StudyFinder
An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)
Recruiting
We’re studying disitamab vedotin to find out what its side effects are and if it works for urothelial cancer when given with pembrolizumab. We want to see if these drugs work better together than the available approved treatments.
Male or Female
18 years and over
Inclusion Criteria:
• confirmed locally advanced unresectable or metastatic urothelial cancer (UC) including that originating from the renal pelvis, ureters, bladder, or urethra
• able to receive cisplatin- or carboplatin-containing chemotherapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:
• history of or active autoimmune disease that has required systemic treatment in the past 2 years
• prior solid organ or bone marrow transplantation
• pleural effusion or ascites with symptoms or requiring symptomatic treatment
Cancer
Urothelial Carcinoma
Halle Isom - halle.isom@fairview.org
Gautam Jha
STUDY00018433