Trial · NCT04963153
Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy
NCT04963153, Phase 1, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy. Trials, record NCT04963153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04963153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy
- NCT number
- NCT04963153
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 24 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Locally Advanced Urethral Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Recurrent Bladder Urothelial Carcinoma, Recurrent Renal Pelvis Urothelial Carcinoma, Recurrent Ureter Urothelial Carcinoma, Recurrent Urethral Urothelial Carcinoma, Recurrent Urothelial Carcinoma, Stage IIIB Bladder Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Renal Pelvis Cancer AJCC v8, Stage IV Ureter Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8
- Interventions
- Biospecimen Collection, Bone Scan, Computed Tomography, Echocardiography Test, Enfortumab Vedotin, Erdafitinib, Multigated Acquisition Scan
- First posted
- 2021-07-15
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events | Up to 2 years | |
| Primary | Recommended phase II dose | Up to 28 days | |
| Primary | Maximum tolerated dose of enfortumab vedotin | Up to 28 days | The highest dose of enfortumab vedotin in combination with fixed dose erdafitinib that does not cause unacceptable side effect. |
| Secondary | Overall response rate | Up to 2 years from study enrollment | Will be summarized using descriptive statistics including two-sided 95% confidence interval (CI) based on Clopper-Pearson method. |
| Secondary | Duration of response | Time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years from study enrollment | Will be summarized using mean, standard deviation, median, and range. |
| Secondary | Progression free survival | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | Kaplan-Meier curve estimates of medians and their corresponding 95% CIs will be calculated. |
| Secondary | Overall survival | Up to 2 years from study enrollment | Kaplan-Meier curve estimates of medians and their corresponding 95% CIs will be calculated. |
| Other | PD-L1, Nectin-4, FGFR3/phosphor-FGFR3, cell lineage and progression marker expression | Up to 2 years from study enrollment | |
| Other | Tumor subtyping, tumor microenvironment, and mutations associated with treatment response | Up to 2 years from study enrollment | Will be evaluated based on pre-treatment sequencing data. |
| Other | Mechanisms of resistance and response | Up to 2 years from study enrollment | Will be evaluated through peripheral blood circulating tumor deoxyribonucleic acid (DNA). Methods of analysis may include but not limited to, immunohistochemistry, next-generation sequencing of DNA and ribonucleic acid, and immunoassays. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186644 | North American Star Consortium | BEDARD, PHILIPPE; COURTNEY, KEVIN D; GRANT, STEVEN; LANCET, JEFFREY; MAHALINGAM, DEVALINGAM; SIU, LILLIAN L | UNIVERSITY HEALTH NETWORK | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04963153
GET https://conductscience.org/api/trials/v1/NCT04963153/registered