Upstate Active Clinical Trials
Study Title:A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
What is the purpose of the study? (in Layman's terms, please describe the study)The purpose of this study is to see if an investigational drug delivery system (gemcitabine/TAR-200) in combination with intravenous cetrelimab and intravenous cetrelimab alone can improve the results of radical cystectomy for patients with muscle invasive bladder cancer who are unable to receive pre-operative platinum chemotherapy. Prior studies (Grossman 2013) suggest a benefit of chemotherapy prior to radical cystectomy. We are studying if TAR-200 and cetrelimab can provide a similar benefit to pre-operative chemotherapy.
Upstate Institutional Review Board (IRB) Number:1916226
Patient Age Group:Adults
Principal Investigator:Joseph M Jacob, MD
What is involved if I participate?
- How long is the study?
If all visits are completed, participation will last approximately 27 months.
- Is transportation provided or reimbursed?
- Is parking provided or reimbursed?
- What tests and procedures are involved?
Physical exams with vital signs, blood work, EKGs, Questionnaires, CT scans, cystoscopy, radical cystectomy
Where will the study take place?SUNY Upstate Medical University Community Campus, SUNY Upstate Medical University Downtown Campus, Upstate Specialty Services at Harrison Center
Other Information:Treatment will consist of either 4 cycles of Cetrelimab alone or TAR-200 + Cetrelimab. Each cycle is 3 weeks long. TAR-200 is given into the bladder while Certelimab is given by IV administration.
Who can I contact for more information?
Name: Nicholas Carusone, BS