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Protein Kinase Inhibitor

Triple Drug Therapy for Thyroid Cancer

Phase 2

Recruiting

Led By Mark Zafereo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma

Must have a BRAFV600E mutation-positive tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue, genetic/molecular testing of tumor, or cell free (cf)NDA liquid biopsy

Must not have

Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG [or hCG]). A women of childbirth potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to the first infusion will be excluded. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

A known history of retinal vein occlusion (RVO), central serous retinopathy (CSR), uncontrolled glaucoma or ocular hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 months

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults with anaplastic thyroid cancer that has a specific BRAF V600E gene mutation. Participants must have measurable disease, agree to biopsies and surgery if possible, not be pregnant or breastfeeding, use contraception, and have good organ function and performance status. Exclusions include significant heart issues, untreated brain metastases, active autoimmune diseases requiring treatment within the past 2 years, severe allergies to pembrolizumab or its components.

What is being tested?

The study tests the combination of pembrolizumab (an immune system booster), dabrafenib and trametinib (which block enzymes aiding tumor growth) before surgery in patients with a certain type of thyroid cancer. The goal is to see if this pre-surgery treatment can help control the cancer better.

What are the potential side effects?

Possible side effects include allergic reactions to medication components; inflammation in organs due to immune response; liver enzyme changes; fatigue; skin rash; fever; coughing or shortness of breath from lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tests show I have anaplastic thyroid cancer.

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My tumor has a BRAFV600E mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a history of serious eye conditions like RVO, CSR, or uncontrolled glaucoma.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have serious heart issues, worse than mild symptoms.

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I have brain metastases that have not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete gross surgical resection (R0 or R1 resection)

Overall survival (OS)

Secondary study objectives

Health related quality of life

Locoregional control

Number of patients with adverse events as a measure of safety of neoadjuvant dabrafenib, trametinib, and pembrolizumab

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dabrafenib, trametinib, pembrolizumab)Experimental Treatment6 Interventions

Patients receive 21-day cycles of dabrafenib 150 mg orally (PO) twice daily from Days 1-21, trametinib 2mg PO once daily from Days 1-21, and pembrolizumab 200mg intravenously (IV) on Day 1 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1630

Pembrolizumab

2017

Completed Phase 3

~3150