Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
NCT ID: NCT06374602
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2024-03-25
2026-06-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pembrolizumab and Lenvatinib/Chemotherapy for Poorly Differentiated/Anaplastic Thyroid Cancer
NCT04731740
Nivolumab Plus Lenvatinib Against Anaplastic Thyroid Cancer (NAVIGATION)
NCT05696548
Phase II Study Assessing the Efficacy and Safety of Lenvatinib for Anaplastic Thyroid Cancer
NCT02726503
Study of Sinibolimab Combined with Lenvatinib As Neoadjuvant Therapy for Locally Advanced Unresectable Differentiated Thyroid Carcinoma
NCT06848920
Induction Chemotherapy and Toripalimab Followed by Radiotherapy in Unresectable Laryngeal/Hypopharyngeal Carcinoma
NCT05420597
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Scientific hypothesis: the combination of pembrolizumab and lenvatinib is effective and safe in patients with anaplastic thyroid cancer.
Trial design, materials and methods: this study is a pilot Phase 2 study. This study is prospective and open-label. Patients who meet the criteria will be treated with a combination of pembrolizumab and lenvatinib and outcomes will be assessed according to primary and secondary endpoints.
All patients will receive one regimen of antitumor treatment (exploratory therapy). The control will be carried out by monitoring the initial state in dynamics.
Before starting research therapy, data will be recorded for each patient in an individual registration card.
Before starting research therapy, clinical and laboratory parameters will be evaluated and computed tomography of the brain, neck, thoracic and abdominal cavities with intravenous contrast will be performed (initial assessment of the prevalence of the tumor process).
Mutations in the BRAF V600 gene, microsatellite instability (MSI) and PD-L1 expression will be determined in the tumor material (first of all), and the following molecular genetic variants will be determined in the second place (planned): RET, NTRK, ALK, ROS1.
Research therapy includes pembrolizumab 200 mg intravenously for 30 minutes (cycle 21 days) in combination with targeted therapy with lenvatinib 20 mg (2 capsules of 10 mg 1 time per day daily). Dose modification in case of toxicity for pembrolizumab is not provided. For lenvatinib, a sequential dose reduction is provided depending on the previous level (14 mg, 10 mg, 8 mg). When the dose is reduced, a return to the previous level is not carried out.
Duration of treatment: pembrolizumab - up to 35 cycles, until progression or intolerable toxicity, depending on what comes first. Lenvatinib - before progression or intolerable toxicity.
Follow-up period of patients:
follow-up during active treatment within the framework of the study - before progression or intolerable toxicity; patient survival monitoring - documenting subsequent lines of antitumor treatment before the patient's death or loss of contact with him; patient safety monitoring - 30 and 90 days from the date of the final dose.
Assessment of the response to treatment (assessment of clinical and laboratory parameters, computed tomography of the brain, neck, thoracic and abdominal cavities with intravenous contrast) will be carried out monthly or according to clinical indications in the first 6 months, then - according to the decision of the research team. Based on the results of the control study, the response to treatment will be evaluated according to the iRECIST criteria. Patients who meet the criteria for progression will be excluded from the study.
When converting a tumor to resectability and planning surgical treatment, it is recommended to suspend taking lenvatinib at least a week before surgery and resume taking it at least 2 weeks after. There is no relationship between pembrolizumab and complications associated with surgical treatment, and no interruptions in treatment are required.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
Pembrolizumab + Lenvatinib
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody. Lenvatinib is Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pembrolizumab + Lenvatinib
Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody. Lenvatinib is Lenvatinib is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Saint Petersburg State University, Russia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ernest Dzhelialov
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Saint Petersburg State University Hospital
Saint Petersburg, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
33
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.