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Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma

Study acronym: I-MAT
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion moved earlier from Apr 1, 2027 to Nov 10, 2026 Eligibility criteria expanded, about 31 words · Secondary endpoints: details revised at 4 of 6 entries · Site details revised at 2 of 20 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 2 of 20 sites
  2. Primary completion date: Apr 30, 2027 to Apr 1, 2027v24
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 120 to confirmed 122 · Site details revised at 20 of 20 sitesv23 Show 2 more changesShow less
    • Enrollment target: estimated 120 to confirmed 122
    • Site details revised at 20 of 20 sites
  4. Enrollment target: 132 to 120 Study sites: 19 to 20 · Primary completion date: Apr 1, 2027 to Apr 30, 2027 · Completion date: Apr 1, 2028 to Apr 30, 2030 · 1 morev22 Show 4 more changesShow less
    • Study sites: 19 to 20
    • Primary completion date: Apr 1, 2027 to Apr 30, 2027
    • Completion date: Apr 1, 2028 to Apr 30, 2030
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Dec 2025 to Apr 1, 2027 Completion date: Dec 2028 to Apr 1, 2028 · Start date: Oct 8, 2020 to Oct 26, 2020 · Site contacts updated at 1 of 19 sitesv21 Show 3 more changesShow less
    • Completion date: Dec 2028 to Apr 1, 2028
    • Start date: Oct 8, 2020 to Oct 26, 2020
    • Site contacts updated at 1 of 19 sites
Show 19 earlier versionsHide 19 earlier versions
  1. Site details revised at 1 of 19 sitesv20
  2. Study sites: 18 to 19v19
  3. Study description shortened, about 3 wordsv18 See this version in full on ClinicalTrials.gov ↗
  4. Eligibility criteria shortened, about 4 wordsv17 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 4 of 18 sitesv16
  6. Study sites: 13 to 18v15
  7. Study sites: 12 to 13v14
  8. Site details revised at 1 of 12 sitesv13
  9. Eligibility criteria revised Secondary endpoints: details revised at 2 of 6 entries · Study description shortened, about 11 words · Site details revised at 1 of 12 sitesv12 Show 3 more changesShow less
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description shortened, about 11 words
    • Site details revised at 1 of 12 sites

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv11
  11. Site details revised at 1 of 12 sitesv10
  12. Start date changed from estimate of Oct 2020 to Oct 8, 2020 Study sites revised (12)v9 Show 1 more changeShow less
    • Study sites revised (12)

    See this version in full on ClinicalTrials.gov ↗

  13. Site details revised at 3 of 12 sitesv8
  14. Site details revised at 1 of 12 sitesv7
  15. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2020 to Oct 2020 · Site details revised at 12 of 12 sitesv6 Show 2 more changesShow less
    • Start date: Sep 2020 to Oct 2020
    • Site details revised at 12 of 12 sites
  16. Eligibility criteria expanded, about 9 words Study sites revised (12) · Study title expanded, about 7 wordsv5 Show 2 more changesShow less
    • Study sites revised (12)
    • Study title expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  17. Study sites: 8 to 12v4
  18. Start date: May 2020 to Sep 2020 Study sites: 1 to 8v3 Show 1 more changeShow less
    • Study sites: 1 to 8
  19. Re-verified, no change to tracked fieldsv2
  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.
The I-MAT trial is a randomised, placebo-controlled, phase II trial of adjuvant Avelumab in patients with stage I-III Merkel cell carcinoma aiming to explore the efficacy of avelumab as adjuvant immunotherapy.
Trial Details
NCT Number NCT04291885
Lead Sponsor Melanoma and Skin Cancer Trials Limited
Conditions Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage I, Merkel Cell Carcinoma, Stage II, Merkel Cell Carcinoma, Stage III, Neuroendocrine Tumors, Carcinoma Neuroendocrine Skin
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov