The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
Adequate renal and hepatic function.
Adequate hematologic parameters without transfusional support.
Females who are pregnant or lactating.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Has an active second malignancy.
Has known active Hepatitis B or Hepatitis C.
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Treatment groupsSee each treatment group below.
Gilead Sciences
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborator