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Avelumab Program Rollover Study

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 21, 2026 → Nov 24, 2026
See other at-risk trials from Merck KGaA

Record History

  1. Lead sponsor: EMD Serono Research & Development Institute, Inc. to EMD Serono Research & Development Institute, Inc. Primary and study completion pushed from Aug 21, 2026 to Nov 24, 2026 · Eligibility criteria expanded, about 11 words · Site details revised at 23 of 104 sites Show 3 more changesShow less
    • Primary and study completion pushed from Aug 21, 2026 to Nov 24, 2026
    • Eligibility criteria expanded, about 11 words
    • Site details revised at 23 of 104 sites
  2. Re-verified, no change to tracked fieldsv46
  3. Primary and study completion dates: Feb 19, 2027 to Aug 21, 2026v45
  4. Primary and study completion dates: Feb 20, 2026 to Feb 19, 2027 Study sites: 103 to 104v44 Show 1 more changeShow less
    • Study sites: 103 to 104
  5. 3 versions Re-verified since Feb 5, 2025, no change to tracked fieldsv41-v43
Show 39 earlier versionsHide 39 earlier versions
  1. Primary and study completion dates: Nov 1, 2024 to Feb 20, 2026v40
  2. 2 versions Re-verified since Aug 21, 2024, no change to tracked fieldsv38-v39
  3. Enrollment target: 161 to 205v37
  4. Primary and study completion dates: Jan 28, 2024 to Nov 1, 2024 Study sites: 75 to 103v36 Show 1 more changeShow less
    • Study sites: 75 to 103
  5. 3 versions Re-verified since May 3, 2023, no change to tracked fieldsv33-v35
  6. Study sites: 22 to 75v32
  7. 4 versions Re-verified since Sep 20, 2021, no change to tracked fieldsv28-v31
  8. Trial status: Recruiting to Active, Not Recruiting Study sites: 17 to 22v27 Show 1 more changeShow less
    • Study sites: 17 to 22
  9. 6 versions Re-verified since Dec 15, 2020, no change to tracked fieldsv21-v26
  10. Enrollment target: 151 to 161v20
  11. 2 versions Re-verified since Sep 21, 2020, no change to tracked fieldsv18-v19
  12. Enrollment target: 150 to 151v17
  13. Enrollment target: 137 to 150v16
  14. Enrollment target: 264 to 137v15
  15. 4 versions Re-verified since Dec 9, 2019, no change to tracked fieldsv11-v14
  16. Study sites: 18 to 17v10
  17. Study sites: 19 to 18v9
  18. 2 versions Re-verified since Aug 20, 2019, no change to tracked fieldsv7-v8
  19. Study sites: 2 to 19v6
  20. Re-verified, no change to tracked fieldsv5
  21. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 28, 2019 to Mar 22, 2019 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 28, 2019 to Mar 22, 2019
    • Site details revised at 2 of 2 sites
  22. Start date: Mar 12, 2019 to Mar 28, 2019v3
  23. Start date: Jan 31, 2019 to Mar 12, 2019v2
  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.
Merck KGaA
43 trials monitored
See 4 trials at risk
The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
Trial Details
NCT Number NCT03815643
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Solid Tumors
Enrollment 205 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov