muscle-invasive bladder cancer MedDRA version: 20.0 Level: LLT Classification code 10046714 Term: Urothelial carcinoma bladder System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10046714 Term: Urothelial carcinoma bladder System Organ Class: 100000004864
Conditions
Interventions
Trade Name: KEYTRUDA (Pembrolizumab, MK-3475)
Product Name: Pembrolizumab
Product Code: [NA]
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PEMBROLIZUMAB
CAS Number: 1374853-91-4
Cur
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether sacituzumab govitecan plus pembrolizumab results in pathological complete response (herein referred to as either “pT0” or “pCR”) in patients with clinical T2-4aN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy;Secondary Objective: To evaluate the safety and tolerability of sacituzumab govitecan+pembrolizumab in patients with high-risk organ-confined cancer;Primary end point(s): Number of complete pathological responses, defined as the absence of viable tumor cells on the histological examination of the cystectomy.;Timepoint(s) of evaluation of this end point: to the cystectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability evaluation of the treatment: Number of patients who experienced adverse events. Type, frequency, severity and correlation to treatment of adverse events, assessed according to the Common Toxicity Criteria for adverse events (CTCAE) v 5.0. Progression-free survival (PFS). Overall survival (OS).;Timepoint(s) of evaluation of this end point: until 12 months post adiuvant Pembrolizumab treatment | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Fullcro S.r.l.
Outcome results
None listed