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Anti-PD 1 Brain Collaboration + Radiotherapy Extension (ABC-X Study)

Study acronym: ABC-X
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
See other at-risk trials from Melanoma Institute Australia

Record History

  1. Primary completion pushed from Aug 2026 to Dec 2026 Eligibility criteria expanded, about 48 words · Secondary endpoints: details revised at 2 of 17 entries · Study description expanded, about 12 words · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: details revised at 2 of 17 entries
    • Study description expanded, about 12 words
    • Publications: details revised at 1 of 1 entry
  2. Study sites: 10 to 9v19
  3. Eligibility criteria shortened, about 98 words Secondary endpoints: details revised at 14 of 17 entries · Site details revised at 1 of 10 sitesv18 Show 2 more changesShow less
    • Secondary endpoints: details revised at 14 of 17 entries
    • Site details revised at 1 of 10 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Aug 2024 to Aug 2026 Study sites: 8 to 10 · Completion date: Aug 2025 to Aug 2029v17 Show 2 more changesShow less
    • Study sites: 8 to 10
    • Completion date: Aug 2025 to Aug 2029
  5. Primary completion date: Aug 2023 to Aug 2024v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date: Aug 2022 to Aug 2023v15
  2. Re-verified, no change to tracked fieldsv14
  3. Study sites: 6 to 8v13
  4. Study sites: 5 to 6v12
  5. Site details revised at 1 of 5 sitesv11
  6. Completion date: Aug 2024 to Aug 2025 Eligibility criteria expanded, about 67 words · Secondary endpoints: details revised at 2 of 17 entries · Study description revisedv10 Show 3 more changesShow less
    • Eligibility criteria expanded, about 67 words
    • Secondary endpoints: details revised at 2 of 17 entries
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 4 to 5 Study description shortened, about 100 wordsv9 Show 1 more changeShow less
    • Study description shortened, about 100 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study description expanded, about 5 wordsv8 See this version in full on ClinicalTrials.gov ↗
  9. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2019 to Aug 14, 2019 · Study description revised · Site details revised at 4 of 4 sitesv7 Show 3 more changesShow less
    • Start date changed from estimate of Aug 2019 to Aug 14, 2019
    • Study description revised
    • Site details revised at 4 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  10. Primary completion date: Jul 2022 to Aug 2022 Start date: Jul 2019 to Aug 2019 · Eligibility criteria expanded, about 46 words · Secondary endpoints: 14 to 17 · 2 morev6 Show 5 more changesShow less
    • Start date: Jul 2019 to Aug 2019
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: 14 to 17
    • Study description expanded, about 140 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 5 to 4 Primary completion date: Jun 2022 to Jul 2022 · Start date: Jun 2019 to Jul 2019 · Interventions: Ipilimumab (Drug), Nivolumab (Drug), Salvage Radiotherapy (Radiation), Stereotactic Radiotherapy (Radiation) to Ipilimumab (Drug), Nivolumab (Drug), Salvage therapy (Other), Stereotactic Radiotherapy (Radiation) · 2 morev5 Show 5 more changesShow less
    • Primary completion date: Jun 2022 to Jul 2022
    • Start date: Jun 2019 to Jul 2019
    • Interventions: Ipilimumab (Drug), Nivolumab (Drug), Salvage Radiotherapy (Radiation), Stereotactic Radiotherapy (Radiation) to Ipilimumab (Drug), Nivolumab (Drug), Salvage therapy (Other), Stereotactic Radiotherapy (Radiation)
    • Secondary endpoints revised (14)
    • Study description expanded, about 46 words

    See this version in full on ClinicalTrials.gov ↗

  12. Primary completion date: Aug 2020 to Jun 2022 Start date: Feb 2019 to Jun 2019 · Primary endpoint revised · Enrollment target: 155 to 218 · 8 morev4 Show 11 more changesShow less
    • Start date: Feb 2019 to Jun 2019
    • Primary endpoint revised
    • Enrollment target: 155 to 218
    • Completion date: Aug 2023 to Aug 2024
    • Interventions: Ipilimumab (Drug), Nivolumab (Drug), Stereotactic Radiotherapy (Radiation), Whole Brain Radiotherapy (Radiation) to Ipilimumab (Drug), Nivolumab (Drug), Salvage Radiotherapy (Radiation), Stereotactic Radiotherapy (Radiation)
    • Eligibility criteria shortened, about 52 words
    • Secondary endpoints: 15 to 14
    • Study description shortened, about 95 words
    • Site contacts updated at 5 of 5 sites
    • Study arms: 3 to 2
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  13. Start date: Aug 2018 to Feb 2019v3
  14. Start date: Feb 2018 to Aug 2018 Completion date: Feb 2023 to Aug 2023v2 Show 1 more changeShow less
    • Completion date: Feb 2023 to Aug 2023
  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 phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.
Trial Details
NCT Number NCT03340129
Lead Sponsor Melanoma Institute Australia
Collaborators: Bristol-Myers Squibb
Conditions Melanoma Stage Iv
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov