RecruitingNCT05868629

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors


Sponsor

Novartis Pharmaceuticals

Enrollment

40 participants

Start Date

Feb 6, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.


Eligibility

Min Age: 1 YearMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted cancer drugs — dabrafenib and trametinib — in people with rare solid tumours that carry a specific genetic change called the BRAF V600E mutation. This mutation acts like a stuck accelerator in cancer cells, and these drugs are designed to switch it off. **You may be eligible if...** - You have a solid tumour confirmed to carry the BRAF V600E mutation (by a lab test) - You have at least one measurable tumour - You have not previously been treated with dabrafenib or trametinib (or stopped treatment more than 1 year ago) **You may NOT be eligible if...** - Your tumour does not carry the BRAF V600E mutation - You have previously received and recently discontinued dabrafenib or trametinib - You have certain serious medical conditions affecting your heart, liver, or eyes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-investigational

Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program


Locations(8)

Lundquist Inst BioMed at Harbor

Torrance, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Johns Hopkins University

Washington D.C., District of Columbia, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

Oncology Hematology Care Inc

Cincinnati, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

El Paso Texas Oncology

El Paso, Texas, United States

Texas Oncology San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05868629