This study evaluates the combination of lenvatinib with denosumab in bone-predominant
metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas. All patients will
receive this combination of treatments.
Patients are usually considered for directed therapy (radiotherapy and/or surgery and/or
thermo-ablation) in case of symptomatic lesions or at high risk of local complications. They
also usually receive systemic bone-directed agents (bisphosphonate or denosumab), despite
sparse available data in the context of differentiated thyroid carcinomas (DTC). As
bone-directed agents have no antitumor activity, patients may require additional treatments.
To date, only sorafenib and lenvatinib have been approved in the treatment of advanced
Radioiodine Refractory Differentiated Thyroid Carcinomas (RR-DTC).
Lenvatinib demonstrated efficacy in RR-DTC compared to placebo. While other kinase inhibitors
appeared to be less effective in controlling bone metastatic disease compared to other soft
tissue sites, lenvatinib showed, in a small number of patients, significant decrease in bone
Even if both study drugs are indicated in the treatment of patients suffering from RR-DTC
with bone metastases, it is of essential importance to confirm that lenvatinib can provide
clinical benefit and antitumor activity when combined with denosumab in this population.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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