Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06440850
Phase
PHASE2
Status
Recruiting
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Conditions

  • Thyroid Gland Follicular Carcinoma
  • Thyroid Gland Oncocytic Carcinoma
  • Thyroid Gland Papillary Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cobimetinib — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Diagnostic Imaging — PROCEDURE
    Undergo I-123 diagnostic scan
  • I-131 Uptake Test — PROCEDURE
    Undergo I-131 whole body scan
  • Iodine I-131 — RADIATION
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Recombinant Thyrotropin Alfa — BIOLOGICAL
    Given IM
  • Ultrasound Imaging — PROCEDURE
    Undergo neck ultrasound
  • Vemurafenib — DRUG
    Given PO

Study Details

This phase II trial tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. Vemurafenib and cobimetinib are used in patients whose cancer has a mutated (changed) form of a gene called BRAF. They are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving vemurafenib and cobimetinib may work better to treat patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy.

Key Dates

Start date
Jul 15, 2024
Status verified
Jan 2026
Primary completion
Nov 22, 2026
Completion
Nov 22, 2026

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (vemurafenib and cobimetinib)
    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.

Primary Outcome Measure

Patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to radioactive iodine therapy [ Time Frame: Up to completion of 6 week vemurafenib and cobimetinib therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Sasan Fazeli
[email protected]
626-256-4673
Sasan Fazeli (PRINCIPAL_INVESTIGATOR)

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City of Hope Medical Center· Duarte, CA

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