SURE-01_An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Sacituzumab Govitecan, Before Radical Cystectomy, for Patients With Muscleinvasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy
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).
• 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
• Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>2 years
⁃ Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study therapy.
⁃ Clinical stage defining clinical T2-T4N0M0 disease by CT (or MRI) + PET/CT (within 4 weeks of randomization by RECIST v1.1).
⁃ The patient accepts to undergo radical cystectomy.
⁃ Ineligibility to receive cisplatin-based neoadjuvant chemotherapy based on Galsky's criteria OR refusal to receive neoadjuvant cisplatin-based chemotherapy.