Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

Launched by SAINT PETERSBURG STATE UNIVERSITY, RUSSIA · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe two medications, pembrolizumab and lenvatinib, are for treating patients with a type of cancer called anaplastic thyroid cancer. The trial is specifically looking at patients who have not received treatment before and do not have a certain genetic mutation known as BRAF. Participants must be at least 18 years old and have a certain level of health that allows them to take part in the study.

If you or a loved one qualify for this trial, you can expect to receive both medications and be monitored for their effects. The study is currently recruiting patients, so there’s an opportunity to join if you meet the criteria. It’s important to know that certain conditions, like having specific mutations or serious health issues, might make someone ineligible for this trial. This is a chance to possibly access new treatments while contributing to important research.

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Eligibility criteria

• 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