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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a perioperative Phase 2, open-label, non-randomized, single-cohort study in patients with urothelial carcinoma of the bladder who cannot receive or refuse to receive cisplatin-based chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Claudia Guerrieri
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• written informed consent

• >18 years of age

• Histopathologically confirmed urothelial carcinoma.

• Fit and planned for RC ECOG performance status score of 0 or 1

• Adequate hematologic counts , hepatic and renal function.

• Negative pregnancy test and Effective contraception during the study, unless evidence of infertility exists

• Clinical stage T2-T4aN0M0 MIBC, assessed by CT + PET/CT + mpMRI.

• Ineligibility to receive cisplatin-based neoadjuvant chemotherapy based on Galsky's criteria OR refusal to receive neoadjuvant cisplatin-based chemotherapy

Exclusion Criteria:

• prior systemic anti-cancer therapy including investigational agents and immunotherapy,

• prior radiotherapy on the bladder tumor, partial cystectomy.

• Refusal to undergo RC.live vaccine, antibiotics within 30 days prior to the first dose of study drug.

• Participation in a study of an investigational agent or device, additional known malignancy , severe hypersensitivity to study drugs and/or any of their excipients, active autoimmune disease that required systemic treatment.

• history of (non-infectious) pneumonitis that required steroids or current pneumonitis.

• active chronic inflammatory bowel disease, any condition that is not in the best interest of the subject to participate, in the opinion of the treating investigator.

• active cardiac disease, defined as: A) Myocardial infarction or unstable angina pectoris within 6 months of C1D1 B) History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications; history of QT interval prolongation C) NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%

• known history of HIV-1/2 infection,

• known history of Hepatitis B

• active Hepatitis C virus infection.

• other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

• High dose systemic corticosteroids are not allowed within 2 weeks of C1D1.

• Have received or are currently receiving (within the previous 2 weeks) antibiotics.