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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of pembrolizumab combined with lenvatinib in patients with anaplastic thyroid cancer. This pilot Phase 2 study includes both treatment-naive patients without BRAF mutations and patients previously treated with chemotherapy or targeted therapies. The study aims to assess outcomes based on specific primary and secondary endpoints to better understand this treatment combination's potential in this aggressive cancer. Participants receive pembrolizumab intravenously every 21 days at a dose of 200 mg, combined with daily oral lenvatinib starting at 20 mg. Dose reductions for lenvatinib are allowed if toxicity occurs, but pembrolizumab dose changes are not planned. Treatment continues until cancer progression or intolerable side effects, with pembrolizumab given up to 35 cycles. Patients undergo thorough initial evaluations including scans and genetic testing before starting therapy. During the study, participants will have monthly assessments for the first six months, including clinical exams, lab tests, and imaging to monitor tumor response using iRECIST criteria. Safety is closely monitored at every treatment visit and for up to 90 days after treatment ends. Patient survival and any further cancer treatments are tracked until death or loss of contact. Treatment breaks for surgery are planned if the tumor becomes operable, with specific guidance on managing lenvatinib around surgery.
CONDITIONS
Brief Title
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed anaplastic thyroid cancer not eligible for complete surgical removal
- Age 18 years or older
- ECOG functional status of 0 to 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, including hemoptysis or tumor-related bleeding
- Tumor invasion into large blood vessels
- Presence of open wounds or fistulas
- Contraindications to pembrolizumab or lenvatinib
- Poor functional status (ECOG 3 to 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 35 cycles of pembrolizumab (approximately up to 2 years) or until progression or intolerable toxicity
Participants receive pembrolizumab intravenously every 21 days combined with daily oral lenvatinib until disease progression or intolerable toxicity.
Visits every 21 days for treatment and safety assessments; monthly imaging assessments during the first 6 months
Duration - Up to 90 days after treatment ends
Participants are monitored for survival, subsequent antitumor treatments, and safety for up to 90 days after the last dose.
Visits at 30 and 90 days post-treatment
Trial Site Locations
Total: 1 location
1
Saint Petersburg State University Hospital
Saint Petersburg, Russia, 190020
Actively Recruiting
Research Team
I
Ilya Sleptsov, MD
E
Ernest Dzhelialov
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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