Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer
Trial Parameters
Brief Summary
Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Have histologically confirmed urothelial carcinoma of the bladder, upper urinary tract or urethra; a maximum of 50% of aberrant histology is allowed. 3. Have clinical stage cT4NxM0 or cTxN1-N3M0 as assessed by bimanual examination under anaesthesia, CT scan, MRI scan or PET-CT scan. 4. Have at least stable disease after a minimum of 3 or a maximum of 4 cycles of induction chemotherapy with cisplatin / carboplatin + gemcitabine according to RECIST v1.1. 5. Are fit and willing to undergo radical surgery with removal of lymph node template including all affected lymph nodes and the primary tumor. 6. World Health Organisation performance status of 0-2. 7. Provide written informed consent. 8. Negative pregnancy test in women with childbearing potential. 9. Adequate bone marrow function, including: 1. Absolute neutrophil count (ANC) ≥1,500/mm3 or 1.5 x 109/L; 2. Platelets ≥100 x 109/L; 3. Hemoglobin ≥5.6 mmol/L (may have been transfused). 10. Adequat