Clinical Trials | DS1062-328: A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed During or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) for a research study. The purpose of the study is to learn more about an investigational drug called datopotamab deruxtecan (Dato-DXd) when used in combination with platinum therapy (either carboplatin or cisplatin) that may help to treat your disease. This is a 2-part study, and you will be enrolled in only one of the 2 parts. Phase 2 studies provide more information about the safety of the new drug and how well the drug treats the disease. The Phase 2 part, called Part A, is to see how well Dato-DXd at doses of either 4 mg/kg or 6 mg/kg in combination with cisplatin or carboplatin work and are tolerated by you. If you are enrolled in this part, you will be assigned to one of 2 different doses of Dato-DXd in combination with cisplatin or carboplatin. Information from the first part will aid in selection of a dose to be used in the Phase 3 part, called Part B. Phase 3 studies expand on the information already obtained and involve a larger number of participants. Part B aims to compare how well Dato-DXd works when compared with either cisplatin or carboplatin, versus another treatment option, gemcitabine combined with either cisplatin or carboplatin. If you are enrolled in Part B, you will be assigned to receive either Dato-DXd (at the dose determined from Part A) in combination with cisplatin or carboplatin or gemcitabine in combination with cisplatin or carboplatin. You will be in this study for up to 4 years. Your treatment will be given in “cycles” and continue until the study doctor/Sponsor decides to stop your participation or you decide to discontinue. This could be due to a worsening or progression of your cancer, or other reasons. A cycle, which is 21 days, is a period of treatment before the next Treatment Period starts. The study is divided into the Screening, Treatment, and Follow-up Period