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Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Oct 1, 2026 Eligibility criteria expanded, about 32 words · Secondary endpoints revised (8) · Study description expanded, about 9 words · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 9 words
    • Collaborators: details revised at 1 of 1 entry
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Active, Not Recruiting to Completed Primary completion date changed from estimate of Nov 19, 2025 to Jul 21, 2025 · Study completion date changed from estimate of May 2026 to Sep 11, 2025v11 Show 2 more changesShow less
    • Primary completion date changed from estimate of Nov 19, 2025 to Jul 21, 2025
    • Study completion date changed from estimate of May 2026 to Sep 11, 2025
  3. Primary completion date: Nov 19, 2023 to Nov 19, 2025 Completion date: May 2024 to May 2026v10 Show 1 more changeShow less
    • Completion date: May 2024 to May 2026
  4. Re-verified, no change to tracked fieldsv9
  5. Primary completion date: Nov 19, 2021 to Nov 19, 2023 Completion date: May 2023 to May 2024v8 Show 1 more changeShow less
    • Completion date: May 2023 to May 2024
Show 6 earlier versionsHide 6 earlier versions
  1. Completion date: May 2022 to May 2023v7
  2. Lead sponsor: Assuntina G. Sacco, MD to University of California, San Diego Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 83 to confirmed 78 · Primary completion date changed from estimate of Dec 30, 2021 to Nov 19, 2021 · 1 morev6 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 83 to confirmed 78
    • Primary completion date changed from estimate of Dec 30, 2021 to Nov 19, 2021
    • Site details revised at 4 of 4 sites
  3. Lead sponsor: Assuntina G. Sacco to Assuntina G. Sacco, MD Primary completion date: Dec 30, 2019 to Dec 30, 2021 · Completion date: May 2020 to May 2022v5 Show 2 more changesShow less
    • Primary completion date: Dec 30, 2019 to Dec 30, 2021
    • Completion date: May 2020 to May 2022
  4. Primary completion date: May 27, 2019 to Dec 30, 2019 Study sites: 1 to 4v4 Show 1 more changeShow less
    • Study sites: 1 to 4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting Primary completion date: May 2019 to May 27, 2019 · Start date changed from estimate of Mar 2017 to Mar 28, 2017 · Site details revisedv2 Show 3 more changesShow less
    • Primary completion date: May 2019 to May 27, 2019
    • Start date changed from estimate of Mar 2017 to Mar 28, 2017
    • Site details revised
  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.
This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm (Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25 in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive Cancer Center, University of Michigan Comprehensive Cancer Center, and University of Washington Siteman Cancer Center.
Trial Details
NCT Number NCT03082534
Lead Sponsor University of California, San Diego
Collaborators: Merck Sharp & Dohme LLC
Conditions HNSCC, Lip SCC, Oral Cavity Cancer, Oropharynx Cancer, Larynx Cancer, Hypopharynx Cancer, Nasopharynx Cancer, Sinonasal Carcinoma +4 more
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov