Evaluating Dabrafenib and Trametinib for Rare BRAF V600E Mutation-Positive Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Trametinib for Ras/MAPK Pathway Vascular Anomalies in Kids and Teens

  This study tests whether trametinib can help children and young people with Ras/MAPK-driven vascular anomalies.

  Recruiting Phase 2 Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT07549646

• Gefitinib, trametinib, disulfiram, and sunitinib added to standard chemotherapy for metastatic osteosarcoma

  This study tests whether adding gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy helps people with newly diagnosed metastatic osteosarcoma.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07477457

• Dabrafenib and trametinib for rare cancers with BRAF V600 mutations

  This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.

  Recruiting at 15 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT07440290

• Dabrafenib and trametinib dose-reduction for BRAF V600 low-grade glioma

  This trial tries to see if stopping or slowly lowering dabrafenib and trametinib after about 12–24 months works for people with BRAF V600–mutant low-grade glioma.

  Recruiting at 12 sites Phase 2 University of California, San Francisco · Birmingham, Alabama and 11 other locations · NCT07110246

• Dabrafenib or Trametinib plus Clofarabine for high-risk or relapsed pediatric Langerhans cell histiocytosis

  This treatment will test whether adding a MAPK inhibitor (dabrafenib or trametinib) to the chemotherapy drug clofarabine helps children and teens (0–18) with high-risk, recurrent, or refractory Langerhans cell histiocytosis.

  Recruiting Phase 2 West China Second University Hospital · Chengdu, Sichuan · NCT07022834

• Combining Imatinib and Trametinib for KRAS-mutated Solid Tumors

  This study tests if combining two cancer drugs, imatinib and trametinib, can help people with hard-to-treat solid tumors that have KRAS mutations.

  Recruiting Phase 1 China Medical University Hospital · Taichung, Taichung · NCT06962254

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.