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Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Study completion date changed from estimate of Jul 10, 2026 to Jun 23, 2026 · Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 4 of 6 entries · 1 more Show 4 more changesShow less
    • Study completion date changed from estimate of Jul 10, 2026 to Jun 23, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 3 of 91 sites
  2. Results first posted: Mar 27, 2026 Primary endpoint revised · Secondary endpoints: 5 to 6v42 Show 2 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  3. Study Status, Referencesv41
  4. Completion date: Jun 30, 2025 to Jul 10, 2026v40
  5. 2 versions Re-verified since Apr 21, 2025, no change to tracked fieldsv38-v39
Show 36 earlier versionsHide 36 earlier versions
  1. Primary completion date changed from estimate of Feb 4, 2025 to Mar 14, 2025v37
  2. Re-verified, no change to tracked fieldsv36
  3. Primary completion date: May 21, 2024 to Feb 4, 2025 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 162 to confirmed 176 · Completion date: Sep 15, 2024 to Jun 30, 2025 · 1 morev35 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 162 to confirmed 176
    • Completion date: Sep 15, 2024 to Jun 30, 2025
    • Site details revised at 91 of 91 sites
  4. Re-verified, no change to tracked fieldsv34
  5. Site details revised at 1 of 91 sitesv33
  6. Site details revised at 1 of 91 sitesv32
  7. Site details revised at 1 of 91 sitesv31
  8. Site details revised at 1 of 91 sitesv30
  9. Study Status, Contacts/Locationsv29
  10. Site details revised at 2 of 91 sitesv28
  11. Study sites: 88 to 91v27
  12. Site details revised at 1 of 88 sitesv26
  13. Site details revised at 4 of 88 sitesv25
  14. Site details revised at 4 of 88 sitesv24
  15. Site details revised at 1 of 88 sitesv23
  16. Site details revised at 6 of 88 sitesv22
  17. Study sites revised (88)v21 See this version in full on ClinicalTrials.gov ↗
  18. Site details revised at 1 of 88 sitesv20
  19. Site details revised at 7 of 88 sitesv19
  20. Site details revised at 4 of 88 sitesv18
  21. Primary completion date: Jul 6, 2024 to May 21, 2024 Site details revised at 30 of 88 sitesv17 Show 1 more changeShow less
    • Site details revised at 30 of 88 sites
  22. Study sites: 86 to 88v16
  23. Study sites: 85 to 86v15
  24. Study sites: 83 to 85 Primary completion date: May 18, 2024 to Jul 6, 2024v14 Show 1 more changeShow less
    • Primary completion date: May 18, 2024 to Jul 6, 2024
  25. Start date changed from estimate of Oct 31, 2022 to Nov 14, 2022 Site details revised at 1 of 83 sitesv13 Show 1 more changeShow less
    • Site details revised at 1 of 83 sites
  26. Study sites: 82 to 83v12
  27. Site details revised at 2 of 82 sitesv11
  28. Study sites: 80 to 82v10
  29. Study sites: 75 to 80v9
  30. Start date: Sep 26, 2022 to Oct 31, 2022 Site details revised at 5 of 75 sitesv8 Show 1 more changeShow less
    • Site details revised at 5 of 75 sites
  31. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 75 · Primary completion date: Apr 21, 2024 to May 18, 2024 · Completion date: Jun 20, 2024 to Sep 15, 2024 · 1 morev7 Show 4 more changesShow less
    • Study sites: 0 to 75
    • Primary completion date: Apr 21, 2024 to May 18, 2024
    • Completion date: Jun 20, 2024 to Sep 15, 2024
    • Start date: Sep 30, 2022 to Sep 26, 2022
  32. Start date: Aug 30, 2022 to Sep 30, 2022v6
  33. Start date: Jul 22, 2022 to Aug 30, 2022 Primary completion date: Jan 22, 2024 to Apr 21, 2024 · Completion date: May 21, 2024 to Jun 20, 2024v5 Show 2 more changesShow less
    • Primary completion date: Jan 22, 2024 to Apr 21, 2024
    • Completion date: May 21, 2024 to Jun 20, 2024
  34. Start date: Jun 1, 2022 to Jul 22, 2022v4
  35. Re-verified, no change to tracked fieldsv3
  36. Start date: Apr 29, 2022 to Jun 1, 2022 Primary completion date: Jan 30, 2024 to Jan 22, 2024 · Completion date: May 30, 2025 to May 21, 2024 · Eligibility criteria revised · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Jan 30, 2024 to Jan 22, 2024
    • Completion date: May 30, 2025 to May 21, 2024
    • Eligibility criteria revised
    • Study title expanded, about 4 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.
Incyte
94 trials monitored
See 9 trials at risk
Head & Neck Cancer
2,060 trials monitored
See 120 trials at risk
The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
Trial Details
NCT Number NCT05287113
Lead Sponsor Incyte Biosciences International Sàrl
Conditions Head and Neck Cancer
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov