Seagen, a wholly owned subsidiary of Pfizer
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Inclusion Criteria: Cohorts A and B * Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra * Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy * At least one measurable lesion by investigator assessment based on RECIST version 1.1. * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample * Eastern Cooperative Oncology…
Given into the vein (IV; intravenous) every 2 weeks.
Given by IV on Day 1 of each 6-week cycle.