Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Petersburg State University, Russia

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Pembrolizumab + Lenvatinib

Treatment groups

20 Participants
are divided into 1 treatment group