NCT05852223

Pembrolizumab in High-risk Thyroid Cancer

Neoadjuvant Pembrolizumab in High-risk Thyroid Cancers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a window of opportunity trial. The window of opportunity trial investigates the metabolic and/or the pharmacodynamic effect of a compound, exploiting the window of time between the diagnosis and the start of treatment, e.g surgical intervention. Pembrolizumab has been approved by FDA and EMA for several type of cancers. Pembrolizumab has not been approved for treatment against thyroid cancers. Pembrolizumab is a checkpoint inhibitor, it binds the protein PD-1 on the surface on immune cells (T cells) interrupting the cross talk with its ligands, PD-L1 and PD-L2, on cancer cells, allowing the immune system to recognize and destroy the cancer cells.

Conditions

• Differentiated Thyroid Cancer

Interventions

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

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-05-10
• Last updated: 2025-04-13

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study