Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for the Treatment of Urothelial Bladder Cancer
Abramson Cancer Center at Penn Medicine
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.
Description
Patients in this study will receive the standard of care procedures and follow-up for immunotherapy and radiation therapy. The part of this study that is research is receiving both of these treatments at the same time. Safety will be based on acute toxicity.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ch…
Interventions
- RadiationConcurrent Immunotherapy and Radiation Therapy
Radiation therapy will begin between 12 to 18 weeks from the start of adjuvant nivolumab. Patients will receive radiation therapy for about 6 weeks.
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania