Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy (NCT03697850) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy
France79 participantsStarted 2018-12-14
Plain-language summary
Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient's refusal.
This study is designed as a multicentre, single-arm phase II study.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Muscle-invasive bladder cancer (MIBC) pT2-T3 histologically confirmed:
✓. Complete transurethral resection of bladder tumour (TURBT), either:
✓. Patients for which chemo-radiotherapy is planned
✓. No major pelvic involvement: pelvic nodes ≤15 mm on CT scan.
✓. No distant metastasis.
✓. Patient unfit for radical cystectomy because of age, comorbidities, or patient's refusal.
✓. Patients ≥18 years old
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Exclusion criteria
✕. Prior pelvic irradiation.
✕. MIBC histology other than urothelial or squamous cell carcinomas (e.g., adenocarcinomas, micropapillary, sarcomas, or small cell histological types).
✕. History of neoplastic disease, during the 3 years before selection, except completely resected cutaneous basal-cell carcinomas, carcinoma in-situ or localised prostate cancer without biochemical recurrence following definitive treatment.
✕. Prior treatment with CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies.