Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy

Inclusion Criteria

• Diagnosis of Urothelial carcinoma (UC) of the bladder, with histologic confirmation of primary UC pathology; indication for Radical cystectomy (RC); ineligibility for platinum-based neoadjuvant chemotherapy
• ECOG Performance Status (PS) 0 or 1.
• Ability to provide informed consent.
• Willingness to comply with all required protocol procedures including providing biologic specimens and returning to the clinical study site for follow up visits.
• Performance status sufficient to undergo RC (in the opinion of the enrolling urologist) including adequate hematological, liver and kidney function
• Must be willing to implement contraception throughout study and for 30 days following RC.

Exclusion Criteria

• Variant UC pathology including but not limited to micropapillary, signet ring,sarcomatoid, and clear cell variants.
• Patients with any other prior malignancy are not allowed except for the following: History of or concurrent non-invasive UC involving a portion of urinary tract outside of the bladder; Adequately treated basal cell or squamous cell skin cancer; In situ cervical cancer; Adequately treated Stage I or II cancer from which the patient is currently incomplete remission or other cancer from which the patient has been disease-free for 2 years.
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
• Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration. Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to registration
• Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
• Pregnant women.
• Nursing women.
• Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment.
• Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
• History of organ transplantation.