NCT06374602 Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
| NCT ID | NCT06374602 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Saint Petersburg State University, Russia |
| Condition | Anaplastic Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2026-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-03-25 with a primary completion date of 2026-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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); * continuous use of immunosuppressive therapy; * prior therapy with investigational drugs; * pregnancy, breast-feeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06374602 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anaplastic Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06374602 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06374602 currently recruiting?
Yes, NCT06374602 is actively recruiting participants. Contact the research team at newsurgery@yandex.ru for enrollment information.
Where is the NCT06374602 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06374602 clinical trial?
NCT06374602 is sponsored by Saint Petersburg State University, Russia. The trial plans to enroll 20 participants.
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