NCT02449239: VISTA

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

Completed Phase 3 Results posted Last updated 21 July 2023

What this trial tests

Phase 3 trial testing Vicinium in Bladder Cancer in 133 participants. Completed in 1 May 2022.

Timeline

1 August 2015

Primary endpoint
1 May 2020

1 May 2022

Quick facts

Lead sponsor	Sesen Bio, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	133
Start date	1 August 2015
Primary completion	1 May 2020
Estimated completion	1 May 2022
Sites	70 locations across United States, Canada

Drugs / interventions tested

• Vicinium — full drug profile →

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Sesen Bio, Inc. — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Complete Response Rate at 3 Months
  Time frame: 3 months from start of treatment
  Complete response rate at 3 months in patients with CIS with or without resected papillary disease following initiation of Vicinium therapy. This is the percentage of patients who were free of high-grade disease at the post-induction (3 month) assessment timepoint. A patient was considered to have a complete response if the urine cytology was reported as negative or atypical AND the cystoscopy was
• Duration of Complete Response
  Time frame: Up to 24 months
  Duration of complete response in participants with CIS with or without resected papillary disease who achieved a complete response at the post-induction (3 month) assessment. This is the number of days from the date of first occurrence of complete response to the date of documented treatment failure or death, whichever occurs first

Sponsor's own description

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2020.
   Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
2. Antibodies to watch in 2019.
   Kaplon H, Reichert JM. · · 2019 · cited 324× · PMID 30516432 · DOI 10.1080/19420862.2018.1556465
3. Emerging new therapeutic antibody derivatives for cancer treatment.
   Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
4. Antibodies to watch in 2021.
   Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
5. Antibodies to watch in 2018.
   Kaplon H, Reichert JM. · · 2018 · cited 179× · PMID 29300693 · DOI 10.1080/19420862.2018.1415671
6. Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.
   Wang R, Hu B, Pan Z, Mo C, et al · · 2025 · cited 105× · PMID 40307936 · DOI 10.1186/s13045-025-01704-3
7. Immunogenicity of Immunotoxins Containing <i>Pseudomonas</i> Exotoxin A: Causes, Consequences, and Mitigation.
   Mazor R, Pastan I. · · 2020 · cited 67× · PMID 32695104 · DOI 10.3389/fimmu.2020.01261
8. Single-Chain Fragment Variable: Recent Progress in Cancer Diagnosis and Therapy.
   Muñoz-López P, Ribas-Aparicio RM, Becerra-Báez EI, Fraga-Pérez K, et al · · 2022 · cited 58× · PMID 36077739 · DOI 10.3390/cancers14174206