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.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Cincinnati, Denver, Durham, El Paso, Nashville, San Antonio, Torrance, and Washington D.C., United StatesSee the 8 sites
- Trial code
- 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
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 6 Feb 2024
- Expected to end
- 3 Mar 2028
- Type of study
- Observational
- Treatments tested
- Non-investigational
- Record updated
- 1 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children (1 year or older) and adults whose rare solid tumor has spread or cannot be removed by surgery, and whose tumor has a BRAF V600E mutation. Doctors have already decided to treat them with dabrafenib and trametinib.
- Age
- From 1 year to 100 years
- Sex
- Women and men can join
- Disease stage
- Rare solid tumor that cannot be removed by surgery or has spread, with at least 1 lesion that can be measured (RECIST v1.1)
- Earlier treatment
- Must not have had dabrafenib and/or trametinib before. People who had them for another cancer can join if treatment stopped more than 1 year ago.
- Biomarker or test result
- BRAF V600E mutation in the tumor, confirmed by a local laboratory test
Main reasons for not taking part
- Melanoma, NSCLC, ATC, BTC, glioma or CRC tumor types
- A medical reason (contraindication) that rules out dabrafenib and/or trametinib according to the local label
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in United States
- Oncology Hematology Care, IncCincinnati, United StatesContact: Douglas HartTaking people
- Rocky Mountain Cancer CentersDenver, United StatesContact: Sierra ArchuletaTaking people
- Duke Clinical Research InstituteDurham, United StatesContact: Kim Turnage ScogginsTaking people
- El Paso Texas OncologyEl Paso, United StatesContact: Nicole DeanTaking people
- Sarah Cannon Research InstituteNashville, United StatesContact: Brianah FerbyTaking people
- Texas Oncology - San AntonioSan Antonio, United StatesContact: Norma NorrisTaking people
- Lundquist Inst BioMed at HarborTorrance, United StatesContact: Steve YoonTaking people
- Johns Hopkins UniversityWashington D.C., United StatesContact: Kai HajosTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- dabrafenib plus trametinib
patients treated with dabrafenib and trametinib
Treatment: Non-investigational
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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
- Plain-language title
- Follows patients with rare BRAF V600E solid tumors taking dabrafenib and trametinibGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05868629, who can take part
- Record updated
- 1 April 2026