Trial · NCT06535607
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | Through study completion, an average of 4 years | Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by Investigator per RECIST 1.1. |
| Primary | The number of participants with adverse events/serious adverse events | Through study completion, an average of 4 years | Number of participants 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. |
| Secondary | Duration Of Response (DOR) | Through study completion, an average of 4 years | DoR is defined as the time from the date of first documented confirmed response (which is subsequently confirmed) until date of documented progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause. |
| Secondary | Progression free survival (PFS) | Through study completion, an average of 4 years | PFS is defined as the time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by Investigator or ICR, or death due to any cause. |
| Secondary | Time to response (TTR) | Through study completion, an average of 4 years | TTR is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1, as assessed by Investigator or ICR. |
| Secondary | Overall Survival (OS) | Through study completion, an average of 4 years | OS is defined as the time from the date of first dose of study intervention until the date of death due to any cause. |
| Secondary | PK of volrustomig | Through study completion, an average of 4 years | Concentration of Volrustomig in serum. |
| Secondary | The immunogenicity of volrustomig | Through study completion, an average of 4 years | Incidence of ADAs against volrustomig in serum. |
| Secondary | Disease control rate (DCR) | Through study completion, an average of 4 years | Disease control rate is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or SD, as determined by Investigator per RECIST 1.1. |
| Secondary | PFS landmark | Through study completion, an average of 4 years | The landmark of PFS rates at 6, 9, and 12 months. |
| Secondary | OS landmark | Through study completion, an average of 4 years | The median OS and the landmark of OS rate at 12 months. |
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/NCT06535607/registered