Skip to content

An open label, single-arm, phase 2 study of neoadjuvant sacituzumab govitecan, before radical cystectomy, for patients with muscle-invasive bladder cancer who cannot receive or refuse cisplatin-based chemotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515301-26-00
Acronym
SURE-01
Enrollment
56
Registered
2024-10-14
Start date
2022-03-23
Completion date
2025-09-24
Last updated
2026-01-08

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

Number of complete pathological responses, defined as the absence of viable tumor cells on the histological examination of the cystectomy. Evidence of carcinoma in situ or non-muscle infiltrating disease does not define a complete pathological response.

Detailed description

Evaluation of safety and tolerability of the treatment: Number of patients who experienced adverse events. Type, frequency, severity and relationship to the treatment of the adverse events, evaluated according the Common Toxicity Criteria for adverse events (CTCAE) v 5.0. Progression free survival Overall survival

Interventions

DRUGTrodelvy 200 mg powder for concentrate for solution for infusion

Sponsors

Ospedale San Raffaele S.r.l.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of complete pathological responses, defined as the absence of viable tumor cells on the histological examination of the cystectomy. Evidence of carcinoma in situ or non-muscle infiltrating disease does not define a complete pathological response.

Secondary

MeasureTime frame
Evaluation of safety and tolerability of the treatment: Number of patients who experienced adverse events. Type, frequency, severity and relationship to the treatment of the adverse events, evaluated according the Common Toxicity Criteria for adverse events (CTCAE) v 5.0. Progression free survival Overall survival

Countries

Italy

Outcome results

None listed

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