Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer
Trial Parameters
Brief Summary
The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.
Eligibility Criteria
Inclusion Criteria: * Pure or mixed variant urothelial carcinoma o Allowable mixed variant subtypes include: * squamous differentiation * glandular differentiation * nested pattern * microcystic * micropapillary * lymphoepthelioma-like * plasmacytoid and lymphoma-like * sarcomatoid/carcinosarcoma * giant cell * trophoblastic differentiation * clear cell * lipid cell * undifferentiated * Radical cystectomy and pelvic lymph node dissection within the prior 48 weeks * Pathologic T3 or higher stage disease, any N, M0 (AJCC, 7th Ed., Appendix C) * Receiving adjuvant checkpoint inhibitor therapy * No clinical evidence of residual or recurrent disease based on the following minimum diagnostic work-up within 3 months of a patient's consent to participate. * History and physical examination * Chest imaging by x-ray (PA and lateral views), CT scan (with or without IV contrast) or as part of a FDG PET-CT; * Axial abdominal and pelvic imaging by MRI (preferably with gadolinium), CT scan (with or w