A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

• Have histologically or cytologically confirmed, locally advanced or unresectable or metastatic urothelial (transitional cell) carcinoma of the bladder, urethra, ureter, or renal pelvis.

• Had disease progression while on a platinum containing regimen in the first-line setting or within 14 months after completing the first-line platinum regimen. Participants who received treatment with one immune checkpoint inhibitor regimen are eligible (for example Programmed death 1 (PD-1), Programmed death-ligand 1 (PDL1), or CTLA4) and may have a longer interval since prior platinum-containing therapy (≤24 months).

• Have a life expectancy of ≥3 months.

• Have received no more than one prior systemic chemotherapy regimen in the relapsed or metastatic setting. Prior treatment with no more than one prior immune checkpoint inhibitor is permitted and will not be considered as a line of systemic chemotherapy.

• Have measurable disease or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

• Have an Eastern Cooperative Oncology Group (ECOG) of 0 or 1.

• Have adequate hematologic function.

• Have adequate coagulation function.

• Have adequate hepatic function.

• The participant does not have:

‣ cirrhosis at a level of Child-Pugh B (or worse)

⁃ cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis

• Have adequate renal function as defined by creatinine clearance \>30 milliliters/minute.

• Have urinary protein ≤1+ on dipstick or routine urinalysis.

• The participant is willing to provide blood, urine, and tissue samples for research purposes.