Triple Drug Therapy for Thyroid Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, if you are on chemotherapy, you must not have received it within 1 week prior to the study. If you are on dabrafenib/trametinib, you may continue according to the standard run-in. Please consult with the trial team for guidance on your specific medications.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on certain treatments like chemotherapy, you may need to wait at least one week before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the idea that Triple Drug Therapy for Thyroid Cancer is an effective treatment?
The available research shows that the combination of Dabrafenib and Trametinib, which are part of the Triple Drug Therapy, has been effective in treating certain types of thyroid cancer, particularly those with a specific mutation called BRAF V600E. In one study, this combination was shown to have a significant impact on survival in patients with anaplastic thyroid cancer, a very aggressive form of the disease. Another study found that Dabrafenib and Trametinib together had a similar response rate to Dabrafenib alone in treating differentiated thyroid cancer that does not respond to radioactive iodine. This suggests that while the combination is effective, it may not always be superior to using Dabrafenib by itself. Overall, these drugs have shown promise in treating thyroid cancer with specific genetic mutations.12345
What data supports the effectiveness of the drug combination Dabrafenib, Trametinib, and Pembrolizumab for thyroid cancer?
Research shows that the combination of Dabrafenib and Trametinib is effective in treating thyroid cancers with specific BRAF mutations, such as anaplastic thyroid cancer, by inhibiting cancer cell growth. Although Pembrolizumab is not specifically mentioned in these studies, it is known to enhance the immune system's ability to fight cancer in other contexts.12345
What safety data exists for triple drug therapy in thyroid cancer?
The safety data for the combination of Dabrafenib, Trametinib, and Pembrolizumab in thyroid cancer shows that common adverse events include skin disorders, fever, hyperglycemia, nausea, chills, and fatigue. No treatment-related deaths were reported. The combination therapy was generally well tolerated, with no new safety signals detected. These findings are based on multiple studies evaluating the efficacy and safety of Dabrafenib and Trametinib in BRAF V600E-mutated thyroid cancers, including differentiated and anaplastic types.12346
Is the triple drug therapy for thyroid cancer safe for humans?
The combination of Dabrafenib and Trametinib has been studied in thyroid cancer patients and is generally well tolerated, with common side effects including skin issues, fever, fatigue, and nausea. No treatment-related deaths were reported, and no new safety concerns were identified in the studies.12346
Is the drug combination of Dabrafenib, Pembrolizumab, and Trametinib promising for thyroid cancer?
Yes, the combination of Dabrafenib and Trametinib shows promise for treating a specific type of thyroid cancer with a BRAF V600E mutation. It has been effective in improving survival rates and has been well tolerated by patients, representing a significant advancement for this rare and aggressive cancer.23467
What makes the triple drug therapy for thyroid cancer unique?
What is the purpose of this trial?
This phase II trial studies the effect of pembrolizumab, dabrafenib, and trametinib before surgery in treating patients with BRAF V600E-mutated anaplastic thyroid cancer. BRAF V600E is a specific mutation (change) in the BRAF gene, which makes a protein that is involved in sending signals in cells and in cell growth. It may increase the growth and spread of tumor cells. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab, dabrafenib, and trametinib may help to control BRAF V600E-mutated anaplastic thyroid cancer when given before surgery.
Research Team
Mark Zafereo
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with anaplastic thyroid cancer that has a specific BRAF V600E gene mutation. Participants must have measurable disease, agree to biopsies and surgery if possible, not be pregnant or breastfeeding, use contraception, and have good organ function and performance status. Exclusions include significant heart issues, untreated brain metastases, active autoimmune diseases requiring treatment within the past 2 years, severe allergies to pembrolizumab or its components.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Phase
Patients receive dabrafenib, trametinib, and pembrolizumab before surgery to assess tumor response and resectability
Surgery
Patients undergo surgery if the disease is deemed resectable after neoadjuvant treatment
Adjuvant Phase
Post-surgery, patients may receive pembrolizumab and undergo IMRT with or without additional chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dabrafenib
- Pembrolizumab
- 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?
M.D. Anderson Cancer Center
Lead Sponsor