Trial · NCT05014139
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
NCT05014139, Phase 1, Terminated, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC). Trials, record NCT05014139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05014139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
- NCT number
- NCT05014139
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 37 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer, NMIBC
- Interventions
- Enfortumab vedotin
- First posted
- 2021-08-20
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Approximately 1 year | An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. |
| Primary | Incidence of laboratory abnormalities | Approximately 1 year | To be summarized using descriptive statistics. |
| Primary | Incidence of dose limiting toxicities (DLTs) | Approximately 7 weeks | To be summarized using descriptive statistics. |
| Secondary | Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC) | Approximately 1 year | AUC will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Maximum concentration (Cmax) | Approximately 1 year | Cmax will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Time to maximum concentration concentration (tmax) | Approximately 1 year | Tmax will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Apparent terminal half-life (t1/2) | Approximately 1 year | T1/2 will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Trough concentration (Ctrough) | Approximately 1 year | Ctrough will be recorded from the PK blood samples collected. |
| Secondary | Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin | Approximately 1 year | Blood samples for ATA analysis will be collected. |
| Secondary | Complete response (CR) rate | Up to 24 months | CR rate is defined as the proportion of subjects achieving CR. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05014139
GET https://conductscience.org/api/trials/v1/NCT05014139/registered