Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy

Sponsor
UNICANCER
Study ID
NCT03697850
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab after adjuvant radio-chemotherapy for the treatment of patients with muscle-invasive bladder cancer not eligible for radical cystectomy

Study Details

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.

Key Dates

Start date
Dec 14, 2018
Status verified
Dec 2024
Primary completion
Jun 15, 2025
Completion
Feb 15, 2029

Study Design

Enrollment
79 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: atezolizumab
    Anti-PD-L1 immunotherapy: atezolizumab (1200 mg) administered IV over 1 h every 3 weeks for 12 months (18 injections). Beginning 30 days (±5 days) after chemo-radiotherapy.

Primary Outcome Measure

Disease Free Survival [ Time Frame: 2 years ]

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