A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemothe

Draft scope assessment: unclear. Attached because the study's own record names PD-L1 and 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

ORR was defined as the percentage of participants with best overall response (BOR) as 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.

FAS population

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primary · POSTED

Cmax was derived from the PK blood samples collected.

Pharmacokinetic Analysis Set (PKAS) included all participants in the PK cohort who had received at least 3 of 4 doses up through Cycle 2 Day 1, and had at least 5 blood samples collected and assayed for measurement of ADC, TAb or unconjugated MMAE serum/plasma concentrations to determine at least 1 PK parameter.

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primary · POSTED

Cmax was derived from the PK blood samples collected.

PKAS population.

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primary · POSTED

Cmax was derived from the PK blood samples collected.

PKAS population with available data were analyzed.

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primary · POSTED

Cmax was derived from the PK blood samples collected.

PKAS population with available data were analyzed.

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primary · POSTED

As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.

PKAS population.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-tecentriq-e0f5bc9f
nct id: NCT04995419
trial label: A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemothe
applicability: unclear
applicability note: Attached because the study's own record names PD-L1 and 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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0000
source section id
NCT04995419-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors V1.1 (RECIST V1.1)
endpoint definition
ORR was defined as the percentage of participants with best overall response (BOR) as 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.
time origin
From first dose up to progressive disease or death (maximum duration: 9.33 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
FAS population
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-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0001
source section id
NCT04995419-om-0001
source outcome index
1
endpoint
Pharmacokinetics (PK) of Antibody-Drug Conjugate (ADC), Total Antibody (TAb), in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1
endpoint definition
Cmax was derived from the PK blood samples collected.
time origin
Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic Analysis Set (PKAS) included all participants in the PK cohort who had received at least 3 of 4 doses up through Cycle 2 Day 1, and had at least 5 blood samples collected and assayed for measurement of ADC, TAb or unconjugated MMAE serum/plasma concentrations to determine at least 1 PK parameter.
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-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0002
source section id
NCT04995419-om-0002
source outcome index
2
endpoint
PK of Monomethyl Auristatin E (MMAE) in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 1
endpoint definition
Cmax was derived from the PK blood samples collected.
time origin
Cycle 1 Day 1: pre-dose, end of infusion (EOI), 2 hour, 4 hour post-dose (each cycle = 28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
PKAS population.
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-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0003
source section id
NCT04995419-om-0003
source outcome index
3
endpoint
PK of ADC, TAb in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15
endpoint definition
Cmax was derived from the PK blood samples collected.
time origin
Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
PKAS population with available data were analyzed.
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-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0004
source section id
NCT04995419-om-0004
source outcome index
4
endpoint
PK of MMAE in Serum: Maximum Concentration (Cmax) at Cycle 1 Day 15
endpoint definition
Cmax was derived from the PK blood samples collected.
time origin
Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
PKAS population with available data were analyzed.
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-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0005
source section id
NCT04995419-om-0005
source outcome index
5
endpoint
PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1
endpoint definition
As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.
time origin
Cycle 1 Day 1: pre-dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
PKAS population.
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-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0000
arm key
OG000
arm label
Enfortumab Vedotin 1.25 mg/kg
regimen
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04995419-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0001
arm key
OG000
arm label
Enfortumab Vedotin 1.25 mg/kg
regimen
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04995419-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0002
arm key
OG000
arm label
Enfortumab Vedotin 1.25 mg/kg
regimen
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04995419-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0003
arm key
OG000
arm label
Enfortumab Vedotin 1.25 mg/kg
regimen
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04995419-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0004
arm key
OG000
arm label
Enfortumab Vedotin 1.25 mg/kg
regimen
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04995419-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-e0f5bc9f
nct id
NCT04995419
outcome key
om-0005
arm key
OG000
arm label
Enfortumab Vedotin 1.25 mg/kg
regimen
Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04995419-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-tecentriq-e0f5bc9f
nct id
NCT04995419
harm key
EG000
source section id
NCT04995419-ae
event group key
EG000
event group label
Enfortumab Vedotin 1.25 mg/kg
serious affected
18
serious at risk
40
other affected
40
other at risk
40
frequency threshold
5
collection period
Baseline up to 9.33 months
event definition
SAF
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