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A phase 3, open-label, randomized study of nivolumab combined with ipilimumab, or with standard of care chemotherapy, versus standard of care chemotherapy in participants with previously untreated unresectable or metastatic urothelial cancer. NCT03036098

A phase 3, randomized, comparator-controlled clinical trial to study the efficacy and safety of pembrolizumab (MK-3475) in combination with bacillus Calmette Guerin (BCG) in participants with high-risk non-muscle invasive bladder cancer (HR NMIBC) that is persistent or recurrent following BCG induction (KEYNOTE-676). NCT03711032

A phase II clinical trial to study the efficacy and safety of pembrolizumab (MK-3475) in subjects with high risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) therapy. NCT02625961

A phase III, randomized, open-label, controlled, multi-center, global study of first-line MEDI4736 (durvalumab) monotherapy and MEDI4736 (durvalumab) in combination with tremelimumab versus standard of care chemotherapy in patients with unresectable stage IV urothelial cancer. NCT02516241

A phase III randomized, open-label, multi-center, global study of durvalumab and Bacillus Calmette-Guerin (BCG) administered as combination therapy versus BCG alone in high-risk, BCG naïve non-muscle invasive bladder cancer patients. NCT03528694

Balar AV et al. Pembrolizumab (pembro) for the treatment of patients with Bacillus Calmette-Guérin (BCG) unresponsive, high-risk (HR) non-muscle-invasive bladder cancer (NMIBC): Over two years follow-up of KEYNOTE-057. ASCO 2020;Abstract 5041.

Balar A et al. Keynote 057: Phase II trial of pembrolizumab (pembro) for patients (pts) with high-risk (HR) nonmuscle invasive bladder cancer (NMIBC) unresponsive to bacillus Calmette Guerin (BCG). ASCO GU 2019;Abstract 350.

Grande E et al. IMvigor130: Efficacy and safety from a phase III study of atezolizumab (atezo) as monotherapy or combined with platinum-based chemotherapy (PBC) vs placebo + PBC in previously untreated locally advanced or metastatic urothelial carcinoma (mUC). ESMO 2019;Abstract LBA14_PR.

Powles T et al. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. ASCO 2020;Abstract LBA1.

Rosenberg JE et al. Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. GU Cancers Symposium 2020;Abstract 441.

Rosenberg JE et al. Pivotal trial of enfortumab vedotin in urothelial carcinoma after platinum and anti-programmed death 1/programmed death ligand 1 therapy. J Clin Oncol 2019;37(29):2592-600. Abstract

Siefker-Radtke AO et al. First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). ASCO 2018;Abstract 4503.