Trial · NCT03390504

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

NCT03390504, Phase 3, Active not recruiting, Janssen Research & Development, LLC; results first posted 2025-05-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations. Trials, record NCT03390504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03390504

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations
NCT number: NCT03390504
Status: Active not recruiting
Phases: Phase 3
Enrollment: 629 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Urothelial Cancer
Interventions: Erdafitinib, Vinflunine, Docetaxel, Pembrolizumab, Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
First posted: 2018-01-04
Last updated: 2026-11-03
Other registries' IDs: eudract:2017-002932-18
Results first posted: 2025-05-14

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)	Overall survival was measured from the date of randomization to the date of the participant's death.
Secondary	Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	From randomization (3 days prior to Cycle 1 Day 1) until disease progression or relapse from CR or death (maximum up to 51.7 months)	PFS was defined as the time from the date of randomization to the date of disease progression or relapse from complete response (CR) based on investigator assessment using RECIST v 1.1, or death due to any cause, whichever occurred first. As per RECIST v 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). Progressive disease (PD) was defined as at least 20 percent (%) increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of greater than or equal to (\>=) 5 mm or appearance of at least 1 new lesion.
Secondary	Objective Response Rate (ORR) Per RECIST Version 1.1	From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months	ORR was defined as the percentage of participants who achieved CR or partial response (PR) as determined by investigator per RECIST v1.1. 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 \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Secondary	Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl)	Baseline up to Cycle 11 (each cycle was of 21 days)	The FACT-Bl consisted of 39 items, with 5-point Likert scales, covering 5 primary domains: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns for participants with bladder cancer. The response options ranged from 0 to 4 where, 0='Not at all" and 4= "very much." FACT-Bl total score ranged from 0 (worst) to 156 (best). The higher the score, the better the quality of life (QOL). The baseline value was defined as the value collected at the time closest to but prior to the randomization.
Secondary	Time Until Symptom Deterioration	Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months	Time until symptom deterioration was defined as the first time to increase in urinary bladder cancer symptoms score from the day of randomization beyond a meaningful change threshold compared to baseline. The urinary bladder cancer symptom score was subset of FACT-Bl which included 3 items related to urinary symptoms, 5-point Likert scale. Response options ranged from 0 to 4, 0 = Not at all, 1= A little bit, 2= Somewhat, 3=Quite a bit, 4 = Very much. A response of 0 indicated no symptoms and 4 indicated severe symptoms. Total sum scores ranged from 0 to 12, higher scores indicate relatively poor quality of life.
Secondary	Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS)	Baseline, 51.7 months	The PGI-S was a single item patient-reported measure assessing participants' impression of severity in bladder cancer symptoms. It uses a 4-point Likert scale as follows: symptoms are: 0-"absent (no symptoms)", 1-"mild", 2-"moderate", 3="severe" and 4= "very severe". Percentage of participants with shift from baseline in PGIS score were reported. A negative shift from baseline in PGIS score indicated Improvement and positive shift from baseline in PGIS score indicated Worsening. The baseline value was defined as the value collected at the time closest to but prior to the randomization.
Secondary	Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	Baseline up to Cycle 11 (each cycle was of 21 days)	The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L was a 5-item questionnaire that assessed 5 domains included mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Health utility values generated from the EQ-5D generally range from 0 (a state as bad as being dead) to 1 (full health), with higher scores indicating better QoL. The EQ visual analog scale (VAS) recorded the patient's self-rated health on a VAS, ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better QoL. The baseline value was defined as the value collected at the time closest to but prior to the randomization.
Secondary	Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	Baseline up to Cycle 11 (each cycle was of 21 days)	The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L was a 5-item questionnaire that assessed 5 domains included mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Health utility values generated from the EQ-5D generally range from 0 (a state as bad as being dead) to 1 (full health), with higher scores indicating better QoL. The EQ VAS recorded the patient's self-rated health on a VAS, ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better QoL. The baseline value was defined as the value collected at the time closest to but prior to the randomization.
Secondary	Duration of Response (DOR) as Per RECIST Version 1.1	From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months)	DOR was defined as time from the date of initial documentation of an overall response (CR or PR) to the date of first documented evidence of progressive disease (PD) (or relapse for participants who experience CR) or death. 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 \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From start of the treatment (Day 1 Cycle 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy (maximum up to 51.7 months)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were the events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure.

1 to 10 of 21Source ClinicalTrials.gov

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Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	From randomization (3 days prior to Cycle 1 Day 1) until death due to any cause (maximum up to 51.7 months)	Intent-to-Treat (ITT) analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized.	Months	MEDIAN
SECONDARY	Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	From randomization (3 days prior to Cycle 1 Day 1) until disease progression or relapse from CR or death (maximum up to 51.7 months)	ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR) Per RECIST Version 1.1	From start of the treatment (Day 1 Cycle 1) up to maximum of 51.7 months	ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in Physical Functioning Scales of the Functional Assessment of Cancer Therapy - Bladder Cancer (FACT-Bl)	Baseline up to Cycle 11 (each cycle was of 21 days)	Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Time Until Symptom Deterioration	Randomization (3 days prior to Cycle 1 Day 1) up to maximum of 51.7 months	Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.	Months	MEDIAN
SECONDARY	Percentage of Participants With Shift From Baseline in Patient-Global Impression of Severity (PGIS)	Baseline, 51.7 months	Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in Utility Scale of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	Baseline up to Cycle 11 (each cycle was of 21 days)	Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Visual Analog Scale (VAS) of the European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L)	Baseline up to Cycle 11 (each cycle was of 21 days)	Analysis population set included in ITT (all randomized) participants with available data for this outcome measure.	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Duration of Response (DOR) as Per RECIST Version 1.1	From date of first documented response to date of first documented PD or death whichever occurred first (maximum up to 51.7 months)	ITT analysis set included all randomized participants. Participants in this population were analyzed according to the treatment to which they were randomized. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.	Months	MEDIAN
SECONDARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From start of the treatment (Day 1 Cycle 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy (maximum up to 51.7 months)	Safety analysis set included all randomized participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 21Source ClinicalTrials.gov

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Results by group348

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	12.06	95% Confidence Interval 10.25 to 16.36	Months
Overall Survival (OS)	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	8.74	95% Confidence Interval 6.67 to 10.71	Months
Overall Survival (OS)	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	10.91	95% Confidence Interval 9.23 to 12.58	Months
Overall Survival (OS)	Cohort 2: Arm 2B: Pembrolizumab 200 mg	11.07	95% Confidence Interval 9.72 to 13.63	Months
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	5.39	95% Confidence Interval 4.37 to 5.62	Months
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	2.73	95% Confidence Interval 2.10 to 4.17	Months
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	4.44	95% Confidence Interval 4.07 to 5.49	Months
Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1	Cohort 2: Arm 2B: Pembrolizumab 200 mg	2.69	95% Confidence Interval 1.64 to 3.02	Months
Objective Response Rate (ORR) Per RECIST Version 1.1	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	46.9		Percentage of participants
Objective Response Rate (ORR) Per RECIST Version 1.1	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	12.6		Percentage of participants

1 to 10 of 348Source ClinicalTrials.gov

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Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	143
Overall Study	STARTED	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	135
Overall Study	STARTED	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	175
Overall Study	STARTED	Cohort 2: Arm 2B: Pembrolizumab 200 mg	176
Overall Study	Treated	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	142
Overall Study	Treated	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	117
Overall Study	Treated	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	173
Overall Study	Treated	Cohort 2: Arm 2B: Pembrolizumab 200 mg	173
Overall Study	COMPLETED	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	137
Overall Study	COMPLETED	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	114

1 to 10 of 16Source ClinicalTrials.gov

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Adverse events1,096

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	40	142
other	Anaemia	Blood and lymphatic system disorders	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	39	117
other	Anaemia	Blood and lymphatic system disorders	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	51	173
other	Anaemia	Blood and lymphatic system disorders	Cohort 2: Arm 2B: Pembrolizumab 200 mg	44	173
other	Leukopenia	Blood and lymphatic system disorders	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	1	142
other	Leukopenia	Blood and lymphatic system disorders	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	15	117
other	Leukopenia	Blood and lymphatic system disorders	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	5	173
other	Leukopenia	Blood and lymphatic system disorders	Cohort 2: Arm 2B: Pembrolizumab 200 mg	0	173
other	Neutropenia	Blood and lymphatic system disorders	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	0	142
other	Neutropenia	Blood and lymphatic system disorders	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	24	117

1 to 10 of 1,096Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	91	143
Total, all-cause mortality	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	90	135
Total, all-cause mortality	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	141	175
Total, all-cause mortality	Cohort 2: Arm 2B: Pembrolizumab 200 mg	131	176
Total, other adverse events	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	141	142
Total, other adverse events	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	104	117
Total, other adverse events	Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg	173	173
Total, other adverse events	Cohort 2: Arm 2B: Pembrolizumab 200 mg	157	173
Total, serious adverse events	Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg	63	142
Total, serious adverse events	Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)	50	117

1 to 10 of 12Source ClinicalTrials.gov

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Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37870920	DERIVED	PubMed
43001410	DERIVED	PubMed
43004726	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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