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
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