancer; EFS: event-free survival; ICIs: immune-checkpoint inhibitors; PFS: progression-free survival; OS: overall survival.