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NCT06440850

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 2 with changes below, 2 re-verified with no change.

  1. Primary and study completion dates: Nov 30, 2026 to Nov 22, 2026
    • Start date changed from estimate of Nov 30, 2024 to Jul 15, 2024
    v2
  2. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

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

Secondary (4)

Proportion of patients who achieve increased iodine incorporation to a predicted lesion absorbed dose of 2000 cGy with I-131 dose of ≤ 300 mCi
Incidence of treatment related adverse events
Progression free survival
Changes in thyroglobulin levels

Arms and interventions

Treatment (vemurafenib and cobimetinib)Experimental

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.

Procedures: Biospecimen Collection, Computed Tomography, Diagnostic Imaging, I-131 Uptake Test, Magnetic Resonance Imaging, Positron Emission Tomography, Ultrasound Imaging

Drugs: Cobimetinib, Vemurafenib

Radiation: Iodine I-131

Biologicals: Recombinant Thyrotropin Alfa

Sites

1 site in 1 country

  • City of Hope Medical CenterDuarte, California, United States