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A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

Study acronym: AHEAD-MERIT
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 145 → 142 locations Eligibility criteria expanded, about 16 words · Secondary endpoints: details revised at 2 of 8 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 8 entries
  2. Enrollment closed, study ongoing Trial sites reduced: 195 → 145 locations · Enrollment target: estimated 350 to confirmed 358v57 Show 2 more changesShow less
    • Trial sites reduced: 195 → 145 locations
    • Enrollment target: estimated 350 to confirmed 358
  3. Primary and study completion moved earlier from Apr 2029 to Aug 2028 Site details revised at 145 of 195 sitesv56 Show 1 more changeShow less
    • Site details revised at 145 of 195 sites
  4. Site details revised at 3 of 195 sitesv55
  5. Study sites: 193 to 195v54
  6. Trial sites expanded: 190 → 193 locationsv53
  7. Study sites: 189 to 190v52
  8. Site details revised at 17 of 189 sitesv51
  9. Site details revised at 17 of 189 sitesv50
  10. Study sites: 188 to 189v49
  11. Site details revised at 1 of 188 sitesv48
  12. Study sites: 187 to 188v47
  13. Site details revised at 12 of 187 sitesv46
  14. Study sites revised (187)v45 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 185 to 187v44
  16. Site details revised at 2 of 185 sitesv43
  17. Study sites: 184 to 185v42
  18. Study sites: 183 to 184v41
  19. Phase: Phase 2 to Phase 2/3 Primary and study completion dates: May 2028 to Apr 2029 · Enrollment target: 285 to 350 · Study sites: 180 to 183 · 2 morev40 Show 5 more changesShow less
    • Primary and study completion dates: May 2028 to Apr 2029
    • Enrollment target: 285 to 350
    • Study sites: 180 to 183
    • Eligibility criteria shortened, about 1,015 words
    • Secondary endpoints: 6 to 8

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 179 to 180v39
  21. Study sites: 168 to 179v38
  22. Study sites: 165 to 168v37
  23. Study sites: 163 to 165v36
  24. Study sites: 159 to 163v35
  25. Study sites: 156 to 159v34
  26. Study sites: 150 to 156v33
  27. Re-verified, no change to tracked fieldsv32
  28. Study sites: 147 to 150v31
  29. Study sites: 141 to 147v30
  30. Study sites: 139 to 141v29
  31. Study sites: 129 to 139v28
  32. Study sites: 128 to 129v27
  33. Study sites: 127 to 128v26
  34. Study sites: 115 to 127v25
  35. Study sites: 114 to 115v24
  36. Study sites: 109 to 114v23
  37. Study sites: 97 to 109v22
  38. Study sites: 88 to 97v21
  39. Study sites: 80 to 88v20
  40. Study sites: 78 to 80v19
  41. Study sites: 74 to 78v18
  42. Study sites: 69 to 74v17
  43. Primary and study completion dates: May 2025 to May 2028 Study sites: 62 to 69v16 Show 1 more changeShow less
    • Study sites: 62 to 69
  44. Study sites: 60 to 62v15
  45. Study sites: 59 to 60v14
  46. Study sites: 58 to 59v13
  47. Study sites: 55 to 58v12
  48. Study sites: 47 to 55v11
  49. Study sites: 43 to 47v10
  50. Study sites: 39 to 43v9
  • 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.
BioNTech SE
49 trials monitored
See 3 trials at risk
Head & Neck Cancer
2,060 trials monitored
See 120 trials at risk
An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, is an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, is a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab) within Part A. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial. Patients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months.
Trial Details
NCT Number NCT04534205
Lead Sponsor BioNTech SE
Conditions Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
Enrollment 358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov