Trial · NCT03258593
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Grades 1-5 Adverse Events | Through study completion, an average of 315 days | adverse events | NUMBER | |
| SECONDARY | Urinary Epithelial Cell Adhesion Molecule (EpCAM) Compared Between Participants Who Have a Clinical Response to Therapy vs. Those Who do Not Respond | Baseline, week 1, weeks 2-5, week 6, week 10 and week 12 | |||
| SECONDARY | Response Rate | From enrollment until event occurrence (recurrence, progression); twelve weeks. | percentage of participants | NUMBER | |
| SECONDARY | Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum | Baseline, week 1, week 6, week 12 | ng/mL | MEDIAN | |
| SECONDARY | Change in Programmed Death-ligand 1 (PD-L1) Levels Between Responders and Non-Responders | Baseline and after treatment with both agents, from enrollment up to 5 weeks | Number of responders and non-responders in the rows below = overall number of participants analyzed for each group. | pg/mL | MEDIAN |
| SECONDARY | Change in Programmed Cell Death Protein 1 (PD-1) Levels Between Responders and Non-Responders | baseline and after treatment with both agents | |||
| SECONDARY | Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) | Baseline and after treatment, from enrollment up to 5 weeks | Number of participants with SD and participants with PD in the rows below = overall number of participants analyzed for each group. | pg/mL | MEDIAN |
| SECONDARY | Change in Programmed Cell Death Protein 1(PD-1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD) | baseline and after treatment | |||
| SECONDARY | Changes in the Immune Parameters Obtained From Blood Samples | baseline, 3 weeks, and 5 weeks | pg/mL | MEDIAN | |
| SECONDARY | Changes in the Immune Parameters Obtained From Biopsies | baseline, 3 months, and 6 months | |||
| SECONDARY | Disease Free Survival (DFS) | Assessed from start of therapy to disease recurrence or last follow up; up to 1 year. | Weeks | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Through study completion, an average of 315 days. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Maximum Tolerated Dose (MTD) of Durvalumab | 6 weeks | Mg | NUMBER | |
| OTHER_PRE_SPECIFIED | Maximum Tolerated Dose (MTD) of Vicineum | 6 weeks | Mg | NUMBER | |
| OTHER_PRE_SPECIFIED | Dose-Limiting Toxicity (DLT) | 6 weeks | percentage of participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03258593/outcomes