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Virus Therapy

Vicinium for Bladder Cancer (VISTA Trial)

Phase 3
Waitlist Available
Research Sponsored by Viventia Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants on treatment were assessed at months 6, 9, 12, 15,18, 21, and 24
Awards & highlights

VISTA Trial Summary

This trial is testing an experimental agent, Vicinium, as an alternative to cystectomy for people with high-risk bladder cancer.

Eligible Conditions
  • Bladder Cancer

VISTA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants on treatment were assessed at months 6, 9, 12, 15,18, 21, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants on treatment were assessed at months 6, 9, 12, 15,18, 21, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response Rate at 3 Months
Duration of Complete Response
Secondary outcome measures
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
Event-free Survival
Number of Participants That Discontinued Study Treatment Due to an AE
+5 more

Side effects data

From 2022 Phase 3 trial • 133 Patients • NCT02449239
35%
Urinary tract infection
28%
Dysuria
26%
Haematuria
17%
Micturition urgency
17%
Pollakiuria
16%
Fatigue
13%
Diarrhoea
12%
Nausea
11%
Oedema peripheral
10%
Nasopharygitis
9%
Lipase increased
8%
Constipation
8%
Urinary incontinence
8%
Upper respiratory tract infection
8%
Cough
8%
Hypertension
7%
Arthralgia
6%
Pyrexia
6%
Headache
6%
Bladder spasm
5%
Abdominal pain
5%
Vomiting
5%
Amylase increased
5%
Back pain
2%
Small intestinal obstruction
2%
Acute kidney injury
1%
Oesophageal obstruction
1%
Hepatitis cholestasis
1%
Cystitis
1%
Rib fracture
1%
Lung neoplasm malignant
1%
Cerebrovascular accident
1%
Renal failure
1%
Urinary retention
1%
Pelvic pain
1%
Asthma
1%
Aortic valve disease
1%
Pyelonephritis
1%
Fall
1%
Pericardial effusion
1%
Tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vicinium

VISTA Trial Design

1Treatment groups
Experimental Treatment
Group I: ViciniumExperimental Treatment1 Intervention
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oportuzumab monatox
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Viventia BioLead Sponsor
4 Previous Clinical Trials
241 Total Patients Enrolled
Sesen Bio, Inc.Lead Sponsor
4 Previous Clinical Trials
241 Total Patients Enrolled
Minori K Rosales, M.D., Ph.D.Study DirectorSesen Bio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
2015. "Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02449239.
~14 spots leftby Apr 2025
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