Triple Drug Therapy for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of three drugs—pembrolizumab, dabrafenib (a BRAF inhibitor), and trametinib—to determine their effectiveness in treating BRAF V600E-mutated anaplastic thyroid cancer. The aim is to shrink tumors before surgery by halting their growth and aiding the immune system in attacking cancer cells. Individuals with this type of thyroid cancer and a BRAF V600E mutation may be suitable candidates for the trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that the combination of pembrolizumab, dabrafenib, and trametinib holds promise for treating thyroid cancer with the BRAF V600E mutation. Research suggests that this treatment can control tumor growth and improve surgical outcomes.
The safety data is encouraging. Previous research has not reported any treatment-related deaths. These drugs have been used in other studies and are generally well-tolerated. Most side effects, if they occur, are usually manageable and not life-threatening.
This treatment is currently in a Phase 2 trial, indicating it has passed initial safety tests in humans. Researchers are still gathering more information to confirm its safety and effectiveness.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of dabrafenib, trametinib, and pembrolizumab for thyroid cancer because it targets the disease in a way current treatments don't. Most existing options focus on traditional chemotherapy or radioactive iodine treatment, but this triple therapy combines targeted therapy and immunotherapy. Dabrafenib and trametinib specifically target the BRAF mutation and MEK pathway, which are often involved in thyroid cancer growth, while pembrolizumab stimulates the immune system to attack cancer cells. This multi-faceted approach could potentially offer more effective treatment, especially for patients whose cancers are resistant to standard therapies.
What evidence suggests that this trial's treatments could be effective for BRAF V600E-mutated anaplastic thyroid cancer?
Research has shown that combining the drugs dabrafenib, trametinib, and pembrolizumab may effectively treat BRAF V600E-mutated anaplastic thyroid cancer. This trial will evaluate the effectiveness of this combination. Studies have found that dabrafenib and trametinib work well together against this cancer. Adding pembrolizumab, an immune therapy, might enhance the treatment by strengthening the immune system to fight cancer cells. In earlier trials, patients taking dabrafenib and trametinib lived without cancer progression for an average of 6.7 months and had an overall survival time of 13.5 months. With pembrolizumab added, researchers hope for even better results.12346
Who Is on the Research Team?
Mark Zafereo
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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