Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Feb 28, 2028 → Feb 28, 2029
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Feb 28, 2028 to Feb 28, 2029
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Site details revised at 1 of 5 sites
  2. Site details revised at 1 of 5 sitesv21
  3. Study sites: 4 to 5v20
  4. Site details revised at 1 of 4 sitesv19
  5. Site details revised at 1 of 4 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 2 to 4v17
  2. Primary and study completion dates: Feb 28, 2027 to Feb 28, 2028v16
  3. Site contacts updated at 1 of 2 sitesv15
  4. Eligibility criteria expanded, about 1 wordv14
  5. Site details revised at 1 of 2 sitesv13
  6. Study sites: 1 to 2v12
  7. Secondary endpoints: 5 to 7v11
  8. Re-verified, no change to tracked fieldsv10
  9. Eligibility criteria expanded, about 12 words
    • Site contact updated
    v9
  10. Primary and study completion dates: Apr 30, 2025 to Feb 28, 2027v8
  11. Re-verified, no change to tracked fieldsv7
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 30, 2022 to Apr 6, 2022
    • Site details revised
    v6
  13. Start date: Feb 28, 2022 to Apr 30, 2022
    • Primary and study completion dates: Feb 28, 2025 to Apr 30, 2025
    v5
  14. Collaborators: 1 to 2v4
  15. Start date: Dec 31, 2021 to Feb 28, 2022
    • Primary and study completion dates: Dec 31, 2024 to Feb 28, 2025
    v3
  16. Start date: Sep 30, 2021 to Dec 31, 2021
    • Primary and study completion dates: Oct 31, 2024 to Dec 31, 2024
    • Secondary endpoints: details revised at 1 of 5 entries
    v2
  1. Study First Submitted
  • 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 multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).
Trial Details
NCT Number NCT04966481
Lead Sponsor Washington University School of Medicine
Collaborators: Pfizer, The Joseph Sanchez Foundation
Conditions
(from sponsor)		 HPV-unrelated Head and Neck Squamous Cell Carcinoma
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov