Dabrafenib + Trametinib for Brain Tumors
Trial Summary
What is the purpose of this trial?
This trial is studying the effects of two cancer medications, dabrafenib and trametinib, in children. These drugs work by stopping signals that make cancer cells grow. Dabrafenib and trametinib have shown benefits in various BRAF-mutant tumors, including melanoma, lung cancer, and thyroid cancer. The goal is to see how these treatments affect children over time.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must already be receiving dabrafenib and/or trametinib treatment to participate.
What data supports the effectiveness of the drug combination Dabrafenib and Trametinib for treating brain tumors?
Research shows that the combination of Dabrafenib and Trametinib is effective in treating brain tumors with a specific mutation (BRAF V600E). It has been approved by the FDA for treating low-grade glioma in children, showing a higher response rate compared to other treatments. Additionally, it has shown positive results in treating other cancers with the same mutation, like melanoma, which often spreads to the brain.12345
Is the combination of Dabrafenib and Trametinib safe for humans?
How is the drug Dabrafenib + Trametinib unique for treating brain tumors?
Dabrafenib + Trametinib is unique because it targets the BRAF V600E mutation, a common driver in some brain tumors, and has shown dramatic clinical responses and reduced skin-related side effects compared to other treatments. This combination has been effective in treating other cancers with the same mutation, like melanoma, and is now being explored for brain tumors.12478
Research Team
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
This trial is for pediatric patients with various brain tumors who are already participating in Novartis-sponsored studies and receiving dabrafenib/trametinib. They must have shown compliance, be likely to benefit from continued treatment, and not have severe unresolved toxicities related to the drugs. Those previously on chemotherapy can join after switching to the experimental arm.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dabrafenib and/or trametinib as per their previous treatment in the parent study
Long-term Follow-up
Participants are monitored for long-term effects, including developmental and clinical assessments
Treatment Details
Interventions
- Dabrafenib
- Trametinib
Dabrafenib is already approved in European Union, United States, Canada, Japan for the following indications:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600E mutation
- Adjuvant treatment of melanoma with a BRAF V600E or V600K mutation
- Metastatic non-small cell lung cancer with a BRAF V600E mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD