Clinical trial NCT05954546: A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings
Official title: Overall Survival (OS) in Patients With Metastatic BRAFV600-mutant Melanoma Treated With Encorafenib Plus Binimetinib in the COLUMBUS Trial Versus in Real-world Practice Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Melanoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with BRAF mutant + metastatic melanoma receiving encorafenib and binimetinib

Brief 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.


Eligibility criteria: Inclusion criteria:

* Diagnosis of melanoma (International Classification of Diseases 9th or 10th Revision Clinical Modification - ICD-9-CM: 172.X; ICD-10-CM: C43.x) and secondary malignancy or metastasis (ICD-9-CM: 196.x, 197.x, 198.x; ICD-10-CM: C77.x, C78.x, C79.x).
* Confirmed BRAF V600E/V600K activating mutation reported in the data based on laboratory or genetic analysis results.
* At least 1 order or administration of ENCO+BINI treatment

Exclusion criteria:

* Patients without information on mortality
* Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron Electronic Health Record)
* Patients with a history of or concurrent uveal or mucosal melanoma, basal cell or squamous cell carcinoma (as per trial inclusion criteria); this exclusion will also be applied to RWD patients

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (approx 42.2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: