Combining Pembrolizumab and Lenvatinib for Anaplastic Thyroid Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot phase 2 study evaluates the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer who are treatment-naive and BRAF-negative. The study is prospective and open-label, where eligible patients will receive a regimen of these two therapies, and their outcomes will be assessed based on predefined primary and secondary endpoints. Prior to treatment, patients will undergo comprehensive clinical evaluations and imaging to assess tumor prevalence and relevant genetic mutations.

Why it matters

Who can join: the full rules

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

Where it's running

• Saint Petersburg State University Hospital
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Ilya Sleptsov, MD
• Email: newsurgery@yandex.ru
• Phone: +7(921)951-70-88

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.