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Tests treatment safety and results for Anaplastic Thyroid Cancer
Official title Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer
ClinicalTrials.gov ID: NCT06374602
What this study is testing
What is Pembrolizumab + Lenvatinib?
Pembrolizumab + Lenvatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anaplastic thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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);
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.