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Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 186 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 200 sites
  2. Site details revised at 1 of 200 sites
  3. Site details revised at 2 of 200 sites
  4. Study sites revised (200)
  5. Site details revised at 2 of 200 sites
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 199 to 200
  2. Secondary endpoints: details revised at 5 of 5 entries Site details revised at 13 of 199 sites Show 1 more changeShow less
    • Site details revised at 13 of 199 sites
  3. Re-verified, no change to tracked fieldsv179
  4. Site details revised at 4 of 199 sitesv178
  5. Site details revised at 4 of 199 sitesv177
  1. Trial sites expanded: 193 → 199 locationsv176
  2. Study sites: 192 to 193v175
  3. Site details revised at 1 of 192 sitesv174
  4. Study sites revised (192)v173 See this version in full on ClinicalTrials.gov ↗
  5. Site contacts updated at 9 of 192 sitesv172
  6. Site details revised at 1 of 192 sitesv171
  7. Trial sites expanded: 177 → 192 locationsv170
  8. Site details revised at 1 of 177 sitesv169
  9. Site details revised at 3 of 177 sitesv168
  10. Re-verified, no change to tracked fieldsv167
  11. Site details revised at 2 of 177 sitesv166
  12. Re-verified, no change to tracked fieldsv165
  13. Site contacts updated at 1 of 177 sitesv164
  14. Re-verified, no change to tracked fieldsv163
  15. Study sites: 176 to 177v162
  16. Site details revised at 1 of 176 sitesv161
  17. Site details revised at 1 of 176 sitesv160
  18. Site details revised at 1 of 176 sitesv159
  19. Site details revised at 1 of 176 sitesv158
  20. Site details revised at 1 of 176 sitesv157
  21. Site details revised at 1 of 176 sitesv156
  22. Site details revised at 6 of 176 sitesv155
  23. Site details revised at 6 of 176 sitesv154
  24. Re-verified, no change to tracked fieldsv153
  25. Study sites: 175 to 176v152
  26. 3 versions Re-verified since Apr 1, 2026, no change to tracked fieldsv149-v151
  27. Site details revised at 1 of 175 sitesv148
  28. 7 versions Re-verified since Mar 20, 2026, no change to tracked fieldsv141-v147
  29. Study Status, Contacts/Locationsv140
  30. 3 versions Re-verified since Mar 14, 2026, no change to tracked fieldsv137-v139
  • 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 phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.
Trial Details
NCT Number NCT06589804
Lead Sponsor National Cancer Institute (NCI)
Conditions Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma +13 more
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov