Actively Recruiting
Pembrolizumab in High-risk Thyroid Cancer
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-04-20
25
Participants Needed
1
Research Sites
97 weeks
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
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.
CONDITIONS
Official Title
Pembrolizumab in High-risk Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of any gender, aged 18 years or older at the time of informed consent
- Histologically confirmed differentiated thyroid carcinoma planned for surgery and not previously treated
- High risk (>20%) of persistent or recurrent disease based on tumor size, extension, mutation status, lymph node involvement, or expected incomplete resection
- Includes poorly differentiated carcinoma and Hürthle cell carcinoma
- Presence of measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 evaluated within 7 days before randomization
- Adequate organ function as specified by study criteria
- Male participants agree to use contraception during treatment and for at least 6 months after last dose
- Female participants are not pregnant, not breastfeeding, and either not of childbearing potential or agree to contraception during treatment and for at least 4 months after last dose
You will not qualify if you...
- Women of childbearing potential with a positive pregnancy test within 72 hours before randomization
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint agents
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks before randomization
- Prior radiotherapy within 2 weeks before starting study treatment unless meeting specified recovery criteria
- Receipt of live vaccines within 30 days before first dose of study drug
- Participation in other investigational studies or use of investigational devices within 4 weeks before first dose
- Diagnosed immunodeficiency or use of immunosuppressive therapy exceeding specified doses within 7 days before first dose
- History of second malignancy unless disease-free for at least 2 years or specific exceptions
- Active central nervous system metastases or carcinomatous meningitis unless stable and off steroids as specified
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- History of HIV infection
- History of active Hepatitis B or Hepatitis C infection
- Known active tuberculosis
- Conditions or abnormalities interfering with study participation or safety as judged by investigator
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or intending to conceive/father children during study period
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituti Clinici Scientifici Maugeri
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
S
Serena Barbaro, M.Sc.
CONTACT
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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