MelanomaOCEANMISTNCT05260684

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

An observational study of Melanoma, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy. The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma
What is being tested?: Encorafenib, Binimetinib and Vemurafenib
Type of treatment: Pill or oral medicine
How many people: 716 participants
Where: 1 siteUnited States
Study dates: 17 Jan 2022to 31 Dec 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population will be metastatic melanoma patients receiving targeted combination therapies derived from an anonymized Flatiron Health data combined with patient data from COLUMBUS trial data

Who may be able to join

Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011.
Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011.
Age ≥18 years at the time of advanced melanoma diagnosis.
Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results.

Who cannot join

-• Patients with prior BRAF- or MEK-inhibitor therapy
Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
New York, New York, 10017

Other trials in United States

About this study

Official title: Comparative Effectiveness of Different Targeted Therapies for BRAF-mutated Unresectable/Metastatic Melanoma in the United States

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy.

The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.

Conditions: Melanoma
Being tested: Encorafenib, Binimetinib, Vemurafenib, Cobimetinib, Dabrafenib
Keywords: BRAF-mutant, Metastatic melanoma
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EncorafenibDrug
Also called Administration route: Oral
450 mg QD
BinimetinibDrug
Also called Administration route: Oral
45 mg BID
VemurafenibDrug
Also called Administration route: Oral
960 mg BID for 28 days/cycle
CobimetinibDrug
Also called Administration route: Oral
60 mg QD for 21 days/cycle
DabrafenibDrug
Also called Administration route: Oral
150 mg BID
TrametinibDrug
Also called Administration route: Oral
2 mg QD

Study groups in NCT05260684
Study group	Role	What they receive
Encorafenib + binimetinib		Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID) Receives: Drug: Encorafenib; Drug: Binimetinib
Vemurafenib + Cobimetinib		Vemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle Receives: Drug: Vemurafenib; Drug: Cobimetinib
Dabrafenib + trametinib		Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD) Receives: Drug: Dabrafenib; Drug: Trametinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
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. Index date in each treatment group was defined as the date of treatment initiation. Kaplan-Meier analyses was used for analysis.
Measured: 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 (92.7 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 202231 Dec 2023

First posted2 Mar 2022
Study start17 Jan 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 716 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05260684
Sponsor's protocol ID: C4221028
Other IDs: OCEANMIST
Acronym: OCEANMIST
Status last verified: Mar 2025
First submitted: 11 Jan 2022
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
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Active, not recruitingPhase 1/2
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All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Different Targeted Therapies for BRAF-mutated Unresectable/Metastatic Melanoma in the United States
ClinicalTrials.gov ID: NCT05260684
Acronym / sponsor ID: OCEANMIST / C4221028
Conditions: Melanoma
Keywords: BRAF-mutant, Metastatic melanoma
Study type: Observational
Recruitment status: Completed
Enrolment: 716 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Jan 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 2 Mar 2022 (actual)
Results: Posted 6 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy.

The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Encorafenib + binimetinib	–	Drug: Encorafenib, Drug: BinimetinibEncorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
Vemurafenib + Cobimetinib	–	Drug: Vemurafenib, Drug: CobimetinibVemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle
Dabrafenib + trametinib	–	Drug: Dabrafenib, Drug: TrametinibDabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will be metastatic melanoma patients receiving targeted combination therapies derived from an anonymized Flatiron Health data combined with patient data from COLUMBUS trial data

Key inclusion criteria (4 listed)

Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011.
Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011.
Age ≥18 years at the time of advanced melanoma diagnosis.
Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results.

Key exclusion criteria (2 listed)

-• Patients with prior BRAF- or MEK-inhibitor therapy
Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EncorafenibAlso: Administration route: Oral450 mg QD	Drug	Encorafenib + binimetinib
BinimetinibAlso: Administration route: Oral45 mg BID	Drug	Encorafenib + binimetinib
VemurafenibAlso: Administration route: Oral960 mg BID for 28 days/cycle	Drug	Vemurafenib + Cobimetinib
CobimetinibAlso: Administration route: Oral60 mg QD for 21 days/cycle	Drug	Vemurafenib + Cobimetinib
DabrafenibAlso: Administration route: Oral150 mg BID	Drug	Dabrafenib + trametinib
TrametinibAlso: Administration route: Oral2 mg QD	Drug	Dabrafenib + trametinib

Primary outcome

Overall Survival (OS)
Time frame: 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 (92.7 months)
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. Index date in each treatment group was defined as the date of treatment initiation. Kaplan-Meier analyses was used for analysis.

Results and safety

Results posted to the registry on 6 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Encorafenib+Binimetinib	275	275
Dabrafenib+Trametinib	387	387
Vemurafenib + Cobimetinib	54	54

Primary outcome: Overall Survival (OS)

Time frame: 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 (92.7 months). Median (95% Confidence Interval). Unit: Months

Measure	Dabrafenib+Trametinib n = 387	Vemurafenib + Cobimetinib n = 54	Encorafenib+Binimetinib n = 275
Value	16.1 (13.7 to 18.7)	25.0 (17.0 to NA)	30.0 (24.4 to 37.6)

Dabrafenib+Trametinib vs Encorafenib+Binimetinib: Hazard Ratio (HR): 1.32 (95% CI 1.05 to 1.65), p = 0.02, Wald Chi- Square Statistic
Vemurafenib + Cobimetinib vs Encorafenib+Binimetinib: Hazard Ratio (HR): 1.17 (95% CI 0.76 to 1.79), p = 0.47, Wald Chi- Square Statistic

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Adverse events

Time frame: All-cause mortality: COLUMBUS trial from 30-December-2013 to 15-September-2020 [approximately 80.5 months] and Flatiron EHR RWD from duration of 09-January-2014 to 30-September-2021 [92.7 months]; For adverse events it was not applicable as adverse event data was not planned to be collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Encorafenib+Binimetinib	0 of 0	0 of 0	159 of 275
Dabrafenib+Trametinib	0 of 0	0 of 0	259 of 387
Vemurafenib + Cobimetinib	0 of 0	0 of 0	30 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Melanoma, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 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 (92.7 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05260684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.