Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Purpose
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.
Condition
- Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
Eligibility
- Eligible Ages
- Between 1 Year and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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;
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| dabrafenib plus trametinib | patients treated with dabrafenib and trametinib |
|
Recruiting Locations
Lundquist Inst BioMed at Harbor
Torrance, California 90509-2910
Torrance, California 90509-2910
Rocky Mountain Cancer Centers
Denver, Colorado 80218
Denver, Colorado 80218
Johns Hopkins University
Washington D.C., District of Columbia 20016
Washington D.C., District of Columbia 20016
Duke Clinical Research Institute
Durham, North Carolina 27704
Durham, North Carolina 27704
Oncology Hematology Care Inc
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Texas Oncology San Antonio
San Antonio, Texas 78258
San Antonio, Texas 78258
More Details
- NCT ID
- NCT05868629
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals