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Triple Drug Therapy for Thyroid Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (dabrafenib, trametinib, pembrolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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)."
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."
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."
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