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FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

Study acronym: FORTIFI-HN01
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 203 → 231 locations Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 7 of 11 entries · Study description expanded, about 3 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 7 of 11 entries
    • Study description expanded, about 3 words
  2. Trial sites reduced: 207 → 203 locationsv28
  3. Trial sites expanded: 173 → 207 locationsv27
  4. Trial sites expanded: 161 → 173 locationsv26
  5. Trial sites expanded: 129 → 161 locationsv25
Show 23 earlier versionsHide 23 earlier versions
  1. Study sites: 125 to 129v24
  2. Study sites: 111 to 125 Eligibility criteria shortened, about 6 wordsv23 Show 1 more changeShow less
    • Eligibility criteria shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 100 to 111v22
  4. Study sites: 97 to 100v21
  5. Study sites: 91 to 97v20
  6. Study sites: 64 to 91v19
  7. Study sites: 59 to 64v18
  8. Study sites: 58 to 59v17
  9. Study sites: 52 to 58v16
  10. Study sites: 50 to 52v15
  11. Study sites: 46 to 50v14
  12. Study sites: 44 to 46v13
  13. Study sites: 39 to 44v12
  14. Study sites: 34 to 39v11
  15. Study sites: 29 to 34v10
  16. Study sites: 25 to 29v9
  17. Study sites: 22 to 25v8
  18. Study sites: 16 to 22v7
  19. Start date: Dec 20, 2024 to Jan 28, 2025 Study sites: 7 to 16v6 Show 1 more changeShow less
    • Study sites: 7 to 16
  20. Study sites: 5 to 7v5
  21. Study sites: 4 to 5v4
  22. Study sites: 2 to 4v3
  23. Secondary endpoints: details revised at 2 of 11 entries Site contacts updated at 2 of 2 sites · Study title shortened, about 2 wordsv2 Show 2 more changesShow less
    • Site contacts updated at 2 of 2 sites
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Trial Details
NCT Number NCT06788990
Lead Sponsor Bicara Therapeutics
Conditions Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov