Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for the Treatment of Urothelial Bladder Cancer
The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.
• 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 without IV contrast) or as part of a FDG PET-CT;
⁃ Patients with microscopically involved (positive) surgical margins, but no grossly evident residual disease by imaging or physical exam are eligible.
• The patient is a candidate for definitive external beam radiotherapy;
‣ No prior radiotherapy to the region of study;
⁃ No inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist;
• Age greater than or equal to 18 years
• ECOG performance status: 0-2
• Concurrent non-investigational medications will be permitted
• In addition to diagnostic staging scan, patient will be considered eligible only if he/she has a CT simulation scan that does not show any evidence of recurrent disease
• Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility)