Trial · NCT06758401
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Baseline to date of death from any cause (Approximately 2 years). | Overall survival defined as the duration from enrollment to death. |
| Primary | Progression Free Survival (PFS) assessed by blinded independent central review (BICR) | From Baseline to to date of first documentation of progression OR death (Approximately 2 years). | Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first. |
| Secondary | Progression Free Survival as assessed by Investigator | From Baseline to date of first progression or death (Approximately 4 years). | Progression Free Survival (PFS) is defined as the time from the date of first dose of study interventions to the date of first documentation of PD or death due to any cause, whichever occurs first. |
| Secondary | Objective Response Rate as assessed by BICR | From Baseline to to the date of progression OR death (approximately to 4 years). | Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first. |
| Secondary | Objective Response Rate as assessed by Investigator | From Baseline to to the date of progression OR death (approximately to 4 years). | Defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator. |
| Secondary | Duration of Response as assessed by BICR | From the date of the first objective response to the date of disease progression or death (approximately to 4 years). | Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first. |
| Secondary | Duration of Response as assessed by Investigator | From the date of the first objective response to the date of disease progression or death (approximately to 4 years). | Defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment. |
| Secondary | Number of participants with adverse events (AEs) | From Baseline to end of treatment (up to 4 years). | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Secondary | Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Plasma concentration at end of infusion (CEOI) | Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1. | To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab. |
| Secondary | PK of ac-MMAE in plasma: Plasma predose concentration (Cpredose) | Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1. | To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab. |
| Secondary | PK of unconjugated monomethyl auristatin E (MMAE) in plasma: Plasma concentration at end of infusion (CEOI) | Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1. | To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab. |
| Secondary | PK of MMAE in plasma: Plasma predose concentration (Cpredose) | Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1. | To characterize the pharmacokinetics (PK) of sigvotatug vedotin when administered in combination with pembrolizumab. |
| Secondary | Number of participants with antidrug antibodies (ADAs) | Cycle 1 (up to Day 29), Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 29, Cycle 8 Day 15, Cycle 11 Day 1, Cycle 14 Day 1, and Cycle 18 Day 1. | To characterize the immunogenicity of sigvotatug vedotin when administered in combination with pembrolizumab. |
| Secondary | Time to response (TTR) using RECIST v1.1 as assessed by BICR | The time from the date of randomization to the date of first documentation of objective response. | Defined as the time from the date of randomization to the date of first documentation of objective response (CR or PR that is subsequently confirmed) per RECIST v1.1 by BICR. |
| Secondary | TTR using RECIST v1.1 as assessed by investigator | The time from the date of randomization to the date of first documentation of objective response. | Defined as the time from the date of randomization to the date of first documentation of objective response (CR or PR that is subsequently confirmed) per RECIST v1.1 by investigator assessment. |
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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