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A Single-Arm, Open-Label, Multicenter, Phase II Clinical Study to Evaluate the Tolerability, Safety, and Preliminary Efficacy of Intravesical Administration of Herpes Virus T3011 Injection in Participants with BCG-unresponsive High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC).

Primary:
To evaluate the safety of T3011 via intravesical instillation in participants with BCG unresponsive non-muscle-invasive bladder cancer (NMIBC) and confirm RP2D.

Secondary:
To evaluate the efficacy of T3011 via intravesical instillation in participants with BCG unresponsive NMIBC.

Protocol Number: 082504
Phase: Phase II
Applicable Disease Sites: Urinary Bladder
Drugs Involved: T3011
Principal Investigator: Vignesh Packiam
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.