A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer

Inclusion Criteria:

• Ability of participant to understand this study, and participant willingness to sign awritten informed consent.
• Participants must have histologically or cytologically confirmed locally advancedunresectable or metastatic urinary bladder (urothelial) cancer. Participants withmixed histologies are permitted as long as transitional cell carcinoma is present inthe pathological specimen.
• Participants must have measurable disease, defined as at least one lesion that can beaccurately measured in at least one dimension
• Documented progression on or within 12 months of treatment with one previousplatinum-containing regimen or ineligible to receive platinum-containing regimen.Neo-adjuvant or adjuvant platinum-based chemotherapy will be deemed to be first-linewhen participants progressed within 12 months of the last dose
• Documented progression on prior checkpoint inhibitor or ineligible to receivecheck-point inhibitor
• Adequate performance status, organ, and marrow function.
• Women of child-bearing potential and men with partners of child-bearing potential mustagree to practice sexual abstinence, or to use two forms of adequate contraception.
• Men of child-bearing potential must not father a child or donate sperm while on thisstudy and for 6 months after their last study treatment

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks ofenrollment/registration.
• Current or anticipated use of other investigational agents while participating in thisstudy.
• Psychiatric illness/social situations that would limit compliance with studyrequirements.
• Pregnant or breast feeding (if applicable).
• Patients with known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to TAS 102.
• Patients with HIV on anti-retro-viral therapy with thymidine kinase substrates, forexample, stavudine, zidovudine, telbivudine.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, or cardiacarrhythmia. Undergoing active treatment for a co-existing malignancy with theexception of adequately treated basal cell carcinoma, squamous cell skin cancer,thyroid cancer or incidental prostate adenocarcinoma detected at radical cystectomy