CompletedPhase 2

Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer

Italy44 participantsStarted 2022-03-23

Plain-language summary

SURE-01 is a neoadjuvant phase 2, open-label, non-randomized, singlecohort study in patients with urothelial carcinoma of the bladder. Patients will be consecutively enrolled and treated. The primary objective of the study is to assess whether sacituzumab govitecan results in pathological complete response (in patients with Muscle-invasive Bladder Cancer who cannot receive or refuse cisplatin-based chemotherapy). Secondary objectives were to evaluate the radiological response of those patients with measurable disease; to evaluate the surgical and medical safety of neoadjuvant therapy; to assess survival outcomes (event-free survival and overall survival).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Female or male subjects, \>18 years of age, able to understand and give written informed consent
✓. Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
✓. Fit and planned for RC (according to local guidelines).
✓. ECOG performance status score of 0 or 1
✓. Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin ≥ 9 g/dL, absolute neutrophil count≥ 1,500/ mm3, and Platelets ≥ 100,000/ μL)
✓. Adequate hepatic function (Bilirubin ≤ 1.5 IULN, aspartate aminotransferase and alanine aminotransferase≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin \>3 g/dl)
✓. Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation
✓. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication, and must not be lactating. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Exclusion criteria

What they're measuring

Pathological complete response

Timeframe: After the last cycle of the investigational drug (each cycle is 21 days)

Trial details

NCT IDNCT05226117

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-24

View on ClinicalTrials.gov More Urothelial Carcinoma trials