Actively Recruiting
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
Led by Saint Petersburg State University, Russia · Updated on 2025-09-05
20
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Immunohistochemically confirmed anaplastic thyroid cancer not suitable for complete (R0-R1) surgery
- Age 18 years or older
- Functional status ECOG 0-2
- Adequate function of internal organs and bone marrow
- Ability to provide written informed consent
You will not qualify if you...
- Presence of BRAF V600 gene mutation without prior targeted therapy with BRAF/MEK inhibitors
- Clinically significant bleeding such as hemoptysis or gastrointestinal bleeding
- Tumor invasion into large blood vessels
- Open wounds or fistulas
- Contraindications to study drugs
- Poor functional status ECOG 3-4
- Continuous use of immunosuppressive therapy
- Prior treatment with investigational drugs
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Saint Petersburg State University Hospital
Saint Petersburg, Russia, 190020
Actively Recruiting
Research Team
I
Ilya Sleptsov, MD
CONTACT
E
Ernest Dzhelialov
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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