Follows patients with rare BRAF V600E solid tumors taking dabrafenib and trametinib
Observes people with rare BRAF V600E solid tumors already prescribed dabrafenib and trametinib.
Plain-language title generated from the registry record
Registry title: Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Key facts
- Where
- Cincinnati, Denver, Durham, El Paso, Nashville, San Antonio, Torrance, and Washington D.C., United StatesSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 100 years old?
Source: NCT05868629, who can take part
Where in United States
- Oncology Hematology Care, IncCincinnati, United StatesTaking people
- Rocky Mountain Cancer CentersDenver, United StatesTaking people
- Duke Clinical Research InstituteDurham, United StatesTaking people
- El Paso Texas OncologyEl Paso, United StatesTaking people
- Sarah Cannon Research InstituteNashville, United StatesTaking people
- Texas Oncology - San AntonioSan Antonio, United StatesTaking people
- Lundquist Inst BioMed at HarborTorrance, United StatesTaking people
- Johns Hopkins UniversityWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT05868629
- Record updated
- 1 April 2026
- Original description
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.Read full original descriptionShow less
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
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.
Inclusion: 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: 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.