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Bladder Sparing : Phase II study of maintenance anti-PD-L1 treatment with atezolizumab after chemo-radiotherapy for muscle-infiltrating bladder cancer patients not eligible for radical cystectomy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512002-26-00
Enrollment
77
Registered
2024-05-24
Start date
2019-02-19
Completion date
Unknown
Last updated
2024-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle-invasive bladder cancer

Brief summary

Disease-free survival (DFS) will be assessed at 2 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first.

Detailed description

Local control rate will be evaluated by cystoscopy at 2 and 5 years. The presence of nonmuscle- invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour. Duration of local control will be calculated from the date of inclusion till the date of positive cystoscopy. In case of regional or distant relapse occurring before local relapse, data will be censored at the time of relapse., Disease-free survival (DFS) will be assessed at 5 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first., Overall Survival (OS) will be assessed at 2 and 5 years. OS is defined as the delay between the date of inclusion and the date of death, of any cause., The tolerance and safety will be evaluated by toxicity: acute (<6 months after the start of treatment) and late (≥6 months after the start of treatment), assessed using the NCI CTCAE v5.0 (see Appendix 2). The tolerance will be evaluated up until 5 years., Quality of life

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

Sponsors

Unicancer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease-free survival (DFS) will be assessed at 2 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first.

Secondary

MeasureTime frame
Local control rate will be evaluated by cystoscopy at 2 and 5 years. The presence of nonmuscle- invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour. Duration of local control will be calculated from the date of inclusion till the date of positive cystoscopy. In case of regional or distant relapse occurring before local relapse, data will be censored at the time of relapse., Disease-free survival (DFS) will be assessed at 5 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first., Overall Survival (OS) will be assessed at 2 and 5 years. OS is defined as the delay between the date of inclusion and the date of death, of any cause., The tolerance and safety will be evaluated by toxicity: acute (<6 months after the start of treatment) and late (≥6 months after the start of tr

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026