Evaluating Dabrafenib and Trametinib for Rare BRAF V600E Mutation-Positive Tumors
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 tests if the medications dabrafenib and trametinib can help people aged 6 and older with rare tumors that have a specific BRAF mutation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 1 Year to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | trametinib |
| Locations | 8 sites (Torrance, California and 7 other locations) |
| Trial ID | NCT05868629 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy of dabrafenib and trametinib in patients with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors. Participants, aged 6 years and older, will be treated with these medications as part of their standard care, regardless of their involvement in the trial. The study will include patients who have not previously received these treatments, ensuring a focus on new cases. The effectiveness will be assessed through measurable lesions as defined by RECIST criteria.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 6 years or older with a confirmed BRAF V600E mutation-positive solid tumor and at least one measurable lesion.
Not a fit: Patients with specific tumor types such as melanoma, non-small cell lung cancer, and colorectal cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with rare BRAF V600E mutation-positive tumors, potentially improving their outcomes.
How similar studies have performed: Other studies have shown promising results with similar approaches using dabrafenib and trametinib for BRAF V600E mutations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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, ATC, BTC, glioma and CRC; * Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;
Where this trial is running
Torrance, California and 7 other locations
- Lundquist Inst BioMed at Harbor — Torrance, California, United States (Recruiting)
- Rocky Mountain Cancer Centers — Denver, Colorado, United States (Recruiting)
- Johns Hopkins University — Washington D.C., District of Columbia, United States (Recruiting)
- Duke Clinical Research Institute — Durham, North Carolina, United States (Recruiting)
- Oncology Hematology Care Inc — Cincinnati, Ohio, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- El Paso Texas Oncology — El Paso, Texas, United States (Recruiting)
- Texas Oncology San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.