Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

Recruiting now · Phase 2

Conditions studied: Anaplastic Thyroid Cancer

In brief

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.

Key facts

Study ID

NCT06374602

Run by

Saint Petersburg State University, Russia

People needed

20

Starts

2024-03-25

Expected to finish

2026-06-25

Last updated by the study team

2025-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Saint Petersburg State University Hospital — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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