Table 2.

Ongoing phase II/III trials with active recruitment on ICIs alone or in combination with chemotherapy in different settings of BC treatment.

Trial	Phase	Allocation	No. of Patients	Study Populations	Line of Treatment	Experimental Arms	Primary Outcome
NCT02736266	II	N/A	90	MIBC	neoadjuvant prior to chemoradiation	Pembrolizumab	pCR
NCT02845323	II	randomized	44	MIBC	neoadjuvant	Nivolumab + Urelumab vs. Nivolumab	Immune response (tumor infiltrating CD8+ T cell density)
NCT03520491	II	not randomized	45	Cisplatin-ineligible patients with MIBC	neoadjuvant	Nivolumab and Nivolumab + Ipilimumab	No. of patients who proceed to RC-PLND
NCT03472274	II	randomized	99	BC patients	neoadjuvant	Durvalumab and Tremelimumab	Antitumor activity
NCT03732677	III	randomized	1050	MIBC	neoadjuvant/adjuvant	Durvalumab + Gemcitabine + Cisplatin neoadjuvant treatment followed by Durvalumab alone for adjuvant treatment	EFS
NCT04138628	II	randomized	282	Treatment of mBC at the time of biochemical relapse following RC	adjuvant	Atezolizumab	CR
NCT03244384	III	randomized	739	Locally advanced and mUC	adjuvant	Pembrolizumab vs. observation	OS, DFS
NCT04223856	III	randomized	760	Previously untreated locally advanced or mUC	1st	Enfortumab vedotin + Pembrolizumab vs. chemotherapy alone	PFS, OS
NCT03036098	III	randomized	1290	Unresectable or mUC	1st	Nivolumab + Ipilimumab, or SoC chemotherapy vs. SoC Chemotherapy	OS, PFS
NCT03682068	III	randomized	1434	Unresectable locally advanced or mUC	1st	Durvalumab + SoC chemotherapy and Durvalumab + Tremelimumab and SoC Chemotherapy vs. SoC chemotherapy alone	OS
NCT03898180	III	randomized	694	Locally advanced or mUC	1st	Pembrolizumab + Lenvatinib vs. Pembrolizumab +placebo	PFS, OS
NCT03697850	II	randomized	77	MIBC patients ineligible for RC	maintenance therapy	Atezolizumab	DFS

Not applicable (N/A); number (No.); metastatic urothelial cancer (mUC); metastatic bladder cancer (mBC); standard of care (SoC); best supportive care (BSC); overall survival (OS); progression free survival (PFS); disease free survival (DFS); events free survival (EFS); pathological complete response (pCR); radical cystectomy and pelvic lymph node dissection (RC-PLND); muscle-invasive bladder cancer (MIBC).