Trial · NCT06449209
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 | Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-related serious adverse events (SAEs) and treatment-related treatment emergent SAEs | up to 100 days after the last dose of treatment | In the combination treatment regimen according to the (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). By treatment arm and overall. |
| Primary | Occurrence of dose interruption, reduction, and discontinuation of study treatment due to TEAEs | up to 100 days after the last dose of treatment | By treatment arm and overall. |
| Primary | Objective Response Rate | until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment | Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] based on the investigator's assessment) is observed as best overall response. By treatment arm. |
| Primary | Best percentage change from baseline in the tumor size | Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment | Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the change from baseline in percent to the minimal tumor size until tumor progression/recurrence or death (whichever comes first). By treatment arm. |
| Primary | Proportion of participants who have achieved early tumor shrinkage | up to 2 months after first dose of treatment | Defined as ≥10% decrease in the pretreatment sum of diameters at first post-treatment tumor scan in target lesions. By treatment arm. |
| Secondary | PK assessment: Maximum concentration (Cmax) derived from serum concentration of investigational medicinal product (IMP) | from pre-dose to 21 days after study treatment | By treatment arm. Only for the first cycle. |
| Secondary | PK assessment: Area under the curve during the dosing interval (AUCtau) values derived from serum concentration of IMP | from pre-dose to 21 days after study treatment | By treatment arm. Only for the first cycle. |
| Secondary | Incidence of detectable BNT327 antidrug antibodies in serum | from pre-dose to 100 days after last dose of study treatment | By treatment arm and overall. |
| Secondary | Duration of Response | up to 24 months after completion of study treatment of the last participant | Defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression or death from any cause, whichever occurs first based on investigator's review. |
| Secondary | Disease Control Rate | up to 24 months after completion of study treatment of the last participant | Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST 1.1, stable disease assessed at least 6 weeks after first dose) is observed as best overall response based on the investigator's review. |
| Secondary | Time to Response | up to 24 months after completion of study treatment of the last participant | Defined as the time from randomization to first objective response (CR or PR per RECIST 1.1) based on the investigator's review. |
| Secondary | Progression-Free Survival (PFS) | up to 24 months after completion of study treatment of the last participant | Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the time from randomization to first confirmed objective tumor progression (progressive disease per RECIST 1.1), or death from any cause, whichever occurs first. |
| Secondary | PFS rate | up to 24 months after completion of study treatment of the last participant | As measured at 6, 12, 18, and 24 months |
| Secondary | Overall Survival (OS) | up to 24 months after completion of study treatment of the last participant | Defined as the time from randomization to death from any cause |
| Secondary | OS rate | up to 24 months after completion of study treatment of the last participant | As measured at 6, 12, 18, and 24 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
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GET https://conductscience.org/api/trials/v1/NCT06449209/registered