Trial · NCT04963153
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Other | Pharmacokinetics (PK) | Up to 2 years from study enrollment | PK analysis will be performed to explore the relationship between drug exposure, toxicity and response. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04963153/registered