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Kinase Inhibitor

Vemurafenib + Cobimetinib for Thyroid Cancer

Phase 2

Recruiting

Led By Sasan Fazeli

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Males or females aged ≥ 18 years at the time of informed consent

Patients with thyroid carcinoma of follicular origin (papillary, follicular or Hurthle cell)

Must not have

Subjects having > 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24 h will be ineligible

Need for locoregional treatment such as surgery, external beam radiation or thermoablation at inclusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well vemurafenib and cobimetinib work in treating patients with high-risk thyroid cancer that has a specific genetic mutation. These medications work by blocking abnormal proteins that signal

Who is the study for?

This trial is for patients with high-risk differentiated thyroid carcinoma that has a specific BRAFV600E gene mutation. It's aimed at those preparing for radioactive iodine therapy.

What is being tested?

The effectiveness of vemurafenib and cobimetinib, both kinase inhibitors, is being tested to see if they can better prepare patients with the BRAFV600E mutation for radioactive iodine treatment by slowing cancer growth.

What are the potential side effects?

Possible side effects include fatigue, skin rash, joint pain, nausea, liver problems, heart issues, and vision changes due to the action of kinase inhibitors on abnormal proteins in cancer cells.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My thyroid cancer is of follicular origin.

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My cancer has a positive BRAFV600E mutation.

Exclusion Criteria

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

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My urine protein levels are below 1 g/24 h.

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I need surgery or radiation therapy at the start of the trial.

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I cannot undergo radioactive iodine treatment.

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I have had serious heart issues or uncontrolled high blood pressure recently.

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I have not had major surgery in the last 4 weeks.

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I have not coughed up significant blood or had bleeding issues recently.

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I am not pregnant or breastfeeding.

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I have previously undergone radioactive iodine treatment.

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I have taken medications like sorafenib or trametinib for cancer.

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My thyroid cancer is of a specific type (undifferentiated or MTC).

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I am currently on medication for an infection.

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I have had a retinal vein occlusion before.

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I have had central serious retinopathy in the past.

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My thyroid cancer is not considered high risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year after treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to radioactive iodine therapy

Secondary study objectives

Incidence of treatment related adverse events

Progression free survival

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 (vemurafenib and cobimetinib)Experimental Treatment11 Interventions

Patients receive vemurafenib PO BID for 6 weeks and cobimetinib PO QD for 3 weeks, followed by 1 week off, and then continuing for 2 weeks. Patients then receive iodine 131 PO followed by 3 additional days of vemurafenib PO BID and cobimetinib PO QD. Patients receive thyrogen IM daily for 2 days followed by I-123 diagnostic scan during screening and on study. Patients also undergo MRI during screening, PET scan or CT scan and blood sample collection throughout the study and ultrasound imaging and I-131 whole body scan during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Ultrasound Imaging

2018

Completed Phase 4

~760