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Efficacy and safety of the combination of Cisplatin plus Nab-paclitaxel and Nivolumab with radiotherapy after maximal tumor resection in non-metastatic muscle invasive Bladder Cancer. (CA209-6E8, CNN-BC trial)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518937-26-00
Acronym
CA209-6E8, CNN-BC
Enrollment
24
Registered
2024-11-26
Start date
2023-02-21
Completion date
Unknown
Last updated
2025-10-02

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

Conditions

Patients with non-metastatic muscle invasive bladder cancer

Brief summary

The primary end point is one –year disease–free survival, which will be defined as the rate of survival free of recurrence in pelvic nodes or bladder (cis excluded), or appearance of distant metastasis with data censored at the first sign of disease or second primary tumor, or death

Detailed description

To describe the rate of patients who require salvage cystectomy, To describe the rate of locoregional complete response, To describe the rate of locoregional disease-free survival, To describe the median disease-free survival, To describe the median metastasis-free survival, To describe the safety of the combination of nivolumab plus cisplatin and nab-paclitaxel with concomitant RT, To describe the safety of nivolumab after RT, Quality of life

Interventions

DRUGPACLITAXEL ALBUMIN-BOUND
DRUGNIVOLUMAB
DRUGCISPLATIN

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary end point is one –year disease–free survival, which will be defined as the rate of survival free of recurrence in pelvic nodes or bladder (cis excluded), or appearance of distant metastasis with data censored at the first sign of disease or second primary tumor, or death

Secondary

MeasureTime frame
To describe the rate of patients who require salvage cystectomy, To describe the rate of locoregional complete response, To describe the rate of locoregional disease-free survival, To describe the median disease-free survival, To describe the median metastasis-free survival, To describe the safety of the combination of nivolumab plus cisplatin and nab-paclitaxel with concomitant RT, To describe the safety of nivolumab after RT, Quality of life

Countries

Italy

Outcome results

None listed

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