Deze studie is in de week van 4 juni 2018 gesloten wegens het behalen van het gewenste aantal inclusies. Volg de DUOS site voor de resultaten.
PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB
(ANTI−PD-L1 ANTIBODY) VERSUS OBSERVATION AS ADJUVANT THERAPY IN PATIENTS WITH
HIGH-RISK MUSCLE-INVASIVE BLADDER CANCER AFTER CYSTECTOMY
AIM; To evaluate the efficacy of adjuvant atezolizumab treatment in patients with muscle invasive bladder cancer (MIBC), as measured by disease-free survival (DFS)
Study WO29636 is a global Phase III, open-label, randomized, controlled trial designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in patients with MIBC who are at high risk for recurrence following cystectomy.
Male and female patients aged ≥ 18 years with ECOG performance status ≤ 2 who have histologically or cytologically confirmed muscle-invasive UC (also termed TCC) of the bladder and who have undergone radical cystectomy with lymph node dissection are eligible.
Patients who have received prior neoadjuvant chemotherapy are eligible, but must have tumor staging of ypT2−4a or ypN+ at pathological examination of the cystectomy specimen.
Patients who have not received prior neoadjuvant chemotherapy must be ineligible for or declined treatment with cisplatin-based adjuvant chemotherapy and have tumor staging of pT3−4a or pN+. The EAU only recommends chemo adjuvant in clinical trials. In that sense, it’s OK to read as the patients refuse chemo adjuvant under the physician’s guidance
For patients treated with prior neoadjuvant chemotherapy: tumor stage of pT2−T4a or
For patients who have not received prior neoadjuvant chemotherapy: tumor stage of
pT3−T4a or pN+
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