Trial · NCT04225117
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Cohort 9: OS | Up to 15.4 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 | Cohort 9: Number of Participants With TEAEs | Up to end of treatment + 30 day (15 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 an AE); or other medically important events. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04225117/registered