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Pembrolizumab in Locally Advanced Sinonasal Carcinoma

Study acronym: NeoPeSino
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Nov 2026 to Dec 2026
    • Study completion date: Nov 2026 to Dec 2027
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Dec 24, 2024
    • Site details revised
    v4
  3. Notable Start date: Oct 2024 to Jan 2025v3
  4. Notable Start date: Nov 2023 to Oct 2024
    • Interventions: Pembrolizumab (Drug) to Carboplatin (Drug), Cisplatin (Drug), Docetaxel (Drug), Pembrolizumab (Drug)
    • Site contact updated
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05925491
Lead Sponsor Istituti Clinici Scientifici Maugeri SpA
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)
Sinonasal Undifferentiated Carcinoma
Related terms Sinonasal undifferentiated carcinoma
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov