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A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

StatusActive, Not Recruiting
PhasePhase 3
SponsorMerus B.V.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Trial sites reduced: 205 → 202 locations · Enrollment target: estimated 700 to confirmed 699 · Eligibility criteria expanded, about 30 words · 2 more Show 5 more changesShow less
    • Trial sites reduced: 205 → 202 locations
    • Enrollment target: estimated 700 to confirmed 699
    • Eligibility criteria expanded, about 30 words
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 202 → 205 locationsv25
  3. Trial sites expanded: 197 → 202 locationsv24
  4. Enrollment increased: 500 → 700 participants Trial sites expanded: 191 → 197 locations · Eligibility criteria shortened, about 8 words · Secondary endpoints: 14 to 16v23 Show 3 more changesShow less
    • Trial sites expanded: 191 → 197 locations
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 14 to 16

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 3 of 191 sitesv22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 185 to 191 Eligibility criteria revisedv21 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 179 to 185v20
  3. Study sites: 175 to 179v19
  4. Study sites: 167 to 175v18
  5. Study sites: 164 to 167v17
  6. Study sites: 158 to 164v16
  7. Study sites: 154 to 158v15
  8. Study sites: 144 to 154v14
  9. Study sites: 132 to 144v13
  10. Study sites: 129 to 132v12
  11. Study sites: 121 to 129v11
  12. Study sites: 115 to 121v10
  13. Study sites: 105 to 115v9
  14. Primary endpoints revised (2) Study sites: 102 to 105 · Eligibility criteria expanded, about 28 words · Secondary endpoints: 3 to 14 · 2 morev8 Show 5 more changesShow less
    • Study sites: 102 to 105
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 3 to 14
    • Study description expanded, about 1 word
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 77 to 102v7
  16. Study sites: 46 to 77v6
  17. Study sites: 30 to 46v5
  18. Study sites: 14 to 30v4
  19. Study sites: 2 to 14 Start date changed from estimate of Aug 2024 to Sep 25, 2024v3 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2024 to Sep 25, 2024
  20. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Interventions: Pembrolizumab (Drug), Petosemtamab + Pembrolizumab (Drug) to Pembrolizumab (Drug), Petosemtamab (Drug) · Secondary endpoints revised (3) · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Interventions: Pembrolizumab (Drug), Petosemtamab + Pembrolizumab (Drug) to Pembrolizumab (Drug), Petosemtamab (Drug)
    • Secondary endpoints revised (3)
    • Study title shortened, about 7 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.
Merus B.V.
5 trials monitored
See 1 trial at risk
Head & Neck Cancer
2,060 trials monitored
See 120 trials at risk
This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.
Trial Details
NCT Number NCT06525220
Lead Sponsor Merus B.V.
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 699 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov