Table 4.

Recruiting or active, not recruiting phase II and III clinical trials with neoadjuvant therapy for MIBC.

Trial	Status	Phase	N of Patients	Neoadjuvant Treatment	Primary endpoint
NCT04861584	Recruiting	II/III	41	Toripalimab with gemcitabine and cisplatin	Pathologic RR evaluated after 4 cycles
NCT04060459	Recruiting	II	50	Paclitaxel-binding albumin + cisplatin	pCR (<pT0)
NCT03472274	Recruiting	II	99	Durvalumab + tremelimumab	Antitumor activity
NCT03674424	Recruiting	II/III	166	Avelumab± chemotherapy	pCR (ypT0/TisN0)
NCT04700124	Recruiting	III	784	Perioperative enfortumab vedotin plus pembrolizumab vs. NAC	pCR EFS
NCT04730219	Recruiting	II	69	Tislelizumab with nab-paclitaxel	pCR
NCT04543110	Recruiting	II	25	Radiation + durvalumab	pCR
NCT02690558	Active, not recruiting	II	39	Pembrolizumab with gemcitabine and cisplatin	Pathologic downstaging
NCT03732677	Active, not recruiting	III	988	Durvalumab + gemcitabine/cisplatin (neoadjuvant treatment) and durvalumab (adjuvant treatment)	pCR EFS
NCT04209114	Recruiting	III	540	Nivolumab plus bempegaldesleukin vs. nivolumab alone vs. standard of care cisplatin ineligible	pCR EFS
NCT02736266	Recruiting	II	90	Pembrolizumab	pCR
NCT04430036	Recruiting	II	42	AGEN1884 +AGEN2034 with cisplatin-gemcitabine	Pathologic tumor downstaging of >T2 to pT0
NCT03924856	Recruiting	III	870	Perioperative pembrolizumab + NAC vs. perioperative placebo + NAC	pCR EFS
NCT03294304	Active, not recruiting	II	43	Nivolumab + gemcitabine and cisplatin	PaR
NCT03558087	Active, not recruiting	II	76	Gemcitabine and cisplatin + nivolumab	Clinical CR rate (cT0-Ta)
NCT04289779	Recruiting	II	42	Cabozantinib with atezolizumab	pRR
NCT04047693	Recruiting	II	32	Dose dense MVAC in MIBC and locally advanced urothelial carcinoma	pCR
NCT02365766	Active, not recruiting	I/II	83	Neoadjuvant pembrolizumab with gemcitabine	Rate of pathologic muscle invasive response
NCT04383743	Recruiting	II	17	Pembrolizumab and chemotherapy	pCR
NCT02451423	Recruiting	II	42	Atezolizumab	Change in CD3+ T cell count/µm2 in multi-dose cohorts; pathologic T0 rate in expansion cohorts
NCT03061630	Recruiting	II	48	Chemotherapy with gemcitabine/platinum	PaR
NCT03768570	Recruiting	II	238	Trimodality therapy with/out durvalumab	DFS
NCT00777491	Active, not recruiting	II	70	Chemotherapy and radiation therapy in stage II-III BC	Percentage of patients without distant metastases at 3 years
NCT02845323	Recruiting	II	44	Nivolumab ± urelumab in cisplatin-ineligible or chemotherapy-refusing patients	Immune response measured by tumor infiltrating CD8+ T cell density at cystectomy

Muscle invasive bladder cancer (MIBC), number (N), response rate (RR), pathologic complete response (pCR), event-free survival (EFS), pathologic response (PaR), disease-free survival (DFS), methotrexate-vinblastine-doxorubicin-cisplatin (MVAC).