Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

NCT ID: NCT05984615

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1961 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2022-08-24

Brief Summary

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This was a retrospective real-world evidence cohort study.

Detailed Description

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Conditions

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BRAF Positive Metastatic Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Immunotherapy (IO) Cohort

No interventions assigned to this group

Targeted Therapy (TT) Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of melanoma (The International Classification of Diseases, 9th Revision \[ICD-9\] 172.x \& 10th revision \[ICD-10\] C43 or D03x).
* Pathologic stage IV at initial diagnosis on or after 01 January 2011.
* First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014.
* Evidence of a BRAF test.
* Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation.
* At least 18 years of age at the time of initiation of 1L treatment.

Exclusion Criteria

* Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014.
* Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CTMT212AUS63

Identifier Type: -

Identifier Source: org_study_id

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