Discussion
MIBC, CHASIT
DISEASE
Maintenance therapy with avelumab has shown to be well-tolerated and beneficial for survival in metastatic MIBC patients who had at least stable disease after systemic chemotherapy [Chemotherapy in the neoadjuvant setting is effective to obtain a pathological complete response. Neoadjuvant treatment of cT2-T4aN0M0 patients with MVAC increased the pCR rate from 15% after cystectomy alone to 38% [Although ideally a randomized controlled trial (RCT) is the preferred study design, an RCT would necessitate a large number of subjects to be included, making it logistically and financially challenging to conduct this trial. This does not seem feasible on a national level. Therefore, we decided to conduct a single arm phase II study. If the CHASIT study shows that sequential chemo-immunotherapy leads to a pCR rate of ≥ 30%, an international randomized controlled trial is foreseen to compare this new treatment regimen to standard care.