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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
Subjects must be willing to ultimately undergo surgery if their tumor becomes surgically resectable. Research subjects retain the right to refuse any research interventions
Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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...
I am open to surgery if my tumor can be removed.
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My tests show I have anaplastic thyroid cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I agree to use contraception and not donate sperm for 8 months after my last treatment dose.
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My blood clotting time is normal or managed if I'm on blood thinners.
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I am willing to have a tumor biopsy before and after starting treatment, unless my doctor thinks it's unsafe.
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I am not pregnant or breastfeeding and either cannot become pregnant or agree to use contraception.
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My tumor has a BRAFV600E mutation.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete gross surgical resection (R0 or R1 resection)
Overall survival (OS)
Secondary outcome measures
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 moreTrial 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
~1550
Pembrolizumab
2017
Completed Phase 2
~2010
Conventional Surgery
2006
Completed Phase 3
~1080
Dabrafenib
2011
Completed Phase 3
~4120
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,772 Total Patients Enrolled
1 Trials studying Thyroid Carcinoma
3,400 Patients Enrolled for Thyroid Carcinoma
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being actively recruited for this clinical trial?
"From what is detailed on clinicaltrials.gov, this trial appears to be ongoing and looking for new participants. The listing was first posted on June 24th, 2021 and last updated October 4th, 2022. They are hoping to enroll 30 patients at 3 different locations."
Answered by AI
Does the FDA approve of Quality-of-Life Assessment?
"There is some data supporting the safety of Quality-of-Life Assessment, but none yet for efficacy. We've given it a score of 2."
Answered by AI
Could you share some other papers that focus on Quality-of-Life Assessment?
"There are 1088 active clinical trials investigating Quality-of-Life Assessment with 128 trials in Phase 3. While several of the trials for Quality-of-Life Assessment are based in Rochester, Minnesota, there are 41708 locations operating trials for Quality-of-Life Assessment."
Answered by AI
What are investigators hoping to understand by conducting this research?
"This trial will last for up to 72 months and assess whether patients can undergo complete gross surgical resection (R0 or R1 resection). Secondary outcomes that will be measured include patient-reported symptoms (using the MDASI-HN instrument), tumor response (using RECIST v1.1), and locoregional control (defined as time from start of any trial treatment to first locoregional recurrence/progression event)."
Answered by AI
How many individuals are part of this experiment?
"Yes, this is an ongoing recruiting trial that was first posted on 6/24/2021 as indicated by the clinicaltrials.gov website. The study is seeking 30 participants from 3 different locations and was most recently edited on 10/4/2022."
Answered by AI
What does Quality-of-Life Assessment usually address?
"Quality-of-Life Assessment is a treatment that is sometimes used for malignant neoplasms, but it can also be effective in treating conditions like unresectable melanoma and microsatellite instability high."
Answered by AI
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