TriangleNCT03219333 · STUDY IN CONTEXT
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- trial label
- A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0000
- source section id
- NCT03219333-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0001
- source section id
- NCT03219333-om-0001
- source outcome index
- 1
- endpoint
- Duration of Objective Response (DOR) Per BICR
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0002
- source section id
- NCT03219333-om-0002
- source outcome index
- 2
- endpoint
- Progression-Free Survival (PFS) Per BICR
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0003
- source section id
- NCT03219333-om-0003
- source outcome index
- 3
- endpoint
- ORR Per Investigator Assessment
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0004
- source section id
- NCT03219333-om-0004
- source outcome index
- 4
- endpoint
- DOR Per Investigator Assessment
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0005
- source section id
- NCT03219333-om-0005
- source outcome index
- 5
- endpoint
- PFS Per Investigator Assessment
- endpoint definition
- 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.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Enfortumab Vedotin - Cohort 1
- regimen
- Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 125
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Enfortumab Vedotin - Cohort 2
- regimen
- Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 89
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Enfortumab Vedotin - Cohort 1
- regimen
- Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Enfortumab Vedotin - Cohort 2
- regimen
- Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 46
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Enfortumab Vedotin - Cohort 1
- regimen
- Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 125
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Enfortumab Vedotin - Cohort 2
- regimen
- Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 89
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Enfortumab Vedotin - Cohort 1
- regimen
- Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 125
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Enfortumab Vedotin - Cohort 2
- regimen
- Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 89
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Enfortumab Vedotin - Cohort 1
- regimen
- Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 49
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Enfortumab Vedotin - Cohort 2
- regimen
- Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Enfortumab Vedotin - Cohort 1
- regimen
- Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 125
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Enfortumab Vedotin - Cohort 2
- regimen
- Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
- analyzed count
- 89
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03219333-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- harm key
- EG000
- source section id
- NCT03219333-ae
- event group key
- EG000
- event group label
- Enfortumab Vedotin - Cohort 1
- serious affected
- 59
- serious at risk
- 125
- other affected
- 123
- other at risk
- 125
- frequency threshold
- 5
- collection period
- Cohort 1: maximum up to 62.36 months of follow-up; Cohort 2: maximum up to 48.95 months of follow-up
- event definition
- Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-bavencio-16fb7ea9
- nct id
- NCT03219333
- harm key
- EG001
- source section id
- NCT03219333-ae
- event group key
- EG001
- event group label
- Enfortumab Vedotin - Cohort 2
- serious affected
- 35
- serious at risk
- 89
- other affected
- 88
- other at risk
- 89
- frequency threshold
- 5
- collection period
- Cohort 1: maximum up to 62.36 months of follow-up; Cohort 2: maximum up to 48.95 months of follow-up
- event definition
- Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice