An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial 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

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

primary · POSTED

Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR.

The population included participants who received at least 1 dose of study drug.

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primary · POSTED

Cmax is the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.

Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

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primary · POSTED

Cmax is the maximum observed plasma concentration of 1-OH-Midazolam (midazolam metabolite) alone or in combination with erdafitinib.

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primary · POSTED

Cmax is the maximum observed plasma concentration of metformin alone or in combination with erdafitinib

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primary · POSTED

Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.

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primary · POSTED

Tmax is the time to reach the maximum observed plasma concentration of 1-OH-Midazolam alone or in combination with erdafitinib.

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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-opdivo-432072c9
nct id: NCT02365597
trial label: An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial 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: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0000
source section id
NCT02365597-om-0000
source outcome index
0
endpoint
Main Study: Percentage of Participants With Best (Overall) Objective Response
endpoint definition
Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR.
time origin
From Cycle 1 Day 1 up to 6 years 2 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The population included participants who received at least 1 dose of study drug.
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-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0001
source section id
NCT02365597-om-0001
source outcome index
1
endpoint
Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib
endpoint definition
Cmax is the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.
time origin
Cycle 1 Day -2 (predose) up to Day 13 post dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were 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-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0002
source section id
NCT02365597-om-0002
source outcome index
2
endpoint
Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
endpoint definition
Cmax is the maximum observed plasma concentration of 1-OH-Midazolam (midazolam metabolite) alone or in combination with erdafitinib.
time origin
Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were 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-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0003
source section id
NCT02365597-om-0003
source outcome index
3
endpoint
Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib
endpoint definition
Cmax is the maximum observed plasma concentration of metformin alone or in combination with erdafitinib
time origin
Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were 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-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0004
source section id
NCT02365597-om-0004
source outcome index
4
endpoint
Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib
endpoint definition
Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.
time origin
Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were 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-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0005
source section id
NCT02365597-om-0005
source outcome index
5
endpoint
Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
endpoint definition
Tmax is the time to reach the maximum observed plasma concentration of 1-OH-Midazolam alone or in combination with erdafitinib.
time origin
Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
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-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0000
arm key
OG000
arm label
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
regimen
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0000
arm key
OG001
arm label
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
regimen
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0000
arm key
OG002
arm label
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
regimen
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
analyzed count
101
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0001
arm key
OG000
arm label
DDI Study: Midazolam 2.5 mg Alone
regimen
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0001
arm key
OG001
arm label
DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg
regimen
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0002
arm key
OG000
arm label
DDI Study: 1-OH-Midazolam 2.5 mg Alone
regimen
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0002
arm key
OG001
arm label
DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg
regimen
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0003
arm key
OG000
arm label
DDI Study: Metformin 1000 mg Alone
regimen
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 (each cycle length=28 days).
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0003
arm key
OG001
arm label
DDI Study: Metformin 1000 mg + Erdafitinib 8 mg
regimen
Participants received single dose of metformin 1000 mg tablet, orally, once daily, starting from Day -1 through Day 14 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0004
arm key
OG000
arm label
DDI Study: Midazolam 2.5 mg Alone
regimen
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0004
arm key
OG001
arm label
DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg
regimen
Participants received single dose of pretreatment midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
outcome key
om-0005
arm key
OG000
arm label
DDI Study: 1-OH-Midazolam 2.5 mg Alone
regimen
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02365597-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-opdivo-432072c9
nct id
NCT02365597
harm key
EG000
source section id
NCT02365597-ae
event group key
EG000
event group label
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
serious affected
14
serious at risk
33
other affected
32
other at risk
33
frequency threshold
5
collection period
Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months
event definition
The population included participants who received at least 1 dose of study drug.
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-opdivo-432072c9
nct id
NCT02365597
harm key
EG001
source section id
NCT02365597-ae
event group key
EG001
event group label
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
serious affected
39
serious at risk
78
other affected
78
other at risk
78
frequency threshold
5
collection period
Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months
event definition
The population included participants who received at least 1 dose of study drug.
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-opdivo-432072c9
nct id
NCT02365597
harm key
EG002
source section id
NCT02365597-ae
event group key
EG002
event group label
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
serious affected
47
serious at risk
101
other affected
101
other at risk
101
frequency threshold
5
collection period
Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months
event definition
The population included participants who received at least 1 dose of study drug.
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-opdivo-432072c9
nct id
NCT02365597
harm key
EG003
source section id
NCT02365597-ae
event group key
EG003
event group label
Drug-Drug Interaction (DDI) Sub-study: Midazolam 2.5 mg + Metformin 1000 mg + Erdafitinib 8/9 mg
serious affected
9
serious at risk
25
other affected
25
other at risk
25
frequency threshold
5
collection period
Main study: From Day 1 up to 6 years 2 months; DDI study: From Day 1 up to 1 year 6 months
event definition
The population included participants who received at least 1 dose of study drug.
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