Trial · NCT03219333
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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 |
| SECONDARY | DCR16 Per Investigator Assessment | Up to Week 16 | Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival (OS): Primary Analysis | Cohort 1 median follow-up time: 28.4 months [range 0.49, 32.62]; Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27] | Full analysis set: included all enrolled participants who received at least one dose of enfortumab vedotin. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs): Primary Analysis | 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: includes all participants who received at least one dose of enfortumab vedotin. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK) Parameter for Enfortumab Vedotin: Maximum Concentration (Cmax) (Serum) | Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22 | PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints. | Microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum) | Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22 | PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints. | Days | MEDIAN |
| SECONDARY | PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum) | AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose) | PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints. | Day*microgram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (Plasma) | Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22 | PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints. | Nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter for Free MMAE: Tmax (Plasma) | Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22 | PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints. | Days | MEDIAN |
| SECONDARY | PK Parameter for Free MMAE: AUC (Plasma) | AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose) | PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints. | Day*nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter for Total Antibody (TAb): Cmax (Serum) | Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22 | PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints. | Microgram per milliliter | GEOMETRIC_MEAN |
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.
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