Trial · NCT03219333
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
NCT03219333, Phase 2, Completed, Astellas Pharma Inc; results first posted 2021-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer. Trials, record NCT03219333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03219333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
- NCT number
- NCT03219333
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 219 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms, Urothelial Cancer, Ureteral Neoplasms, Urethral Neoplasms
- Interventions
- Enfortumab vedotin
- First posted
- 2017-07-17
- Last updated
- 2024-08-27
- Results first posted
- 2021-12-17
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Duration of Objective Response (DOR) Per BICR | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. DOR was analyzed using Kaplan-Meier methodology. |
| Secondary | Progression-Free Survival (PFS) Per BICR | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. |
| Secondary | ORR Per Investigator Assessment | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST 1.1. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | DOR Per Investigator Assessment | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. |
| Secondary | PFS Per Investigator Assessment | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. |
| Secondary | Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology) | The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months] | A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. |
| Secondary | Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry) | The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months] | A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based NCI CTCAE version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. |
| Secondary | Incidence of Antitherapeutic Antibody (ATA) | The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months] | Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if \>=2 consecutive samples were confirmed as positive. |
| Secondary | Disease Control Rate at 16 Weeks (DCR16) Per BICR | Up to Week 16 | Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) Per BICR | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Per BICR | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. | Months | MEDIAN |
| SECONDARY | ORR Per Investigator Assessment | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. | Percentage of Participants | NUMBER |
| SECONDARY | DOR Per Investigator Assessment | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | PFS Per Investigator Assessment | Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27) | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology) | The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months] | Safety Analysis set. Here 'Number Analyzed' for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry) | The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months] | Safety Analysis set. Here 'Number Analyzed' for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Antitherapeutic Antibody (ATA) | The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months] | Safety Analysis Set: Participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies ATA subset (participants with a baseline and at least one post-baseline sample). Here, 'Number Analyzed' signifies participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate at 16 Weeks (DCR16) Per BICR | Up to Week 16 | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. | Percentage of Participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group252
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | Enfortumab Vedotin - Cohort 1 | 44 | 95% Confidence Interval 35.1 to 53.2 | Percentage of Participants | |
| Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) | Enfortumab Vedotin - Cohort 2 | 51.7 | 95% Confidence Interval 40.8 to 62.4 | Percentage of Participants | |
| Duration of Objective Response (DOR) Per BICR | Enfortumab Vedotin - Cohort 1 | 7.6 | 95% Confidence Interval 6.34 to NA | Months | |
| Duration of Objective Response (DOR) Per BICR | Enfortumab Vedotin - Cohort 2 | 10.9 | 95% Confidence Interval 5.78 to NA | Months | |
| Progression-Free Survival (PFS) Per BICR | Enfortumab Vedotin - Cohort 1 | 5.8 | 95% Confidence Interval 4.93 to 7.46 | Months | |
| Progression-Free Survival (PFS) Per BICR | Enfortumab Vedotin - Cohort 2 | 5.8 | 95% Confidence Interval 5.03 to 8.28 | Months | |
| ORR Per Investigator Assessment | Enfortumab Vedotin - Cohort 1 | 39 | 95% Confidence Interval 30.6 to 48.3 | Percentage of Participants | |
| ORR Per Investigator Assessment | Enfortumab Vedotin - Cohort 2 | 50.6 | 95% Confidence Interval 39.8 to 61.3 | Percentage of Participants | |
| DOR Per Investigator Assessment | Enfortumab Vedotin - Cohort 1 | 7.9 | 95% Confidence Interval 5.95 to NA | Months | |
| DOR Per Investigator Assessment | Enfortumab Vedotin - Cohort 2 | 10.7 | 95% Confidence Interval 5.85 to 16.59 | Months |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enfortumab Vedotin - Cohort 1 | 128 | |
| Overall Study | STARTED | Enfortumab Vedotin - Cohort 2 | 91 | |
| Overall Study | Treated | Enfortumab Vedotin - Cohort 1 | 125 | |
| Overall Study | Treated | Enfortumab Vedotin - Cohort 2 | 89 | |
| Overall Study | COMPLETED | Enfortumab Vedotin - Cohort 1 | 0 | |
| Overall Study | COMPLETED | Enfortumab Vedotin - Cohort 2 | 0 | |
| Overall Study | NOT COMPLETED | Enfortumab Vedotin - Cohort 1 | 128 | |
| Overall Study | NOT COMPLETED | Enfortumab Vedotin - Cohort 2 | 91 |
Source ClinicalTrials.gov
Adverse events370
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 | Neutropenia | Blood and lymphatic system disorders | Enfortumab Vedotin - Cohort 1 | 13 | 125 | 22 |
| other | Neutropenia | Blood and lymphatic system disorders | Enfortumab Vedotin - Cohort 2 | 10 | 89 | 12 |
| other | Hypophosphataemia | Metabolism and nutrition disorders | Enfortumab Vedotin - Cohort 1 | 8 | 125 | 11 |
| other | Hypophosphataemia | Metabolism and nutrition disorders | Enfortumab Vedotin - Cohort 2 | 5 | 89 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Enfortumab Vedotin - Cohort 1 | 44 | 125 | 62 |
| other | Anaemia | Blood and lymphatic system disorders | Enfortumab Vedotin - Cohort 2 | 34 | 89 | 42 |
| other | Palpitations | Cardiac disorders | Enfortumab Vedotin - Cohort 1 | 1 | 125 | 1 |
| other | Palpitations | Cardiac disorders | Enfortumab Vedotin - Cohort 2 | 5 | 89 | 7 |
| other | Tachycardia | Cardiac disorders | Enfortumab Vedotin - Cohort 1 | 9 | 125 | 10 |
| other | Tachycardia | Cardiac disorders | Enfortumab Vedotin - Cohort 2 | 1 | 89 | 1 |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enfortumab Vedotin - Cohort 1 | 104 | 125 |
| Total, all-cause mortality | Enfortumab Vedotin - Cohort 2 | 72 | 89 |
| Total, other adverse events | Enfortumab Vedotin - Cohort 1 | 123 | 125 |
| Total, other adverse events | Enfortumab Vedotin - Cohort 2 | 88 | 89 |
| Total, serious adverse events | Enfortumab Vedotin - Cohort 1 | 59 | 125 |
| Total, serious adverse events | Enfortumab Vedotin - Cohort 2 | 35 | 89 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enfortumab Vedotin - Cohort 1 vs Enfortumab Vedotin - Cohort 2: deaths from any cause | Trial comparisons |
| Enfortumab Vedotin - Cohort 1 vs Enfortumab Vedotin - Cohort 2: serious adverse events | Trial comparisons |
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/NCT03219333
GET https://conductscience.org/api/trials/v1/NCT03219333/registered?page=2