Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Russian Federation
Saint Petersburg State University Hospital
RECRUITING
Saint Petersburg
Contact Information
Primary
Ilya Sleptsov, MD
newsurgery@yandex.ru
+7(921)951-70-88
Backup
Ernest Dzhelialov
ernest.dzhelialov@gmail.com
+7(911)134-50-44
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2026-06-25
Participants
Target number of participants: 20
Treatments
Experimental: Intervention group
Treatment-naive patients with BRAF-negative anaplastic thyroid cancer and previously treated patients, including patients with BRAF-positive anaplastic thyroid cancer (resistant to anti-BRAF therapy).
Related Therapeutic Areas
Sponsors
Leads: Saint Petersburg State University, Russia