Sinonasal Undifferentiated CarcinomaPhase 2NeoPeSinoNCT05925491
Pembrolizumab in Locally Advanced Sinonasal Carcinoma
A Phase 2 study testing Pembrolizumab, Cisplatin and Docetaxel in people with Sinonasal Undifferentiated Carcinoma, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinonasal Undifferentiated Carcinoma
- What is being tested?
- Pembrolizumab, Cisplatin and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 24 Dec 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies.
- Have locally advanced disease defined as stage III of IV a-b according to American Joint Committee on Cancer (AJCC) cancer staging system VIII edition.
- Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- Be ≥ 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1 as determined by the site.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
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- Demonstrate adequate organ function.
- A male participant must agree to use contraception during the treatment period and for at least 180 days after last dose, corresponding to time needed to eliminate any study treatments plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity. He must refrain from donating sperm during this period, too.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- o Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees use contraception during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatments plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.
- Have provided tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).
- 2. Have metastatic disease defined as stage IV c according to AJCC cancer staging system VIII edition.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
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- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ (eg, breast carcinoma or cervical cancer in situ that have undergone potentially curative therapy are not excluded
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA qualitative is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri
Pavia, Lombardy, 27100
Serena Barbaro, M.Sc., +39 (0)382592326, CTCstaff.pavia@icsmaugeri.it
Laura D Locati, MD, PhD
About this study
Official title: Neoadjuvant Pembrolizumab Plus Chemotherapy in Locally Advanced Sinonasal Carcinoma
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
- Sinonasal Undifferentiated Carcinoma
- Being tested
- Pembrolizumab, Cisplatin, Docetaxel, Carboplatin
- Keywords
- Sinonasal Undifferentiated Carcinoma, SNUC, neoadjuvant immunotherapy, neoadjuvant treatment, locally advanced, pembrolizumab, neoadjuvant
- Medical subject headings
- Sinonasal undifferentiated carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab administration in combination with chemotherapy for 3 cycles, followed by standard of care
CisplatinDrug
Cisplatin 75mg/mq in combination with pembrolizumab 200 mg and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses.
DocetaxelDrug
Docetaxel 75 mg/mq in combination with pembrolizumab 200 mg and cisplatin 75 mg/mq every three weeks (Q3W) for 3 courses.
CarboplatinDrug
Carboplatin AUC 5 alternative to Cisplatin if toxicities occur.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Pembrolizumab | Experimental | Patients will receive pembrolizumab 200 mg + cisplatin 75mg/mq (or Carboplatin AUC 5) and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses, followed by standard of care. Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neoadjuvant therapy objective response rate (ORR)
ORR defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1
Measured: Up to 24 months after the end of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start24 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinonasal Undifferentiated CarcinomaStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Laura D Locati, MD, PhD, Principal investigator, Istituti Clinici Scientifici Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925491
- Sponsor's protocol ID
- NeoPeSino
- Acronym
- NeoPeSino
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Pembrolizumab Plus Chemotherapy in Locally Advanced Sinonasal Carcinoma
- ClinicalTrials.gov ID
- NCT05925491
- Acronym / sponsor ID
- NeoPeSino / NeoPeSino
- Conditions
- Sinonasal Undifferentiated Carcinoma
- Keywords
- Sinonasal Undifferentiated Carcinoma, SNUC, neoadjuvant immunotherapy, neoadjuvant treatment, locally advanced, pembrolizumab, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Pembrolizumab | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Drug: Docetaxel, Drug: CarboplatinPatients will receive pembrolizumab 200 mg + cisplatin 75mg/mq (or Carboplatin AUC 5) and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses, followed by standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies.
- Have locally advanced disease defined as stage III of IV a-b according to American Joint Committee on Cancer (AJCC) cancer staging system VIII edition.
- Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- Be ≥ 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1 as determined by the site.
Key exclusion criteria (22 listed)
- Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).
- 2. Have metastatic disease defined as stage IV c according to AJCC cancer staging system VIII edition.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab administration in combination with chemotherapy for 3 cycles, followed by standard of care | Drug | Neoadjuvant Pembrolizumab |
| CisplatinCisplatin 75mg/mq in combination with pembrolizumab 200 mg and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses. | Drug | Neoadjuvant Pembrolizumab |
| DocetaxelDocetaxel 75 mg/mq in combination with pembrolizumab 200 mg and cisplatin 75 mg/mq every three weeks (Q3W) for 3 courses. | Drug | Neoadjuvant Pembrolizumab |
| CarboplatinCarboplatin AUC 5 alternative to Cisplatin if toxicities occur. | Drug | Neoadjuvant Pembrolizumab |
Primary outcome
Neoadjuvant therapy objective response rate (ORR)
Time frame: Up to 24 months after the end of neoadjuvant treatment
ORR defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura D Locati, MD, PhD principal investigator
Istituti Clinici Scientifici Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Cisplatin and Docetaxel in people with Sinonasal Undifferentiated Carcinoma, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serena Barbaro, M.Sc. (+39 (0)3982592326, CTCstaff.pavia@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neoadjuvant therapy objective response rate (ORR) (time frame: Up to 24 months after the end of neoadjuvant treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.