drugset / Trial / NCT04731740

Pembrolizumab and Lenvatinib/Chemotherapy for Poorly Differentiated/Anaplastic Thyroid Cancer

NCT04731740 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The aim of the study is to evaluate the efficacy of the combination of lenvatinib with pembrolizumab, and to establish a safe and effective systemic treatment regimen for patients with metastatic anaplastic thyroid cancer (ATC) / poorly differentiated thyroid cancer (PDTC). Lenvatinib is an anti-angiogenic and antiproliferative drug used in differentiated thyroid cancer. It blocks proliferative genes such as RET and PDGFR and further inhibits major proliferation pathways such as VEGF receptor signaling and FGFR1-4. Pembrolizumab is an immune checkpoint inhibitor that targets PD-1 located on lymphocytes. The response to pembrolizumab treatment is associated, among other things, with increased expression of PD-L1, as well as with the frequency of somatic mutations in the respective tumors. Patients with ATC / PDTC show high expression of PD-L1.

Timeline

Start
2020-12-28
Primary completion
2023-12-28
Completion
2023-12-28

Outcome

Outcome not reported

Stopped (Business): “Lack of funding”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule — Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous