Clinical trial · Interventional
Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
NCT06374602CI-TRIAL-00094591recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Thyroid Cancer | Thyroid Gland Anaplastic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab + Lenvatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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).
- interventionNames
- Drug: Pembrolizumab + Lenvatinib
Primary outcomes (3)
- measure
- Objective response rate
- timeFrame
- 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
- description
- The proportion of participants with a partial or complete response to the therapy. It is determined according to the iRECIST criteria.
- measure
- Progression-Free Survival
- timeFrame
- 6-month, 1-year, 2-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.