Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment
• Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra.
• Prior anti-PD-(L)1 treatment.
• Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI.
• Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy.
• Adequate organ and marrow function as defined
• Must have a life expectancy of at least 12 weeks.
• Body weight > 30 kg

Exclusion Criteria

• History of allogeneic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure .
• History of another primary malignancy
• History of leptomeningeal carcinomatosis.
• History of active primary immunodeficiency.
• Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus .
• Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria