WithdrawnPhase 2

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

Stopped: Lack of funding

Russia0Started 2020-12-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female subjects ≥ 18 years of age.
✓. Willingness to participate in the research by signing an informed consent form approved by the research ethics committee.
✓. ECOG status 0 or 1 or 2.
✓. Measurable disease according to RECIST 1.1, as defined by the investigator.
✓. Patients with a histologically confirmed disease (according to the pathologist's report) that meets one of the following criteria (according to the 2010 WHO classification):
✓. Radioactive iodine resistant disease (RAI), which is defined by one or more of the following criteria:
✓. Patients with inoperable locally advanced disease or metastases. Patients who do not want to undergo surgery or radiation are also eligible. Patients with the BRAFV600E mutation who are unable to take FDA-approved drugs, dabrafenib / trametinib, or established progression with therapy are eligible for study treatment if documented.
✓. Ability to collect samples, including blood and tumors, for translational studies.

Exclusion criteria

What they're measuring

Overall response rate (ORR)

Timeframe: prior to study completion, average 3 years

Overall survival at 6 months in cohort Lenvatinib+Pembrolizumab

Timeframe: 6 months

Trial details

NCT IDNCT04731740

SponsorSaint Petersburg State University, Russia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-28

View on ClinicalTrials.gov More Metastatic Thyroid Gland Carcinoma trials