Pembrolizumab and Lenvatinib/Chemotherapy for Poorly Differentiated/Anaplastic Thyroid Cancer (NCT04731740) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate (ORR)
Timeframe: prior to study completion, average 3 years
2
Overall survival at 6 months in cohort Lenvatinib+Pembrolizumab
. Ability to collect samples, including blood and tumors, for translational studies.
Exclusion criteria
. The presence of a confirmed BRAF mutation.
. Concurrent participation in another clinical trial if it is not an observational (non-interventional) clinical trial or during the follow-up period of an interventional trial
. Pretreatment with any immune checkpoint inhibitor therapy (eg anti-CTLA4, -PD-1 or -PD-L1).
. Taking any type of low molecular weight kinase inhibitors (including the investigational kinase inhibitor) for 2 weeks or 5 half-lives of the agent, whichever is greater.
. Receiving any type of anti-tumor antibodies (including test antibodies) or systemic chemotherapy within 2 weeks before starting treatment.
. Current or previous use of immunosuppressants within 2 weeks prior to the first dose of study drugs, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses that should not exceed 10 mg / day of prednisone or an equivalent corticosteroid.
. Active or previously documented autoimmune disease within the past 2 years. Note: Patients with vitiligo, Graves' disease or psoriasis who do not require systemic treatment (within the last 2 years) are not excluded.
. Active or previously documented inflammatory bowel disease (eg Crohn's disease and ulcerative colitis).