Trial · NCT03474107
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
NCT03474107, Phase 3, Completed, Astellas Pharma Global Development, Inc.; results first posted 2021-08-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301). Trials, record NCT03474107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03474107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
- NCT number
- NCT03474107
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 608 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Ureteral Cancer, Urothelial Cancer, Bladder Cancer
- Interventions
- Enfortumab Vedotin, Docetaxel, Vinflunine, Paclitaxel
- First posted
- 2018-03-22
- Last updated
- 2026-01-09
- Other registries' IDs
- eudract:2017-003344-21
- Results first posted
- 2021-08-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | OS was defined as the time from the date of randomization until the documented date of death from any cause. OS was analyzed using Kaplan-Meier estimates. Participants who were still alive at the time of data cutoff date were to be censored at the last known alive date or at the data cutoff date, whichever was earlier. |
| Secondary | Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | PFS: time from date of randomization until date of documented radiological disease progression (PD) per investigator based on RECIST V1.1, or until death due to any cause, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions taking as reference the smallest sum, and sum must also demonstrate an absolute increase of \>= 5 mm. Appearance of 1 or more new lesions is also considered progression. A participant who neither progressed nor died was censored at date of last radiological assessment (RA)/ date of randomization if no post-baseline RA was available. Participants who received any further anticancer therapy (ACT) for disease before radiological progression was censored at date of last RA before ACT started and participants who had PD/death after \>=2 missed RAs were censored at last RA prior to 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow-up for PFS was based on data cut-off \& is same as median follow-up time for OS. |
| Secondary | Overall Response Rate (ORR) as Per RECIST V1.1 | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. ORR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for ORR was based on data cut-off and is same as median follow-up time for OS. |
| Secondary | Disease Control Rate (DCR) as Per RECIST V1.1 | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | DCR was defined as the percentage of participants with a CR, PR or a stable disease (SD) based on RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. Progressive disease is defined in PFS1 endpoint. DCR was analysed using exact method based on binomial distribution (Clopper-Pearson). Median time of follow up for DCR was based on data cut-off and is same as median follow-up time for OS. |
| Secondary | Duration of Response (DOR) as Per RECIST V1.1 | From date of first objective response until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | DOR: time from the date of the first CR/PR (whichever is first recorded) that was subsequently confirmed as assessed by investigator to the date of documented PD or death due to any cause whichever occurred first. If a participant has neither progressed nor died, the participant was censored at the date of last RA or at the date of first CR/PR if no subsequent post-baseline RA was available. Participants who received any further ACT for the disease before radiological progression were censored at the date of the last RA before the ACT started. In addition, participants who had PD/death after \>= 2 missed RAs were censored at the last RA prior to the 2 or more missed RAs. Kaplan-Meier estimates was used. Median time of follow up for DOR was based on data cut-off and is same as median follow-up time for OS. CR/PR and PD were defined in ORR and PFS1 endpoints, respectively. |
| Secondary | Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score) | Baseline and week 12 | EORTC QLQ-C30 is a generic questionnaire consisting of 30 items. The instrument yields functional scales (physical, role, emotional, cognitive, social), symptom scales/items (fatigue, Nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea), global health status, and financial impact score. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). The recall period for each question is "during the past week". All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. Higher scores on the global health status and functioning scales indicate better health status/function. |
| Secondary | Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) | Baseline and week 12 | EQ-5D-5L is a health status instrument for self-reported assessment of 5 domains of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is rated by selecting 1 of 5 standardized categorizations ranging from no problem to extreme problem. The final question is a visual analogue scale (VAS) to rank health status from 0 (best health imaginable) to 100 (worst health imaginable). |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | From first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group) | An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is defined as an AE observed or worsened after starting administration of the study drug. |
| Secondary | Number of Participants With ECOG Performance Status | End of treatment (EOT) (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group) | ECOG performance status was measured on an 6 point scale. 0-Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. Dead. Number of participants with ECOG PS was reported. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | FAS Population | months | MEDIAN |
| SECONDARY | Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | FAS Population | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) as Per RECIST V1.1 | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | Response Evaluable Set (RES): The RES was defined as all participants in the FAS who had measurable disease (per RECIST v1.1) per investigator at baseline. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) as Per RECIST V1.1 | From randomization until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | RES Population | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Per RECIST V1.1 | From date of first objective response until the analysis cut-off date of 15-Jul-2020 (median OS follow-up was 11.10 months) | RES population with available data. | months | MEDIAN |
| SECONDARY | Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score) | Baseline and week 12 | FAS population with available data. | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) | Baseline and week 12 | FAS population with available data. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | From first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group) | The safety analysis set (SAF) consisted of all participants who received any amount of study drug, and was used for safety analyses. | participants | NUMBER |
| SECONDARY | Number of Participants With ECOG Performance Status | End of treatment (EOT) (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group) | Safety population with available data. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Enfortumab Vedotin 1.25 mg/kg | 12.88 | 95% Confidence Interval 10.58 to 15.21 | months | |
| Overall Survival (OS) | Chemotherapy | 8.97 | 95% Confidence Interval 8.05 to 10.74 | months | |
| Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Enfortumab Vedotin 1.25 mg/kg | 5.55 | 95% Confidence Interval 5.32 to 5.82 | months | |
| Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Chemotherapy | 3.71 | 95% Confidence Interval 3.52 to 3.94 | months | |
| Overall Response Rate (ORR) as Per RECIST V1.1 | Enfortumab Vedotin 1.25 mg/kg | 40.6 | 95% Confidence Interval 34.90 to 46.54 | percentage of participants | |
| Overall Response Rate (ORR) as Per RECIST V1.1 | Chemotherapy | 17.9 | 95% Confidence Interval 13.71 to 22.76 | percentage of participants | |
| Disease Control Rate (DCR) as Per RECIST V1.1 | Enfortumab Vedotin 1.25 mg/kg | 71.9 | 95% Confidence Interval 66.30 to 76.99 | percentage of participants | |
| Disease Control Rate (DCR) as Per RECIST V1.1 | Chemotherapy | 53.4 | 95% Confidence Interval 47.52 to 59.17 | percentage of participants | |
| Duration of Response (DOR) as Per RECIST V1.1 | Enfortumab Vedotin 1.25 mg/kg | 7.39 | 95% Confidence Interval 5.59 to 9.46 | months | |
| Duration of Response (DOR) as Per RECIST V1.1 | Chemotherapy | 8.11 | 95% Confidence Interval 5.65 to 9.56 | months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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 1.25mg/kg | 301 | |
| Overall Study | STARTED | Chemotherapy | 307 | |
| Overall Study | Treated | Enfortumab Vedotin 1.25mg/kg | 296 | |
| Overall Study | Treated | Chemotherapy | 291 | |
| Overall Study | COMPLETED | Enfortumab Vedotin 1.25mg/kg | 56 | |
| Overall Study | COMPLETED | Chemotherapy | 22 | |
| Overall Study | NOT COMPLETED | Enfortumab Vedotin 1.25mg/kg | 245 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 285 |
Source ClinicalTrials.gov
Adverse events494
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 | Anaemia | Blood and lymphatic system disorders | Enfortumab Vedotin | 57 | 296 | 98 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy | 83 | 291 | 136 |
| other | Neutropenia | Blood and lymphatic system disorders | Enfortumab Vedotin | 16 | 296 | 30 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy | 20 | 291 | 37 |
| other | Dry eye | Eye disorders | Enfortumab Vedotin | 19 | 296 | 24 |
| other | Dry eye | Eye disorders | Chemotherapy | 3 | 291 | 3 |
| other | Lacrimation increased | Eye disorders | Enfortumab Vedotin | 30 | 296 | 37 |
| other | Lacrimation increased | Eye disorders | Chemotherapy | 12 | 291 | 15 |
| other | Vision blurred | Eye disorders | Enfortumab Vedotin | 16 | 296 | 20 |
| other | Vision blurred | Eye disorders | Chemotherapy | 5 | 291 | 5 |
1 to 10 of 494Source ClinicalTrials.gov
See all 494 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enfortumab Vedotin | 130 | 296 |
| Total, all-cause mortality | Chemotherapy | 161 | 291 |
| Total, other adverse events | Enfortumab Vedotin | 284 | 296 |
| Total, other adverse events | Chemotherapy | 266 | 291 |
| Total, serious adverse events | Enfortumab Vedotin | 138 | 296 |
| Total, serious adverse events | Chemotherapy | 128 | 291 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enfortumab Vedotin 1.25 mg/kg vs Chemotherapy: Number of Participants With Treatment Emergent Adverse Events | Trial comparisons |
| Enfortumab Vedotin vs Chemotherapy: deaths from any cause | Trial comparisons |
| Enfortumab Vedotin vs Chemotherapy: 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/NCT03474107
GET https://conductscience.org/api/trials/v1/NCT03474107/results?page=2