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NCT06374602RecruitingPhase 2

Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
First submitted
27 Mar 2024
Start date
25 Mar 2024
Primary completion date
25 Mar 2026
Lead sponsor
Saint Petersburg State University, Russia
NCT number
NCT06374602

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 20
  • From 25 Mar 2024 to the primary completion date, 25 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF/MEK inhibitors;
  • contraindications to taking any of the studied drugs;
  • continuous use of immunosuppressive therapy;
  • prior therapy with investigational drugs;

Other illness

  • patients with clinically significant hemoptysis and bleeding (for example, from the gastrointestinal tract or tumor-associated bleeding);

Other

  • tumor invasion into large vessels;
  • patients with open wounds and fistulas;
  • patients with poor functional status (ECOG 3-4);
  • pregnancy, breast-feeding

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Saint Petersburg State University Hospital
Coordinator of this site? Confirm its status
Saint PetersburgRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.