Actively Recruiting
Neoadjuvant Pembrolizumab Treatment for High-risk Differentiated Thyroid Cancer Before Surgery
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-04-20
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituti Clinici Scientifici Maugeri SpA
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of pembrolizumab, a checkpoint inhibitor, in treating differentiated thyroid cancer before surgery in a neoadjuvant setting. This trial focuses on high-risk thyroid cancer patients and explores how pembrolizumab affects immune cells that may help the body recognize and attack cancer cells. Pembrolizumab has been approved for other cancers but is being studied here specifically for thyroid cancer in a Phase 2 randomized trial. Participants are divided into two groups: one group of about 20 patients will receive pembrolizumab 200 mg through intravenous infusion every three weeks for two doses, followed by thyroid surgery with or without radioiodine treatment based on risk. The other group of about 5 patients will receive the usual care, which is surgery followed by optional radioiodine treatment. The trial investigates the effects of pembrolizumab during the time between diagnosis and surgery, known as the window of opportunity. During the study, participants will be closely monitored through tissue and blood tests to observe changes in exhausted cytotoxic T cells up to 12 months after surgery. Researchers will assess immune responses and other clinical outcomes related to the treatment. The trial includes regular evaluations of organ function and performance status, with follow-up lasting up to one year after surgery to understand the immune system's behavior and treatment impact.
CONDITIONS
Brief Title
Pembrolizumab in High-risk Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Histologically confirmed differentiated thyroid carcinoma eligible for surgery
- Patients with high risk (>20%) for persistent or recurrent disease based on tumor size, extension, mutation status, or lymph node involvement
- Includes poorly differentiated carcinoma and Hurtle cell carcinoma
- Patients with distant metastasis at diagnosis
- Written informed consent provided
- Measurable disease based on RECIST 1.1 criteria
- ECOG performance status between 0 and 1 within 7 days before randomization
- Adequate organ function as defined by study requirements
- Male participants must agree to use contraception during treatment and for 6 months after last dose
- Female participants must not be pregnant or breastfeeding and follow contraceptive guidance if of childbearing potential
You will not qualify if you...
- Positive pregnancy test within 72 hours prior to randomization for women of childbearing potential
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or related immune checkpoint agents
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks before randomization
- Radiotherapy within 2 weeks before study intervention, with some exceptions
- Live vaccines within 30 days before first dose of study drug
- Participation in other investigational studies or devices within 4 weeks prior
- Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent within 7 days before first dose
- History of second malignancy unless cured for at least 2 years (with some exceptions)
- Known active CNS metastases or carcinomatous meningitis
- Severe hypersensitivity to pembrolizumab or its excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- History of HIV, Hepatitis B or C infection unless cleared
- Known active tuberculosis
- Conditions or therapies interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnancy, breastfeeding, or planning conception during study duration
- History of allogenic tissue or solid organ transplant
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive neoadjuvant pembrolizumab 200 mg by IV infusion every three weeks for 2 courses before thyroid surgery.
2 infusion visits over 6 weeks
Duration - Up to 1 week
Participants undergo thyroidectomy following pembrolizumab treatment, with additional radioiodine treatment based on risk classification.
1 surgical visit (in-person)
Duration - Up to 12 months
Participants are monitored for up to 12 months after surgery to study treatment effects and recovery.
Regular follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Istituti Clinici Scientifici Maugeri
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
S
Serena Barbaro, M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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