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Open-Label, Multicenter, Ph 3 [Phase 3] Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG

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Trial Profile

Open-Label, Multicenter, Ph 3 [Phase 3] Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 26 Jul 2023

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At a glance

  • Drugs Oportuzumab monatox (Primary)
  • Indications Bladder cancer; Carcinoma; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms VISTA
  • Sponsors Sesen Bio; Viventia Biotechnologies

Most Recent Events

  • 09 May 2022 In addition to working with the FDA to align on a study design, the Company has been addressing comments related to Chemistry, Manufacturing and Controls (CMC) that were included in the CRL for the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC. The Company's responses to the CMC comments will ultimately be reviewed by the FDA upon a potential BLA resubmission.
  • 09 May 2022 According to a Sesen Bio media release, company participated in a Type C Meeting during which the US FDA agreed to a majority of the proposed protocol and statistical analysis plan design elements for an additional phase III trial that it plans to conduct for resubmission of a BLA for Vicineum in NMIBC. The company plans to meet with the US FDA in mid-2022 and intends to request the meeting in the coming weeks to discuss the remaining outstanding items related to the additional phase III trial.
  • 07 Jan 2022 According to a Sesen Bio media release, the FDA granted company's request for a Type C Meeting to discuss the study protocol for an additional Phase 3 trial. The Type C Meeting has been scheduled for March 28, 2022.

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