The VISTA trial is an open-label, multicentre, single-arm Phase three clinical trial assessing the efficacy and tolerability of Vicinium as a monotherapy in patients with high-risk, bacillus Calmette-Guerin
, or BCG, unresponsive NMIBC.
* Describe surveillance data, demographics, and epidemiology of bacillus Calmette-Guerin
(BCG) cases and tuberculosis (TB) cases reported to the National TB Surveillance System (NTSS) during 2004 to 2015.
(BCG) vaccine contains attenuated bacteria and its use within the bladder was first described by Morales in 1976 (10).
Sesen Bio reported 'positive' preliminary efficacy data for the primary endpoint of its ongoing Phase 3 registration trial, the VISTA Trial, of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guerin
and deemed BCG-unresponsive.
"For higher risk non-muscleinvasive cases, patients may be offered a second TURBT operation, a Bacillus Calmette-Guerin
(BCG) vaccine which is passed into your bladder through a catheter and left for one hour before being drained away, or an operation to remove your bladder completely, otherwise known as a cystectomy."
BCG is an abbreviation of Bacillus Calmette-Guerin
, meaning the bacilli of Calmette and Guerin.
Clinical characteristics and needle aspiration management of Bacillus Calmette-Guerin
lymphadenitis in children.
In that phase 3 clinical trial, patients had resection of up to five sites of metastatic disease and were then randomized to one of two treatment arms: bacillus Calmette-Guerin
and allogeneic whole-cell vaccine (Canvaxin) or bacillus Calmette-Guerin
Success rates increased with intravesical Bacillus Calmette-Guerin
(BCG) therapy used in 1976 for the first time (10).
The Bacillus Calmette-Guerin
(BCG) vaccine is recommended for healthy babies, to be administered as soon as possible after they're born.
(1) In addition to resection, Bacillus Calmette-Guerin
(BCG) intravesical immunotherapy is well-described, with Level 1 evidence demonstrating benefit in preventing recurrence and progression of NMIBC; (2,3) however, BCG treatment is not benign and carries risk of significant adverse effects.
(BCG) is a viable strain of the virulent Mycobacterium bovis.