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.
Study Type
OBSERVATIONAL
Enrollment
40
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
Lundquist Inst BioMed at Harbor
Torrance, California, United States
RECRUITINGJohns Hopkins University
Washington D.C., District of Columbia, United States
RECRUITINGDuke Clinical Research Institute
Durham, North Carolina, United States
RECRUITINGOncology Hematology Care Inc
Cincinnati, Ohio, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITINGEl Paso Texas Oncology
El Paso, Texas, United States
RECRUITINGTexas Oncology San Antonio
San Antonio, Texas, United States
RECRUITINGOverall Response Rate (ORR)
Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria.
Time frame: Approximately 4 years
Duration of response (DOR)
Defined as time from the onset of tumor response until the date of the first documented progressive disease (PD) or death due to any cause.
Time frame: Approximately 4 years
Clinical benefit rate (CBR)
Defined as the proportion of study participants with a best overall response of CR, PR or stable disease (SD), lasting as per independent central review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST v1.1. or other relevant response criteria.
Time frame: Approximately 4 years
Novartis Pharmaceuticals
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