Triple Drug Therapy for Thyroid Cancer

Recruiting at9 trial locations

Overseen by Eric Sherman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is being done to see if adding the study drug, cemiplimab, to the standard therapy with dabrafenib and trametinib is an effective treatment against anaplastic thyroid cancer.

Research Team

Eric Sherman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My organ and bone marrow functions are normal.

I can swallow and keep down pills.

Negative pregnancy test within 14 days of registration for women of childbearing potential

Exclusion 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.

I have interstitial lung disease or pneumonitis.

Treatment Details

Interventions

• Cemiplimab (Monoclonal Antibodies)
• Dabrafenib (Kinase Inhibitor)
• Trametinib (Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: BRAF-mutant ATC Experimental Treatment 2 Interventions

Participants will have a diagnosis of BRAF-V600E mutant Anaplastic Thyroid Cancer

Cemiplimab is already approved in Canada, Brazil for the following indications:

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University