Study on Pembrolizumab, Dabrafib, and Trametinib Before Surgery for Treating BRAF-Mutated Anaplastic Thyroid Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04675710

Provider View

This clinical trial is testing a combination of drugs, pembrolizumab, dabrafenib, and trametinib, given before surgery to see if they can help control anaplastic thyroid cancer with a specific BRAF mutation. The study aims to find out if this treatment can shrink tumors and improve survival rates.

Patient Parameters

Program Overview

This study is exploring whether a combination of three drugs—pembrolizumab, dabrafenib, and trametinib—can help control anaplastic thyroid cancer with a specific BRAF V600E mutation when given before surgery. Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells, while dabrafenib and trametinib are targeted therapies that block certain proteins needed for cancer cell growth. The goal is to see if this combination can shrink tumors and improve outcomes for patients with this aggressive type of thyroid cancer.

Description

The study is divided into different parts:

Part 1 (Neoadjuvant Phase): Patients will take dabrafenib and trametinib pills daily for three weeks. Starting in the fourth week, they will also receive pembrolizumab through an IV every three weeks. This treatment cycle repeats up to three times unless the cancer progresses or side effects become too severe. If the cancer can be surgically removed after this treatment, patients will undergo surgery. If not, they will move to Part 3.

Part 2 (Adjuvant Phase): After surgery, patients may continue receiving pembrolizumab every three weeks and undergo radiation therapy for six weeks. Some patients may also continue taking dabrafenib and trametinib during this time.

Part 3: Patients who cannot have surgery will continue taking dabrafenib and trametinib and receive pembrolizumab every three weeks for up to 17 cycles, as long as the treatment is effective and side effects are manageable.

After completing the study treatment, patients will have follow-up visits every three months for the first two years, every six months for the next two years, and then annually.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with anaplastic thyroid cancer, including specific types like undifferentiated or poorly differentiated carcinoma.
  • Tumor must have a BRAF V600E mutation, confirmed by specific tests.
  • Have measurable cancer based on standard criteria.
  • Meet specific blood test requirements for liver and kidney function, blood cell counts, and clotting ability.
  • Be willing to undergo surgery if the tumor becomes removable.
  • Have a performance status indicating they are fully active or have some restrictions but can still perform light work.
  • Provide written informed consent to participate.
  • Men must agree to use contraception during treatment and for eight months after the last dose.
  • Women must not be pregnant or breastfeeding and must agree to use contraception during treatment and for six months after the last dose.

Exclusion Criteria

  • Have significant heart problems or untreated brain metastases.
  • Have received chemotherapy within one week before starting the study or have not recovered from previous treatment side effects.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Have a history of HIV or active hepatitis B or C infection.
  • Have a diagnosis of immunodeficiency or are taking high-dose steroids or other immunosuppressive drugs.
  • Have received a live vaccine within 30 days before starting the study.
  • Have severe allergies to pembrolizumab or its ingredients.
  • Have a history of lung disease requiring steroids or current lung disease.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Women who are pregnant or breastfeeding.
  • Have been on dabrafenib and trametinib for more than 42 days before joining the study.
  • Have a history of certain eye conditions like retinal vein occlusion or uncontrolled glaucoma.

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