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
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
- Age range
- 1–100 years
- Sex
- All
- 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, A…
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 HarborTorrance, California
- Rocky Mountain Cancer CentersDenver, Colorado
- Johns Hopkins UniversityWashington D.C., District of Columbia
- Duke Clinical Research InstituteDurham, North Carolina
- Oncology Hematology Care IncCincinnati, Ohio
- Sarah Cannon Research InstituteNashville, Tennessee