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Currently, single-agent immune checkpoint inhibitors (ICIs) and the combination of pembrolizumab with the antibody\u2013drug conjugate enfortumab vedotin are approved to treat patients with metastatic UC (mUC). Approval of first-line nivolumab in combination with gemcitabine and cisplatin is expected imminently. Many treatment approaches are being investigated to better harness the immune system to fight mUC. In this review, we summarize the landmark clinical trials of ICIs that led to their incorporation into the current standard of care for mUC. We further discuss recent and ongoing clinical trials in mUC, which are investigating ICIs in combination with other agents, including chemotherapy, antibody\u2013drug conjugates, tyrosine kinase inhibitors, and novel antibodies. Lastly, we review novel approaches utilizing bispecific antibodies, cellular therapies, and vaccines. The landscape of immunotherapy for mUC is rapidly evolving and will hopefully lead to better outcomes for patients.<\/jats:p>","DOI":"10.3390\/cancers16020335","type":"journal-article","created":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T03:54:34Z","timestamp":1705031674000},"page":"335","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["A Comprehensive Review of Immunotherapy Clinical Trials for Metastatic Urothelial Carcinoma: Immune Checkpoint Inhibitors Alone or in Combination, Novel Antibodies, Cellular Therapies, and Vaccines"],"prefix":"10.3390","volume":"16","author":[{"given":"Dixita M.","family":"Patel","sequence":"first","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruba","family":"Mateen","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Franciscan Health Olympia Fields, Olympia Fields, IL 60461, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noor","family":"Qaddour","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Advocate Christ Medical Center, Oak Lawn, IL 60453, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Carrillo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Franciscan Health Olympia Fields, Olympia Fields, IL 60461, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Verschraegen","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH 43210, USA"},{"name":"The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"},{"name":"Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanquan","family":"Yang","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH 43210, USA"},{"name":"Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zihai","family":"Li","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH 43210, USA"},{"name":"The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"},{"name":"Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debasish","family":"Sundi","sequence":"additional","affiliation":[{"name":"The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"},{"name":"Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"},{"name":"Department of Urology, College of Medicine, The Ohio State University, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amir","family":"Mortazavi","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH 43210, USA"},{"name":"The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0485-8031","authenticated-orcid":false,"given":"Katharine A.","family":"Collier","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH 43210, USA"},{"name":"The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"},{"name":"Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,1,12]]},"reference":[{"key":"ref_1","unstructured":"(2023, April 02). 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