Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

Summary

This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints.

Eligibility

Inclusion Criteria:

* immunohistochemically verified anaplastic thyroid cancer that is not eligible to R0-R1 surgery;
* age ≥ 18 years;
* functional status of ECOG 0-2;
* adequate function of internal organs and bone marrow;
* the ability to give written informed consent.

Exclusion Criteria:

* patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors;
* patients with clinically significant hemoptysis and bleeding (for example, from the gastrointestinal tract or tumor-associated bleeding);
* tumor invasion into large vessels;
* patients with open wounds and fistulas;
* contraindications to taking any of the studied drugs;
* patients with poor functional status (ECOG 3-4);
* continuous use of immunosuppressive therapy;
* prior therapy with investigational drugs;
* pregnancy, breast-feeding

Conditions2

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