Trial · NCT05756569
Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
NCT05756569, Phase 2, Recruiting, Emory University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology. Trials, record NCT05756569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05756569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
- NCT number
- NCT05756569
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Emory University
- Conditions
Bladder Squamous Cell Carcinoma, Locally Advanced Bladder Carcinoma, Malignant Renal Pelvis Neoplasm, Malignant Ureter Neoplasm, Malignant Urethral Neoplasm, Metastatic Bladder Carcinoma, Stage III Bladder Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Unresectable Bladder Carcinoma, Urachal Adenocarcinoma, Bladder Adenocarcinoma
- Interventions
- Biospecimen Collection, Computed Tomography, Enfortumab Vedotin, Magnetic Resonance Imaging, Pembrolizumab, Questionnaire Administration
- First posted
- 2023-03-06
- Last updated
- 2026-07-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate | Up to 2 years | Will be measured by Response Evaluation Criteria in Solid Tumors version 1.1, and estimated by the Clopper-Pearson method with 95% confidence intervals. |
| Secondary | Progression free survival | From treatment initiation until disease progression or death due to any cause, assessed up to 2 years | Kalan-Meier method will be used to estimate median event time and 2-year survival rate with 95% confidence interval. |
| Secondary | Overall survival | From treatment initiation until death due to any cause, assessed up to 2 years | Kalan-Meier method will be used to estimate median event time and 2-year survival rate with 95% confidence interval. |
| Secondary | Duration of response | From response initiation to progression or death, whichever occurs first, assessed up to 2 years | Determined by occurrence of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. |
| Secondary | Incidence of adverse events | Assessed up to 2 years | Graded according to the Common Terminology Criteria for Adverse Events version 5.0, and will be tabulated using descriptive statistics (mean, median, minimum, maximum, standard deviation). |
Source ClinicalTrials.gov
Outcomes0
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 |
|---|---|---|---|---|---|
| P30CA138292 | Winship Cancer Institute Cancer Center Support Grant | RAMALINGAM, SURESH S | EMORY UNIVERSITY | NATIONAL CANCER INSTITUTE | 2009 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/NCT05756569
GET https://conductscience.org/api/trials/v1/NCT05756569/registered