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NCT05868629Recruiting

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

Novartis Pharmaceuticals

Start Date

2/6/2024

Completion Date

3/3/2028

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 Criteria

Age Range: 1 years to 100 years

Inclusion Criteria: * Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test; * At least 1 measurable lesion as defined by RECIST v1.1 per local review; * Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year; * Ability to provide scans for central imaging review Exclusion Criteria: * Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC; * Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;

Interventions

OTHER

Non-investigational

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Conditions

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

Locations

Lundquist Inst BioMed at Harbor

Torrance, California 90509-2910

United States

Rocky Mountain Cancer Centers

Denver, Colorado 80218

United States

Johns Hopkins University

Washington D.C., District of Columbia 20016

United States

Duke Clinical Research Institute

Durham, North Carolina 27704

United States

Oncology Hematology Care Inc

Cincinnati, Ohio 45242

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

El Paso Texas Oncology

El Paso, Texas 79902

United States

Texas Oncology San Antonio

San Antonio, Texas 78258

United States