Trial · NCT04504916
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR)- Blinded Independent Central Review (BICR) | Up to ~18 months | Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug | Percentage of Participants | NUMBER |
| SECONDARY | ORR- Investigator Assessed | Up to ~18 months | FAS which included all participants who received ≥1 dose of study drug | Percentage of Participants | NUMBER |
| SECONDARY | Time to Response (TTR)- BICR | Up to ~30 months | Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response. | Months | MEAN |
| SECONDARY | Duration of Response (DOR)- BICR | Up to ~30 months | Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS)- BICR | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Months | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF)- BICR | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to ~30 months | FAS which included all participants who received ≥1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to ~11 months | FAS which included all participants who received ≥1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Zilovertamab Vedotin-Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Total Antibody-Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of MMAE-Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve (AUC) 0-504hrs of Zilovertamab Vedotin- Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | hr*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-504hrs of Total Antibodies-Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | hr*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-504hrs of MMAE-Q1/3W Dosing Schedule | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | hr*μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 1 | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 1 | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of MMAE-Q2/3W Dosing Schedule: Day 1 | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8 | Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 8 | Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | μg/mL | GEOMETRIC_MEAN |
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.
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