Tests pembrolizumab and lenvatinib for anaplastic thyroid cancer
Tests two cancer drugs, pembrolizumab and lenvatinib, in adults with anaplastic thyroid cancer.
Plain-language title generated from the registry record
Registry title: Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
Key facts
- Where
- Saint Petersburg, RussiaSee the site
- Phase
- Phase 2
Where in Russia
- Saint Petersburg State University HospitalSaint Petersburg, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Saint Petersburg State University, Russia
- Trial code
- NCT06374602
- Record updated
- 5 September 2025
- Original description
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.Read full original descriptionShow less
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
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.
Inclusion: 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: patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors; contraindications to taking any of the studied drugs; continuous use of immunosuppressive therapy; prior therapy with investigational drugs; 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; patients with poor functional status (ECOG 3-4); pregnancy, breast-feeding.