Actively Recruiting
Pembrolizumab in Locally Advanced Sinonasal Carcinoma
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-04-16
28
Participants Needed
1
Research Sites
153 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 study will test the Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced sinonasal undifferentiated carcinoma (SNUC). Activity of neoadjuvant chemotherapy in locally advanced SNUC has been already demonstrated; the primary hypothesis is that the addition of pembrolizumab as neoadjuvant and adjuvant agent might confirm the results obtained with a combined treatment strategy including chemotherapy, decreasing the burden of treatment-related side effects.
CONDITIONS
Official Title
Pembrolizumab in Locally Advanced Sinonasal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have centrally confirmed, treatment-nafve sinonasal undifferentiated carcinoma (SNUC) that can be cured with local therapies.
- Have locally advanced disease defined as stage III or IVa-b according to AJCC cancer staging system VIII edition.
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age or older at the time of signing informed consent.
- Have measurable disease based on RECIST 1.1 criteria.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Have adequate organ function.
- Male participants must agree to use contraception during treatment and for at least 180 days after the last dose, and refrain from sperm donation during this period.
- Female participants must not be pregnant or breastfeeding and must either not be of childbearing potential or agree to use contraception during treatment and for at least 180 days after the last dose.
- Have provided a tumor tissue sample or a newly obtained biopsy of a tumor lesion, preferably formalin-fixed, paraffin-embedded tissue blocks or new biopsies.
You will not qualify if you...
- Have disease not suitable for curative local therapy, such as severe brain involvement.
- Have metastatic disease defined as stage IVc according to AJCC cancer staging system VIII edition.
- Female participants of childbearing potential with a positive pregnancy test within 72 hours before allocation.
- Have received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other stimulatory or co-inhibitory T-cell receptor agents.
- Have received prior systemic anti-cancer therapy, including investigational agents, before allocation.
- Have received a live vaccine within 30 days before the first dose of study drug.
- Are currently participating or have participated in another investigational study or used an investigational device within 4 weeks before the first dose.
- Have immunodeficiency or are receiving chronic systemic steroid therapy (over 10 mg prednisone daily) or other immunosuppressive treatments within 7 days before the first dose.
- Have a history of a second malignancy unless treated curatively with no evidence of disease for 2 years, with exceptions.
- Have active central nervous system metastases or carcinomatous meningitis.
- Have severe hypersensitivity (grade 3 or higher) to pembrolizumab or its excipients.
- Have active autoimmune disease requiring systemic treatment in the past 2 years.
- Have a history or current pneumonitis/interstitial lung disease requiring steroids.
- Have an active infection requiring systemic therapy.
- Have a known history of HIV infection.
- Have a known history of active Hepatitis B or Hepatitis C infection.
- Have a known history of active tuberculosis.
- Have conditions or abnormalities that may interfere with study participation or results.
- Have psychiatric or substance abuse disorders interfering with study requirements.
- Are pregnant, breastfeeding, or planning to conceive or father children during the study and up to 120 days after last treatment.
- Have had an allogenic tissue or solid organ transplant.
AI-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
L
Laura D Locati, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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