RecruitingPhase 2NCT06374602

Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

Sponsor

Saint Petersburg State University, Russia

Enrollment

20 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of two cancer drugs — pembrolizumab (an immunotherapy) and lenvatinib (a targeted therapy) — in people with anaplastic thyroid cancer, one of the most aggressive forms of thyroid cancer, that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of anaplastic thyroid cancer - Your tumor cannot be completely removed with surgery - Your general health is acceptable for treatment (ECOG 0–2) - Your organ function and blood counts meet the required minimums **You may NOT be eligible if...** - You have a BRAF V600 gene mutation and have not yet tried BRAF/MEK targeted therapy - You have significant bleeding, open wounds, or fistulas - Your cancer has grown into major blood vessels - You are already on long-term immune-suppressing medications - You have had prior immunotherapy of the same type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab + Lenvatinib

Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody. Lenvatinib is Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).