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A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)

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

Record History

  1. Trial sites reduced: 197 → 194 locations Trial sites reduced: 208 → 197 locations Show 1 more changeShow less
    • Trial sites reduced: 208 → 197 locations
  2. Study sites: 208 to 197 Interventions: Investigator's Choice (Drug), Investigator's Choice (Drug), Investigator's Choice (Drug), Petosemtamab (Drug) to Investigator's Choice (Drug), Investigator's Choice (Drug), Investigator's Choice (Drug), Petosemtamab (Drug) · Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 4 of 15 entries · 1 more Show 4 more changesShow less
    • Interventions: Investigator's Choice (Drug), Investigator's Choice (Drug), Investigator's Choice (Drug), Petosemtamab (Drug) to Investigator's Choice (Drug), Investigator's Choice (Drug), Investigator's Choice (Drug), Petosemtamab (Drug)
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 4 of 15 entries
    • Publications: details revised at 1 of 1 entry
  3. Enrollment closed, study ongoing Trial sites reduced: 218 → 208 locations · Enrollment target: estimated 600 to confirmed 621 · Eligibility criteria shortened, about 27 words · 1 morev40 Show 4 more changesShow less
    • Trial sites reduced: 218 → 208 locations
    • Enrollment target: estimated 600 to confirmed 621
    • Eligibility criteria shortened, about 27 words
    • Secondary endpoints: 21 to 15

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 216 to 218v39
  5. Study sites: 214 to 216v38
  6. Primary endpoint(s) modified Enrollment increased: 500 → 600 participants · Trial sites expanded: 208 → 214 locations · Eligibility criteria shortened, about 14 words · 2 morev37 Show 5 more changesShow less
    • Enrollment increased: 500 → 600 participants
    • Trial sites expanded: 208 → 214 locations
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 18 to 21
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 207 to 208v36
  8. Study sites: 206 to 207v35
  9. Study sites: 202 to 206v34
  10. Study sites: 197 to 202v33
  11. Study sites: 193 to 197v32
  12. Study sites: 191 to 193v31
  13. Study sites: 186 to 191v30
  14. Study sites: 180 to 186v29
  15. Study sites: 174 to 180v28
  16. Study sites: 172 to 174v27
  17. Study sites: 170 to 172v26
  18. Study sites: 166 to 170v25
  19. Study sites: 163 to 166v24
  20. Study sites: 161 to 163v23
  21. Study sites: 160 to 161v22
  22. Study sites: 154 to 160v21
  23. Study sites: 150 to 154v20
  24. Study sites: 143 to 150v19
  25. Study sites: 137 to 143v18
  26. Study sites: 129 to 137v17
  27. Study sites: 116 to 129v16
  28. Study sites: 93 to 116v15
  29. Study sites: 85 to 93v14
  30. Study sites: 71 to 85v13
  31. Study sites: 53 to 71v12
  32. Study sites: 52 to 53v11
  33. Study sites: 45 to 52v10
  34. Study sites: 37 to 45v9
  35. Study sites: 30 to 37v8
  36. Study sites: 24 to 30v7
  37. Study sites: 18 to 24v6
  38. Study sites: 12 to 18v5
  39. Study sites: 8 to 12v4
  40. Study sites: 7 to 8v3
  41. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7 · Start date changed from estimate of Jul 2024 to Jun 25, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 7
    • Start date changed from estimate of Jul 2024 to Jun 25, 2024
  42. 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 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
Trial Details
NCT Number NCT06496178
Lead Sponsor Merus B.V.
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 621 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov