Trial · NCT06989112
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS), as assessed by BICR | Until progression or death due to any cause (assessed up to approximately 45 months). | Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause. |
| Secondary | Overall Survival (OS) | Until the date of death due to any cause (assessed up to approximately 70 months). | Defined as the time from randomization until the date of death due to any cause. |
| Secondary | Progression Free Survival (PFS) as assessed by the investigator | Until progression or death due to any cause (assessed up to approximately 70 months). | PFS by investigator has the same attributes as estimand of PFS by BICR except tumor assessment is by the investigator. |
| Secondary | Time from randomization to second progression or death (PFS2) | Until the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death (assessed up to approximately 70 months). | PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death. |
| Secondary | Objective response rate (ORR), as assessed by BICR and investigator | Until progression or the starting of subsequent anticancer therapy (assessed up to approximately 45 months). | ORR as assessed and confirmed by BICR is defined as the proportion of participants who have a complete response (CR) or partial response (PR), as determined and confirmed by BICR. ORR as assessed and confirmed by the investigator has the same attributes as estimand of ORR by BICR except tumor assessment per the investigator. |
| Secondary | Duration of response (DoR), as assessed by BICR and investigator | Until progression or death due to any cause (assessed up to approximately 45 months). | DoR as assessed by BICR will be defined as the time from the date of first documented response of confirmed responders until date of documented progression per RECIST 1.1, or death due to any cause. DoR as assessed by the investigator has the same attributes as estimand of DoR by BICR except tumor assessment per the investigator. |
| Secondary | Safety and tolerability | Safety is assessed until the 90 days (+7) after the last dose (assessed up to approximately 70 months). | Safety and tolerability will be evaluated in terms of AEs/serious AEs (SAEs), AESI, vital signs, clinical safety laboratory assessments, ECG and ECHO/MUGA scan results. |
| Secondary | Pharmacokinetics of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig | Up to safety follow-up period (assessed up to approximately 45 months). | Serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig. |
| Secondary | Immunogenicity of T- DXd and rilvegostomig | Up to safety follow-up period (assessed up to approximately 45 months). | Presence of ADAs for T-DXd or rilvegostomig. |
| Secondary | Patient-reported tolerability | Until progression as assessed by BICR (assessed up to approximately 45 months). | Patient-reported tolerability will be described among participants, as treated, using the following outcomes: * Symptomatic AEs: Descriptive summary of the proportion of participants reporting symptomatic AEs while on treatment, as assessed by items from the EORTC Item Library and the FACT/GOG-NTX-4 * Overall side-effect bother: Descriptive summary of the proportion of participants reporting overall side-effect bother on the PGI-TT while on treatment |
| Secondary | Progression-free survival (PFS) according to MMR status to determine the clinical utility of a MMR diagnostic test | Through completion of study, assessed up to approximately 70 months. | PFS is defined as time from randomization until progression per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause. |
| Secondary | Overall survival (OS) according to MMR status to determine the clinical utility of a MMR diagnostic test | Through completion of study, assessed up to approximately 70 months. | OS defined as the time from randomization until the date of death due to any cause. |
| Secondary | Progression-free survival (PFS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test | Through completion of study, assessed up to approximately 70 months. | PFS is defined as time from randomization until progression per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause. |
| Secondary | Overall survival (OS) according to HER2 expression to determine the clinical utility of a HER2 diagnostic test | Through completion of study, assessed up to approximately 70 months. | OS is defined as the time from randomization until the date of death due to any cause. |
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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