EUCTR2020-004876-16-ITActive, not recruitingPhase 1
SURE-02_An open label, single-arm, phase 2 study of perioperative pembrolizumab plus sacituzumab govitecan for patients with muscle-invasive bladder cancer who cannot receive or refuse cisplatin-based chemotherapy - SURE-02
OSPEDALE SAN RAFFAELE0 sites48 target enrollmentStarted: August 30, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
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.
- •Partecipation 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:
- •Myocardial infarction or unstable angina pectoris within 6 months of C1D1
- •History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications; history of QT interval prolongation
- •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 or known 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.
Investigators
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