Your session is about to expire
← Back to Search
Protein Kinase Inhibitor
Triple Drug Therapy for Thyroid Cancer
Phase 2
Recruiting
Led By Mark Zafereo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma
Must have a BRAFV600E mutation-positive tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue, genetic/molecular testing of tumor, or cell free (cf)NDA liquid biopsy
Must not have
Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG [or hCG]). A women of childbirth potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to the first infusion will be excluded. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
A known history of retinal vein occlusion (RVO), central serous retinopathy (CSR), uncontrolled glaucoma or ocular hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combo of 3 drugs to treat patients with a specific mutation in their cancer cells. The drugs work by either stopping cell growth or by helping the body's immune system attack the cancer.
Who is the study for?
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.
What is being tested?
The study tests the combination of pembrolizumab (an immune system booster), dabrafenib and trametinib (which block enzymes aiding tumor growth) before surgery in patients with a certain type of thyroid cancer. The goal is to see if this pre-surgery treatment can help control the cancer better.
What are the potential side effects?
Possible side effects include allergic reactions to medication components; inflammation in organs due to immune response; liver enzyme changes; fatigue; skin rash; fever; coughing or shortness of breath from lung inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show I have anaplastic thyroid cancer.
Select...
My tumor has a BRAFV600E mutation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Select...
I have a history of serious eye conditions like RVO, CSR, or uncontrolled glaucoma.
Select...
I have or had lung inflammation not caused by infection, treated with steroids.
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
Select...
I have serious heart issues, worse than mild symptoms.
Select...
I have brain metastases that have not been treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete gross surgical resection (R0 or R1 resection)
Overall survival (OS)
Secondary study objectives
Health related quality of life
Locoregional control
Number of patients with adverse events as a measure of safety of neoadjuvant dabrafenib, trametinib, and pembrolizumab
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dabrafenib, trametinib, pembrolizumab)Experimental Treatment6 Interventions
Patients receive 21-day cycles of dabrafenib 150 mg orally (PO) twice daily from Days 1-21, trametinib 2mg PO once daily from Days 1-21, and pembrolizumab 200mg intravenously (IV) on Day 1 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1630
Pembrolizumab
2017
Completed Phase 3
~3130
Conventional Surgery
2006
Completed Phase 3
~1080
Dabrafenib
2011
Completed Phase 3
~4120
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,072 Previous Clinical Trials
1,803,196 Total Patients Enrolled
Mark ZafereoPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L.You have a disease that can be measured using specific guidelines.You have enough infection-fighting white blood cells in your body.I am not pregnant or breastfeeding.Your platelet count is at least 100 billion per liter.I have a history of serious eye conditions like RVO, CSR, or uncontrolled glaucoma.You have a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.I am open to surgery if my tumor can be removed.My tests show I have anaplastic thyroid cancer.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have or had lung inflammation not caused by infection, treated with steroids.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use contraception and not donate sperm for 8 months after my last treatment dose.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have been on DT therapy for more than 30 days before joining.My blood clotting time is normal or managed if I'm on blood thinners.Your AST and ALT levels in your blood are not more than 2.5 times the upper limit of normal. If you have liver metastases, these levels should not be more than 5 times the upper limit of normal.Your total bilirubin level should be within a certain range, unless you have Gilbert's syndrome, in which case it can be a bit higher.I am willing to have a tumor biopsy before and after starting treatment, unless my doctor thinks it's unsafe.I have serious heart issues, worse than mild symptoms.I have brain metastases that have not been treated.I have not received a live vaccine within the last 30 days.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use contraception.You have a history of HIV or active hepatitis B or hepatitis C infection. If you had hepatitis B in the past, you may be eligible, but you will be monitored for reactivation. If you had hepatitis C in the past, you may be eligible only if tests show that the virus is not currently active.My tumor has a BRAFV600E mutation.I haven't had chemotherapy in the last week or still have side effects from previous treatments, except if I was on DT as per trial rules.Your kidney function, as measured by a blood test for creatinine, is within a certain range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (dabrafenib, trametinib, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.