Trial · NCT05489211
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | From baseline to progressive disease or death (approximately 1 year) | Proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1. |
| Primary | The number of subjects with adverse events/serious adverse events | Throughout the treatment and the safety follow-up period 28 [+ 7] days after the discontinuation of all study interventions, except durvalumab, nivolumab, and bevacizumab for which it will be 90 [+ 7] days (approximately 1 year) | Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline. |
| Primary | PSA50 response (Substudy 3 only) | From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year) | Proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later. |
| Primary | Progression free survival (PFS) response (Substudy 4C only) | From baseline to progressive disease or death (approximately 1 year) | PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause. |
| Secondary | Progression free survival (PFS) | From baseline to progressive disease or death (approximately 1 year) | PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause. |
| Secondary | Duration Of Response (DoR) | From baseline to progressive disease or death (approximately 1 year) | DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by the investigator or death due to any cause. |
| Secondary | Disease Control Rate (DCR) | At approximately 1 year | DCR at 12 and 24 weeks is defined as the percentage of participants who prior to Progression of Disease (PD) and starting anticancer therapy have either at least one visit response of Complete response (CR)/Partial response (PR) or Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data. |
| Secondary | Best percentage change in tumour size | From baseline to progressive disease or death (approximately 1 year) | The best percentage change from baseline in tumour size will be derived as the maximum reduction from baseline or (in the absence of reduction) the minimum increase from baseline. |
| Secondary | Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Maximum plasma concentration of the drug (Cmax) | At predefined intervals throughout the treatment period (approximately 1 year) | The concentration in plasma will be determined. |
| Secondary | Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): The time taken to reach the maximum concentration (Tmax) | At predefined intervals throughout the treatment period (approximately 1 year) | The concentration in plasma will be determined. |
| Secondary | Pharmacokinetic Parameter of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Area under the plasma concentration- time curve (AUC) | At predefined intervals throughout the treatment period (approximately 1 year) | The concentration in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
| Secondary | Plasma concentration of Total anti-TROP2 antibody | Throughout the treatment period at pre-defined intervals (approximately 1 year) | Expression of TROP2 will be measured in blood sample |
| Secondary | Plasma concentration of MAAA-1181a | Throughout the treatment period at pre-defined intervals (approximately 1 year) | The concentration in plasma will be determined (Cmax will be derived). |
| Secondary | Anti Drug Antibody (ADA) for Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6) | Throughout the treatment period at pre-defined intervals and including the safety follow-up period (approximately 1 year) | Whole blood samples for determination of ADA in plasma will be collected; Percentage of patients who develop ADA |
| Secondary | Radiographic PFS (Substudy 3) | From baseline to radiographic progression or death (approximately 1 year) | PFS is defined as time from start of treatment until radiographic progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as assessed by the investigator or death due to any cause. |
| Secondary | PSA progression (Substudy 3) | From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year) | PSA progression is defined as an increase in PSA (after Week 12) of ≥25% greater than the nadir and an absolute increase of at least 2 ng/mL above nadir. |
| Secondary | CA-125 response (Substudy 4) | From baseline to CA-125 response evaluated according to the GCIG criteria (approximately 1 year) | Proportion of participants achieving a \> 50% reduction in CA-125 levels from a pre-treatment sample confirmed and maintained for at least 28 days. |
| Secondary | Overall survival (OS) (Substudy 4) | From baseline to death (approximately 1 year) | OS is defined as time from start of treatment until 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05489211/registered