Upstate Active Clinical Trials

Study Title:

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination with Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) who are Ineligible for or Elected Not to Undergo Radical Cystectomy

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/device (gemcitabine/TAR-200) alone, cetrelimab alone, or TAR-200 in combination with cetrelimab is safe and decreases the number of bladder cancer cells in patients with non-muscle invasive bladder cancer (NMIBC).

Upstate Institutional Review Board (IRB) Number:

1710949

Study/Protocol ID:

17000139BLC2001

Study Phase:

IIb

Patient Age Group:

Adults

Principal Investigator:

Joseph M Jacob, MD

What is involved if I participate?

• How long is the study?
  If you join the study, you may receive treatment for up to 2 years and you may be followed for up to 5 years.
• Is transportation provided or reimbursed?
  Yes
• Is parking provided or reimbursed?
  Yes
• What tests and procedures are involved?
  Physical exams, blood tests, ECG, CT/MRI scans, urine cytology, cystoscopy, TURBT

Where will the study take place?

Upstate Cancer Center, Urology Clinic at 550 Harrison Center

ClinicalTrials.Gov ID:

NCT04640623

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Nicholas Carusone, BS
Phone: 315-464-5296
Email: carusonn@upstate.edu

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