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 a
written informed consent.

- Participants must have histologically or cytologically confirmed locally advanced
unresectable or metastatic urinary bladder (urothelial) cancer. Participants with
mixed histologies are permitted as long as transitional cell carcinoma is present in
the pathological specimen.

- Participants must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension

- Documented progression on or within 12 months of treatment with one previous
platinum-containing regimen or ineligible to receive platinum-containing regimen.
Neo-adjuvant or adjuvant platinum-based chemotherapy will be deemed to be first-line
when participants progressed within 12 months of the last dose

- Documented progression on prior checkpoint inhibitor or ineligible to receive
check-point inhibitor

- Adequate performance status, organ, and marrow function.

- Women of child-bearing potential and men with partners of child-bearing potential must
agree 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 this
study and for 6 months after their last study treatment

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks of
enrollment/registration.

- Current or anticipated use of other investigational agents while participating in this
study.

- Psychiatric illness/social situations that would limit compliance with study
requirements.

- Pregnant or breast feeding (if applicable).

- Patients with known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to TAS 102.

- Patients with HIV on anti-retro-viral therapy with thymidine kinase substrates, for
example, stavudine, zidovudine, telbivudine.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia. Undergoing active treatment for a co-existing malignancy with the
exception of adequately treated basal cell carcinoma, squamous cell skin cancer,
thyroid cancer or incidental prostate adenocarcinoma detected at radical cystectomy