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.
The first line treatment of urothelial carcinoma is a platinum-based chemotherapy. This
treatment is efficient with a response rate > 50 % but the progression-free survival is short
(7.7 months) and the chemotherapy is too toxic to be used in a prolonged time. Traditionally,
maintenance chemotherapy refers to the utilization of regimens with less toxicity after the
initial upfront treatment. This concept has already been efficient with PARP inhibitors in
ovarian carcinoma and more recently with durvalumab in lung carcinoma.
The prevalence of somatic mutations in homologous recombination genes in UC as well as their
association with platinum sensitivity suggests Talazoparib to be a target for a maintenance
treatment of urothelial carcinoma. Moreover, there is a strong rational with both
pre-clinical and clinical data to associate Avelumab and Talazoparib. This appears all the
more relevant that Avelumab has already demonstrated its efficacy in urothelial carcinoma
(after platinum-based chemotherapy failure).
In this context, the sponsorpropose a phase 2 study to assess the antitumor activity of the
combination of Avelumab plus Talazoparib in metastatic urothelial carcinoma in maintenance
therapy after platinum-based chemotherapy.
Considering the doubts about the best molecular predictive factors of Talazoparib and
Avelumab, the sponsor willingly propose a non-selective study, without molecular screening.
Tumors will be selected according to the platinum sensitivity which has the advantage to
exclude poor prognosis tumors and will allow increasing the HRD tumor population.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.