The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced/metastatic urothelial carcinoma.
Patient ≥18 years at the day of consenting to the study
Provision of informed consent prior to any study specific procedures
Histologically confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter (upper urinary tract), bladder or urethra. Both transitional cell and mixed transitional/non-transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
Documented Stage IV disease (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1) not candidate to a curative treatment with surgery or radiotherapy at the start of first-line platinum-based chemotherapy.
Patient who has never received chemotherapy with a platinum salt (cisplatin or carboplatin) for advanced/metastatic urothelial carcinoma
Patient who has previously received more than one line of chemotherapy for advanced/metastatic urothelial carcinoma
Patient whose disease has progressed according to RECIST v1.1 criteria after the first line platinum-based chemotherapy for urothelial carcinoma. The cancer must not be in the progression phase at inclusion
Patient with known CNS metastases and/or carcinomatous meningitis
Centre Francois Baclesse
Lead sponsor
Pfizer
Collaborator