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Monoclonal Antibodies
Triple Drug Therapy for Thyroid Cancer
Phase 2
Recruiting
Led By Eric Sherman, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow and retain orally administered medication
Pathological (histologically or cytologically) proven diagnosis of BRAF-V600E mutant ATC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if a triple combination of drugs is more effective than the standard two-drug therapy for anaplastic thyroid cancer.
Who is the study for?
This trial is for adults with anaplastic thyroid cancer that has a specific BRAF-V600E mutation. It's open to those who haven't been cured by surgery, can undergo biopsies, and have measurable disease. Participants need normal heart function and organ health, must not be pregnant, agree to use contraception, and be able to take oral meds.Check my eligibility
What is being tested?
The study tests if adding cemiplimab (a new drug) to standard treatment with dabrafenib and trametinib improves outcomes in anaplastic thyroid cancer. Patients will receive this combination therapy and their response will be monitored.See study design
What are the potential side effects?
Cemiplimab may cause immune-related side effects like inflammation of organs or skin rashes. Dabrafenib and trametinib could lead to fever, fatigue, skin problems, heart issues or eye problems among other side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
Select...
My thyroid cancer is confirmed to have the BRAF-V600E mutation.
Select...
I am 18 years old or older.
Select...
My cancer has spread or cannot be surgically removed for a cure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate per RECIST 1.1 Criteria
Trial Design
1Treatment groups
Experimental Treatment
Group I: BRAF-mutant ATCExperimental Treatment2 Interventions
Participants will have a diagnosis of BRAF-V600E mutant Anaplastic Thyroid Cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
Trametinib
2014
Completed Phase 2
~1550
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,874 Total Patients Enrolled
Eric Sherman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
91 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with dabrafenib and trametinib.I do not have any severe illnesses that would stop me from following the study's requirements.My organ and bone marrow functions are normal.I have interstitial lung disease or pneumonitis.I can swallow and keep down pills.I am HIV-positive and on combination antiretroviral therapy.My thyroid cancer is confirmed to have the BRAF-V600E mutation.I have been treated with idelalisib before.I have a history or current signs of heart disease risk.I have been diagnosed with active tuberculosis in the past.I have brain metastases but might get an exception.Your disease must be able to be measured using specific criteria called RECIST 1.1.I am mostly able to care for myself but may not be able to do active work.Your heart's pumping ability is normal according to the tests done at the hospital.I have had retinal vein occlusion or central serous retinopathy.I am 18 years old or older.I cannot receive immunotherapy due to specific reasons.My cancer has spread or cannot be surgically removed for a cure.I have hepatitis B or C.I agree to have 2-4 biopsies of my cancerous lesion.
Research Study Groups:
This trial has the following groups:- Group 1: BRAF-mutant ATC
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.
What other steps have been taken to test Dabrafenib?
"As of right now, there are a total of 99 ongoing clinical trials that are researching Dabrafenib. 6 out of those active investigations are currently in Phase 3. Although the majority of these studies originated from Duarte, California, there are 5810 different locations running Dabrafenib trials."
Answered by AI
How many people are signed up to take part in this experiment?
"That is correct. The clinical trial, which was posted on 1/20/2020 and last edited on 7/1/2022, is still recruiting patients. They are looking for a total of 15 individuals who are willing to participate at one of the seven sites."
Answered by AI
Is Dabrafenib a risky medication?
"There is limited data available on Dabrafenib's safety, as it is still in Phase 2 of clinical trials."
Answered by AI
Are there any opportunities for people to participate in this research project?
"The trial is still ongoing and actively recruiting patients, according to the website clinicaltrials.gov. The study was first posted on 1/20/2020, with the most recent update being on 7/1/2022."
Answered by AI
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