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Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 2, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 2025 to Jan 2026
    • Study completion date: Sep 2026 to Jan 2027
    • Site details revised at 10 of 10 sites
    v9
  2. Site details revised at 2 of 10 sitesv8
  3. Re-verified, no change to tracked fieldsv7
  4. Enrollment target: 47 to 50v6 Show 5 more changesShow less
    • Study sites: 9 to 10
    • Eligibility criteria expanded, about 101 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 28 words
    • Study arms: 1 to 2
  5. Site details revised at 2 of 9 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 1 of 9 sitesv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to May 25, 2023
    • Site details revised at 9 of 9 sites
    v3
  3. Lead sponsor: University of Erlangen-Nürnberg Medical School to Universität des Saarlandesv2 Show 4 more changesShow less
    • Primary completion date: Apr 2024 to Sep 2025
    • Start date: Oct 2022 to Mar 2023
    • Study sites: 8 to 9
    • Study completion date: Apr 2026 to Sep 2026
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Open-label, two-arm, prospective multicenter phase II clinical trial to determine the efficacy and safety of combined pembrolizumab and lenvatinib compared to pembrolizumab alone as maintenance therapy after definitive radiochemotherapy of locally advanced head and neck squamous cell carcinoma (HNSCC).
Trial Details
NCT Number NCT05433116
Lead Sponsor Universität des Saarlandes
Conditions
(from sponsor)		 Head and Neck Squamous Cell Carcinoma
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov