Trial · NCT06764875
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 | Progression free survival (PFS) | Up to approximately 6 years | PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. |
| Primary | Overall Survival (OS) | Up to approximately 6 years | OS is defined as time from randomization until the date of death due to any cause. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 6 years | ORR according to RECIST v1.1. ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR). |
| Secondary | Duration of Response (DoR) | Up to approximately 6 years | DoR according to RECIST v1.1. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 or death due to any cause. |
| Secondary | Proportion of all randomized participants alive and progression-free at 6 months (PFS6) | Up to 6 months | Proportion of all randomized participants alive and progression-free at 6 months calculated for progression. |
| Secondary | Proportion of all randomized participants alive and progression-free at 12 months (PFS12) | Up to 12 months | Proportion of all randomized participants alive and progression-free at 12 months calculated for progression. |
| Secondary | Time to second progression or death (PFS2) | Up to approximately 6 years | PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial progression), after the first subsequent therapy, or death, where the first objective progression includes progression occurring after 2 missed visits. |
| Secondary | Occurrence of adverse events (AEs) and serious adverse events (SAEs) | Up to approximately 6 years | Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0. |
| Secondary | Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum | Up to approximately 6 years | Concentration of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, fluoropyrimidine, and capecitabine in serum or plasma. |
| Secondary | Immunogenicity of rilvegostomig and T-DXd assessed by the presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd | Up to approximately 6 years | Presence of antidrug antibodies (ADAs) for rilvegostomig and T-DXd (confirmatory results: titers and neutralizing antibodies for confirmed positive samples). |
| Secondary | Increase in enteral feeding assistance and eating difficulties | Up to approximately 6 years | Time to first-confirmed worsening of eating symptoms or initiation of feeding assistance among all participants, as randomized. |
| Secondary | Proportion of time on study intervention with high side-effect bother | Up to approximately 6 years | Proportion of time on study intervention with high side-effect bother relative to low side-effect burden as measured by the Patient Global Impression of Treatment Tolerability (PGI-TT). |
| Secondary | Overall Survival at 12 months (OS12) | Up to 12 months | Proportion of all randomized participants alive at 12 months. |
| Secondary | Overall Survival at 24 months (OS24) | Up to 24 months | Proportion of all randomized participants alive at 24 months. |
| Secondary | Pharmacokinetics (PK) of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd, 5-FU, and capecitabine in serum | Up to approximately 6 years | PK parameters (peak and trough concentrations). |
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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