Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer (NCT05535218) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer
Italy48 participantsStarted 2023-09-20
Plain-language summary
This is a Phase 2, single-center, open-label, non-randomized study in patients with MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy.
Patients will be consecutively enrolled and treated. All patients enrolled who receive at least 1 cycle of study drug will be included in the primary and secondary endpoint analyses.
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.
✓. Refusal of unsuitability for standard chemoradiotherapy protocols.
✓. Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin ≥ 9 g/dL, ANC ≥ 1,500/ mm3, and Platelets
✓. Adequate hepatic function (Bilirubin ≤ 1.5 IULN, AST and ALT ≤ 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
Exclusion criteria
✕. Have received prior systemic anti-cancer therapy including investigational agents and immunotherapy.
✕. Have received prior radiotherapy on the bladder tumor.
✕. Have received any antibiotics within 30 days prior to the first dose of study drug.
✕. Are currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
✕. Have a known additional malignancy that is progressing or has required active treatment within the past 3 years.