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Studies

Interventional Active not recruiting Phase 2

NCT05535218 on ClinicalTrials.gov

Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer

Official title: SURE-02_An Open Label, Single-arm, Phase 2 Study of Perioperative Pembrolizumab Plus Sacituzumab Govitecan, and Bladder-saving Approach, for Patients With Muscle-invasive Bladder Cancer Who Cannot Receive or Refuse Cisplatin-based Chemotherapy

  • Sponsor: Claudia Guerrieri
  • Enrollment: 48 (Estimated)
  • Study start: 2023-09-20 (Actual)
  • Primary completion: 2027-02-01 (Estimated)
  • Study completion: 2027-02-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Muscle-invasive Urothelial Carcinoma of the Bladder

Intervention / Treatment

  • Drug: Sacituzumab govitecan is a humanized mAb with a hydrolysable linker through which SN-38 is conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- expressing tumors, whi

Primary Outcome Measures

  • Clinical CR-rate (36 months)
    To assess whether sacituzumab govitecan plus pembrolizumab is an effective perioperative strategy in patients with clinical T2-3bN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy.

Countries

Italy

Locations and Investigators

  • Ospedale San Raffaele S.r.l., Milan, Italy
    • Andrea, Necchi

Study Officials