Durvalumab (MEDI4736) and TREmelimumab in NEOadjuvant Bladder Cancer Patients (DUTRENEO)
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
In the treatment of localized/locally advanced urothelial cancer, there are several questions
that have not yet been resolved, such as the limited benefit of cisplatin-based chemotherapy
in the adjuvant or neoadjuvant context, the difficulty in establishing which groups actually
benefit from either perioperative treatment and what are the molecular markers that could
help us predict the response to this treatment to allow a better selection of patients. On
the other hand, not all patients are candidates for cisplatin-based chemotherapy and
carboplatin is not comparable in activity, so there is an urgent need to find other drugs
that may offer a therapeutic opportunity to these patients.
In the context of metastatic disease, immunotherapy has been able to modify the natural
history of this disease, administered as monotherapy, but the combination with double immune
checkpoint inhibitors is also being evaluated with promising results. Even this therapeutic
strategy is being advanced to the context of adjuvant and neoadjuvant treatment of urothelial
tumors. In this sense, on the one hand, the present study, as a research in the neoadjuvant
setting, constitutes the opportunity to define molecular phenotypes in bladder cancer since
the design of this study will allow both, to evaluate the efficacy of the drug when the tumor
is operable and to carry out an extensive analysis of biomarkers in the tumor tissue of these
patients with an in-vivo evaluation of immune-based therapy activity. On the other hand, it
allows to evaluate a strategy of double-immune checkpoint inhibitors that has already
demonstrated activity in metastatic disease and, taking into account, the modest benefit of
standard chemotherapy in the perioperative context: platinum-based neoadjuvant chemotherapy
in patients with muscle-invasive bladder cancer (MIBC) Modest increase in overall survival,
but only a subset of eligible patients are eligible to receive it. In addition, radical
cystectomy alone, in MIBC patients, presents a 5-year relapse rate of 10-50%.
Phase:
Phase 2
Details
Lead Sponsor:
Fundacion CRIS de Investigación para Vencer el Cáncer