Anaplastic Thyroid CancerPhase 2NCT06374602
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
A Phase 2 study testing Pembrolizumab + Lenvatinib in people with Anaplastic Thyroid Cancer, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Thyroid Cancer
- What is being tested?
- Pembrolizumab + Lenvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 25 Mar 2024to 25 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors;
- 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);
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- continuous use of immunosuppressive therapy;
- prior therapy with investigational drugs;
- pregnancy, breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Saint Petersburg State University Hospital
Saint Petersburg, 190020
Ernest Dzhelialov, +7(911)134-50-44, ernest.dzhelialov@gmail.com
About this study
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 the detailed description
The aim of the study was to demonstrate the efficacy and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer.
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
- Anaplastic Thyroid Cancer
- Being tested
- Pembrolizumab + Lenvatinib
- Keywords
- Anaplastic thyroid cancer, Immunotherapy, Targeted therapy, Lenvatinib, Pembrolizumab
- Medical subject headings
- Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab + LenvatinibDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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). Receives: Drug: Pembrolizumab + Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of participants with a partial or complete response to the therapy. It is determined according to the iRECIST criteria.
Measured: Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Progression-Free Survival
The time from the date of treatment initiation to the radiological progression or death of the patient for any reason.
Measured: 6-month, 1-year, 2-year
Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events)
Safety assessment will be assessed on the basis of adverse events (according to CTCAE 5.0)
Measured: Each visit (every 21 days) assessed up to 48 months
Secondary outcomes (2)
Overall survival
The time from the start date of treatment to the death of the patient for any reason.
Measured: 6-month, 1-year, 2-year
The assessment of conversion to resectability
The proportion of participants with an initially unresectable or potentially resectable tumor who have moved to a resectable during treatment.
Measured: Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start25 Mar 2024
- Primary completion25 Mar 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernest Dzhelialov, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374602
- Sponsor's protocol ID
- 33
- Status last verified
- Aug 2025
- First submitted
- 27 Mar 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06374602
- Acronym / sponsor ID
- 33
- Conditions
- Anaplastic Thyroid Cancer
- Keywords
- Anaplastic thyroid cancer, Immunotherapy, Targeted therapy, Lenvatinib, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the study was to demonstrate the efficacy and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Pembrolizumab + LenvatinibTreatment-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab + LenvatinibPembrolizumab 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). | Drug | Intervention group |
Primary outcome
Objective response rate
Time frame: Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
The proportion of participants with a partial or complete response to the therapy. It is determined according to the iRECIST criteria.
Progression-Free Survival
Time frame: 6-month, 1-year, 2-year
The time from the date of treatment initiation to the radiological progression or death of the patient for any reason.
Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events)
Time frame: Each visit (every 21 days) assessed up to 48 months
Safety assessment will be assessed on the basis of adverse events (according to CTCAE 5.0)
2 secondary outcomes
Overall survival
Time frame: 6-month, 1-year, 2-year
The assessment of conversion to resectability
Time frame: Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab + Lenvatinib in people with Anaplastic Thyroid Cancer, run by Saint Petersburg State University, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilya Sleptsov, MD (+7(921)951-70-88, newsurgery@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Each month from date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.