A Phase 2 Multi Cohort Open Label Multi Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48 ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Brief description of study

This research study is testing two treatments for a type of bladder cancer (Urothelial Carcinoma that expresses HER2) that has spread or is hard to treat. The study team is trying out a medicine called disitamab vedotin by itself or together with another drug called pembrolizumab as treatment. The study includes five groups of people with different types of this cancer. Some have had treatment before, and others are new to treatment. The study will look at how well these treatments work in treating the cancer and how few side effects they cause. The study aims to include patients from Japan in separate groups as well. They'll check how the cancer responds, if there are any side effects, and how long people live after the treatment.


Clinical Study Identifier: s23-00807
ClinicalTrials.gov Identifier: NCT04879329
Principal Investigator: Scot Niglio.
Other Investigators: Minas Platon Economides, Victor Ricardo Adorno Febles, Laura Catherine Bauer, Mary K O'Keeffe, Hank Ng, David R. Wise.


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