RecruitingPhase 2NCT05852223

Pembrolizumab in High-risk Thyroid Cancer

Neoadjuvant Pembrolizumab in High-risk Thyroid Cancers


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

25 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This window of opportunity trial is studying a checkpoint inhibitor agent to treat differentiated thyroid cancer in a neoadjuvant setting. A checkpoint inhibitor is a compound aimed at restoring tumor immunosurveillance. The name of this agent is pembrolizumab.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding Pembrolizumab — an immunotherapy drug that helps the immune system fight cancer — before and after surgery improves outcomes for people with high-risk thyroid cancer. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of differentiated thyroid cancer (a type of thyroid cancer) that has not yet been treated - Your cancer is considered high risk: large tumor (over 4 cm), spread outside the thyroid, spread to lymph nodes, or has distant spread to other parts of the body - You have not yet received any cancer treatment - You are otherwise healthy enough to undergo surgery and treatment **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have previously received immunotherapy (anti-PD-1 or similar drugs) - You have received other cancer treatments within the past 4 weeks - You have an active autoimmune disease or conditions that suppress your immune system - You have had severe immune-related reactions to prior therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Neoadjuvant pembrolizumab 200mg Q3W will be administered via IV infusion for 2 courses from the date of randomization until to the date of thyroidectomy.


Locations(1)

Istituti Clinici Scientifici Maugeri

Pavia, Lombardy, Italy

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NCT05852223


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