Combining Pembrolizumab and Lenvatinib for Anaplastic Thyroid Cancer
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
This study is testing if a combination of two drugs, pembrolizumab and lenvatinib, can help people with anaplastic thyroid cancer who haven't been treated before.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Petersburg State University, Russia Academic / other |
| Drugs / interventions | pembrolizumab, lenvatinib |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT06374602 on ClinicalTrials.gov |
What this trial studies
This pilot phase 2 study evaluates the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer who are treatment-naive and BRAF-negative. The study is prospective and open-label, where eligible patients will receive a regimen of these two therapies, and their outcomes will be assessed based on predefined primary and secondary endpoints. Prior to treatment, patients will undergo comprehensive clinical evaluations and imaging to assess tumor prevalence and relevant genetic mutations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with immunohistochemically verified anaplastic thyroid cancer that is not eligible for surgery.
Not a fit: Patients with a mutation in the BRAF V600 gene who have not previously undergone targeted therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a new effective treatment option for patients with anaplastic thyroid cancer.
How similar studies have performed: While the combination of pembrolizumab and lenvatinib is being explored, similar approaches in other cancers have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint Petersburg
- Saint Petersburg State University Hospital — Saint Petersburg, Russia (Recruiting)
Study contacts
- Study coordinator: Ilya Sleptsov, MD
- Email: newsurgery@yandex.ru
- Phone: +7(921)951-70-88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.