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Pembrolizumab in Locally Advanced Sinonasal Carcinoma

NCT05925491 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-16

No results posted yet for this study

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 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

Interventions

DRUG

Pembrolizumab

Pembrolizumab administration in combination with chemotherapy for 3 cycles, followed by standard of care

DRUG

Cisplatin

Cisplatin 75mg/mq in combination with pembrolizumab 200 mg and docetaxel 75 mg/mq every three weeks (Q3W) for 3 courses.

DRUG

Docetaxel

Docetaxel 75 mg/mq in combination with pembrolizumab 200 mg and cisplatin 75 mg/mq every three weeks (Q3W) for 3 courses.

DRUG

Carboplatin

Carboplatin AUC 5 alternative to Cisplatin if toxicities occur.

Sponsors & Collaborators

Principal Investigators

  • Laura D Locati, MD, PhD · Istituti Clinici Scientifici Maugeri

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-24
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05925491 on ClinicalTrials.gov