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Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

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

Record History

  1. Re-verified, no change to tracked fieldsv18
  2. Study sites: 51 to 38
    • Primary completion date changed from estimate of Nov 2023 to Oct 24, 2023
    • Study completion date: Feb 2024 to Jan 2027
    v17
  3. Primary completion date: Apr 2022 to Nov 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 270 to confirmed 271
    • Study sites: 43 to 51
    v16
  4. Study sites: 42 to 43v15
  5. Study sites: 41 to 42v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 40 to 41v13
  2. Study sites: 39 to 40v12
  3. Study sites: 29 to 39v11
  4. Study sites: 22 to 29v10
  5. Study sites: 8 to 22v9
  6. Re-verified, no change to tracked fieldsv8
  7. Study sites: 6 to 8v7
  8. Study sites: 2 to 6v6
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Aug 2018 to Oct 30, 2018
    v5
  10. Start date: Jul 2018 to Aug 2018v4
  11. Start date: Feb 2018 to Jul 2018v3
  12. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Trial Details
NCT Number NCT03235245
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Conditions
(from sponsor)		 Unresectable Stage III Melanoma, Stage IV Melanoma
Related terms Melanoma
Enrollment 271 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov