Inclusion Criteria:

• Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.
• Diagnosis of locally advanced unresectable or metastatic stage disease (American Joint Commission on Cancer Stages TNM Stage IIIB–IV, (Amin 2017)).
• Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing. Tumor tissue must be from a muscle-invasive bladder cancer sample or metastatic site and must be the most recent tissue relative to the index date.
• At least 1 prior line of systemic therapy for LA/mUC, including 1 line of platinum-containing chemotherapy:
  • Neoadjuvant or adjuvant systemic therapy, with progression within 12 months of completing last dose of therapy, is considered a LOT;
  • Maintenance avelumab therapy delivered following first-line platinum therapy is not considered a separate LOT;
  • Prior therapy with PD-1 and/or PD-L1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy, or as second-line treatment is allowed.
• Initiation of therapy after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the start of data collection (index date).
• Radiographically documented and measurable disease progression immediately before index date.
• Age ≥ 18 years at index date or considered an adult in accordance with local regulations.

Exclusion Criteria:

• Any concurrent malignant neoplasm requiring systemic therapy during the study window (01 January 2019 to the start of data collection).
• Explicit refusal recorded in the medical records of not wishing to participate in medical research.
• Enrollment in a therapeutic clinical trial and received non-standard of care treatment within 1 year prior to the index date.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/8/22. Questions regarding updates should be directed to the study team contact.