Trial · NCT04225117
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
NCT04225117, Phase 2, Active not recruiting, Astellas Pharma Global Development, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202). Trials, record NCT04225117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04225117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
- NCT number
- NCT04225117
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 329 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Locally Advanced or Metastatic Malignant Solid Tumors
- Interventions
- enfortumab vedotin, pembrolizumab
- First posted
- 2020-01-13
- Last updated
- 2026-09-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment | Up to 20.04 months | Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson). |
| Primary | Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment | Up to 12.85 months | Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson). |
| Secondary | Cohorts 1-8: Duration of Resonse (DOR) Per RECIST V.1.1 Per Investigator Assessment | Up to 20.04 months | DOR was defined as the time from the date of first documented response (CR or PR that is subsequently confirmed) to the date of first documented progressive disease (PD) per RECIST V1.1 or death due to any cause, whichever occurs first. DOR was only calculated for participants achieving a confirmed CR or PR, based on Kaplan-Meier estimate. |
| Secondary | Cohorts 1-8: Disease Control Rate (DCR) Per RECIST V1.1 Per Investigator Assessment | Up to 22 months | DCR was defined as the percentage of participants whose Best Overall Response (BOR) was confirmed CR or PR or stable disease (SD) (≥ 7 weeks). |
| Secondary | Cohorts 1-8: Progression Free Survival (PFS) Per RECIST V1.1 Per Investigator Assessment | Up to 22 months | PFS was defined as the time from start of study intervention to first documentation of objective tumor progression or death due to any cause, whichever comes first, based on Kaplan-Meier estimate. |
| Secondary | Cohorts 1-8: Overall Survival (OS) | Up to 34 months | OS was defined as the time from start of study treatment to date of death due to any cause, based on Kaplan-Meier estimate. In the absence of confirmed death, OS was censored at the last date the participant was known to be alive. |
| Secondary | Cohorts 1-8: Number of Participants With Treatment-emergent Adverse Events (AEs) | Up to end of treatment + 30 days (32 months) | A TEAE is any untoward medical occurrence in a participant administered enfortumab vedotin, and which does not necessarily have to have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of enfortumab vedotin whether or not considered related to the enfortumab vedotin. A TEAE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by a TEAE); or other medically important events. |
| Secondary | Cohort 9: DOR Per RECIST V.1.1 Per Investigator Assessment | Up to 12.85 months | DOR was defined as the time from the date of first documented response (CR or PR that is subsequently confirmed) to the date of first documented PD per RECIST V1.1 or death due to any cause, whichever occurs first. DOR was only calculated for participants achieving a confirmed CR or PR, based on Kaplan-Meier estimate. |
| Secondary | Cohort 9: DCR Per RECIST V1.1 Per Investigator Assessment | Up to 15 months | DCR was defined as the percentage of participants whose BOR is confirmed CR or PR or SD (≥ 7 weeks). |
| Secondary | Cohort 9: PFS Per RECIST V1.1 by Investigator Assessment | Up to 15 months | PFS was defined as the time from start of study intervention to first documentation of objective tumor progression or death due to any cause, whichever comes first, based on Kaplan-Meier estimate. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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 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/NCT04225117
GET https://conductscience.org/api/trials/v1/NCT04225117/registered