Trial · NCT02449239
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
NCT02449239, Phase 3, Completed, Sesen Bio, Inc.; results first posted 2023-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG. Trials, record NCT02449239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02449239
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
- NCT number
- NCT02449239
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 133 participants, actual
- Lead sponsor
- Sesen Bio, Inc.
- Conditions
- Bladder Cancer
- Interventions
- Vicinium
- First posted
- 2015-05-20
- Last updated
- 2023-07-24
- Results first posted
- 2023-07-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate at 3 Months | 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 reported as normal or any suspicious areas were deemed negative for high-grade disease upon biopsy assessment. |
| Primary | Duration of Complete Response | 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 |
| Secondary | Event-free Survival | Up to 24 months | Interval from the date of first dose of study treatment to the first event (persistent high-grade disease or low grade T1 if that was the baseline disease, high-grade disease tumor recurrence, tumor progression to muscle invasive bladder cancer, cystectomy due to treatment failure, or death) prior to treatment discontinuation |
| Secondary | Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Participants on treatment were assessed at months 6, 9, 12, 15,18, 21, and 24 | Complete response rate in subjects with CIS with or without resected papillary disease after 6, 9, 12, 15, 18, 21, and 24 months of Vicinium therapy. This is measured as a proportion of the total number of participants in this group that are free of high-grade disease at the respective 3-month intervals |
| Secondary | Time to Cystectomy | Up to 48 months | Time from the date of first dose of study treatment to physical removal of the bladder |
| Secondary | Time to Disease Recurrence | Up to 24 months | Time from the first dose of study treatment to the first occurrence of treatment failure or death on or prior to treatment discontinuation for participants with papillary disease only |
| Secondary | Progression-free Survival | Up to 24 months | Time from the date of first dose of study treatment to the date of disease progression (e.g., T2 or more advanced disease) or death on or prior to treatment discontinuation |
| Secondary | Overall Survival | Up to 48 months (up to 24 months while on study treatment and up to 24 months in the post-treatment follow-up period from the date of last dose of study drug) | All participants were followed for survival during the period of consent (up to 24 months of study treatment and up to 24 months after last dose of study treatment). Any participants who were alive at last follow-up were censored. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to 25 months (up to 24 months of study treatment + 30 days after the last dose of study drug) | An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could, therefore, be any unfavorable and unintended sign (that may include an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Any worsening of the participant's pre-existing medical conditions was also considered an AE, unless it was within the normal range of disease fluctuation for that participant. |
| Secondary | Number of Participants That Discontinued Study Treatment Due to an AE | Up to 24 months | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could, therefore, be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate at 3 Months | 3 months from start of treatment | Patients with CIS with or without concomitant papillary (Ta or T1) disease | percentage of participants | NUMBER |
| PRIMARY | Duration of Complete Response | Up to 24 months | Participants with CIS with or without concomitant papillary (Ta or T1) disease who achieved a complete response at 3 months | days | MEDIAN |
| SECONDARY | Event-free Survival | Up to 24 months | days | MEDIAN | |
| SECONDARY | Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Participants on treatment were assessed at months 6, 9, 12, 15,18, 21, and 24 | Participants with CIS with or without concomitant papillary (Ta or T1) disease | percentage of participants | NUMBER |
| SECONDARY | Time to Cystectomy | Up to 48 months | days | MEDIAN | |
| SECONDARY | Time to Disease Recurrence | Up to 24 months | Participants with high-grade Ta or T1 papillary disease | days | MEDIAN |
| SECONDARY | Progression-free Survival | Up to 24 months | days | MEDIAN | |
| SECONDARY | Overall Survival | Up to 48 months (up to 24 months while on study treatment and up to 24 months in the post-treatment follow-up period from the date of last dose of study drug) | days | MEDIAN | |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to 25 months (up to 24 months of study treatment + 30 days after the last dose of study drug) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Discontinued Study Treatment Due to an AE | Up to 24 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate at 3 Months | Vicinium | 39 | 95% Confidence Interval 29 to 49 | percentage of participants | |
| Duration of Complete Response | Vicinium | 273.0 | 95% Confidence Interval 155.0 to NA | days | |
| Event-free Survival | Vicinium | 90.5 | 95% Confidence Interval 81.0 to 179.0 | days | |
| Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Vicinium | 6 months | 28 | 95% Confidence Interval 19 to 38 | percentage of participants |
| Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Vicinium | 9 months | 19 | 95% Confidence Interval 12 to 29 | percentage of participants |
| Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Vicinium | 12 months | 16 | 95% Confidence Interval 9 to 25 | percentage of participants |
| Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Vicinium | 15 months | 14 | 95% Confidence Interval 8 to 23 | percentage of participants |
| Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Vicinium | 18 months | 14 | 95% Confidence Interval 8 to 23 | percentage of participants |
| Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Vicinium | 21 months | 13 | 95% Confidence Interval 7 to 21 | percentage of participants |
| Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months | Vicinium | 24 months | 12 | 95% Confidence Interval 6 to 20 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase | STARTED | Vicinium | 133 | |
| Induction Phase | COMPLETED | Vicinium | 63 | |
| Induction Phase | NOT COMPLETED | Vicinium | 70 | |
| Maintenance Month 3 | STARTED | Vicinium | 63 | |
| Maintenance Month 3 | COMPLETED | Vicinium | 49 | |
| Maintenance Month 3 | NOT COMPLETED | Vicinium | 14 | |
| Maintenance Month 6 | STARTED | Vicinium | 49 | |
| Maintenance Month 6 | COMPLETED | Vicinium | 36 | |
| Maintenance Month 6 | NOT COMPLETED | Vicinium | 13 | |
| Maintenance Month 9 | STARTED | Vicinium | 36 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Vicinium | 17 | 133 | 25 |
| other | Nausea | Gastrointestinal disorders | Vicinium | 16 | 133 | 20 |
| other | Constipation | Gastrointestinal disorders | Vicinium | 11 | 133 | 18 |
| other | Abdominal pain | Gastrointestinal disorders | Vicinium | 7 | 133 | 12 |
| other | Vomiting | Gastrointestinal disorders | Vicinium | 7 | 133 | 7 |
| other | Fatigue | General disorders | Vicinium | 21 | 133 | 24 |
| other | Oedema peripheral | General disorders | Vicinium | 15 | 133 | 16 |
| other | Pyrexia | General disorders | Vicinium | 8 | 133 | 10 |
| other | Urinary tract infection | Infections and infestations | Vicinium | 46 | 133 | 100 |
| other | Nasopharygitis | Infections and infestations | Vicinium | 13 | 133 | 16 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vicinium | 13 | 133 |
| Total, other adverse events | Vicinium | 114 | 133 |
| Total, serious adverse events | Vicinium | 21 | 133 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02449239
GET https://conductscience.org/api/trials/v1/NCT02449239/flow?page=2