NCT05868629Recruiting
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 11 May 2023
- Start date
- 6 Feb 2024
- Primary completion date
- 3 Mar 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT05868629
What you commit to
- Study type: Observational
- Planned participants: 40
- From 6 Feb 2024 to the primary completion date, 3 Mar 2028
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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;
Who the study is looking for
- 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
Age in the registry: 1 year to 100 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Hematology Care, Inc Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Rocky Mountain Cancer Centers Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Duke Clinical Research Institute Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| El Paso Texas Oncology Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Texas Oncology - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Lundquist Inst BioMed at Harbor Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.