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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
Must not have
Previous documentation or current evidence of treatment with dabrafenib and trametinib
Current interstitial lung disease or pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.
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.
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 below
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I can swallow and keep down pills.
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My thyroid cancer is confirmed to have the BRAF-V600E mutation.
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I am 18 years old or older.
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My cancer has spread or cannot be surgically removed for a cure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with dabrafenib and trametinib.
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I have interstitial lung disease or pneumonitis.
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I am HIV-positive and on combination antiretroviral therapy.
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I have been treated with idelalisib before.
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I have a history or current signs of heart disease risk.
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I have been diagnosed with active tuberculosis in the past.
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I have had retinal vein occlusion or central serous retinopathy.
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I cannot receive immunotherapy due to specific reasons.
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I have hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate per RECIST 1.1 Criteria

Side effects data

From 2021 Phase 3 trial • 552 Patients • NCT03551626
68%
Pyrexia
32%
Headache
30%
Blood creatine phosphokinase increased
27%
Diarrhoea
26%
Fatigue
26%
Chills
24%
Asthenia
23%
Nausea
21%
Arthralgia
21%
Rash
15%
Vomiting
15%
Myalgia
14%
Alanine aminotransferase increased
14%
Cough
13%
Lipase increased
13%
Aspartate aminotransferase increased
12%
Influenza like illness
12%
Oedema peripheral
9%
Pain in extremity
8%
Neutropenia
8%
Abdominal pain
8%
Constipation
8%
Muscle spasms
7%
Back pain
7%
Blood alkaline phosphatase increased
7%
Decreased appetite
7%
Hypophosphataemia
7%
Dyspnoea
7%
Erythema
7%
Hypertension
6%
Amylase increased
6%
Hyperglycaemia
6%
Dry skin
6%
Dizziness
5%
Abdominal pain upper
5%
Pain
5%
Pruritus
5%
Oropharyngeal pain
3%
Ejection fraction decreased
1%
Atrial fibrillation
1%
Erysipelas
1%
Cellulitis
1%
Basal cell carcinoma
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dabrafenib+Trametinib (On-treatment)
Dabrafenib+Trametinib (Post-treatment Follow-up)

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
~3420
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,541 Total Patients Enrolled
Eric Sherman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
91 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04238624 — Phase 2
Thyroid Cancer Research Study Groups: BRAF-mutant ATC
Thyroid Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04238624 — Phase 2
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04238624 — Phase 2
~2 spots leftby Jun 2025
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