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NCT05954546 · ClinicalTrials.gov registry record
A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 275
- Enrollment target
NCT05954546: Completed study, sponsored by Pfizer.
NCT05954546 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 275 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05954546 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 275 participants
- Enrollment target
Study Summary
Brief summary The purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings. And produce results to show that combining data on encorafenib plus binimetinib from both the real-world and clinical trial settings is possible for future research studies. This study group is identified from the database who: * Have taken at least 1 order or administration of encorafenib plus binimetinib treatment after the confirmation of having metastatic melanoma after 27 June 2018. * Are at least 18 years of age at the time of first encorafenib plus binimetinib initiation (index date). * Had never received encorafenib plus binimetinib or had received first-line immunotherapy at the start of the study. * Have ECOG status of 0 or 1 at the index date. * have available data on the number of deaths in an area or group of people. Patients will be followed from the date that the patient started the first encorafenib plus binimetinib treatment (treatment initiation) up to their last date of data availability. Last date of data availability could be the date of following events: patient lost to follow up at the clinic, death, or end of the database (January 2020). The database timeframe is June 2018 to January 2020.
Primary Outcome
As per COLUMBUS trial, OS was defined as the time from the date of randomization to the date of death due to any cause; if death was not observed, participants were censored at the date of last contact or the data analysis cut-off date, whichever occurred first. As per Flatiron EHR, OS was defined as the time from the index date to the date of death; participants without a date of death were censored at their last known activity date or the end of the follow-up period, whichever occurred first.
Interventions
- DRUG Enco+bini
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2023-07-21 |
| Est. Completion | 2023-12-31 |
What the finished NCT05954546 record still lists
NCT05954546 is an observational study that tracks outcomes without assigning an intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Enco+bini is the first listed.
NCT05954546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05954546 about?
NCT05954546 is a clinical study titled "A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings". Brief summary The purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings. And produce results to show that combining data on encorafenib plus binimetinib from both the real-world and clinical trial settings is possible for fut...
What is the current status of trial NCT05954546?
This trial is currently completed. The enrollment target is 275 participants. The study started on 2023-07-21. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT05954546?
The interventions under investigation include: Enco+bini (DRUG).
Who is sponsoring clinical trial NCT05954546?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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