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Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV Melanoma

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Study completion pushed from Jan 2026 to Jun 2026v17
  2. Study completion date: Jul 31, 2025 to Jan 2026v16
  3. Study completion date: Jan 31, 2025 to Jul 31, 2025v15
  4. Study completion date: Jul 2024 to Jan 31, 2025v14
  5. 2 versions Re-verified since Feb 22, 2023, no change to tracked fieldsv12-v13
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  1. Lead sponsor: Maria Constantinou to Brown Universityv11 Show 9 more changesShow less
    • Results first posted: Mar 22, 2022
    • Primary endpoints revised (2)
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 25 to confirmed 22
    • Study completion date: Mar 2021 to Jul 2024
    • Site details revised
    • Collaborators: 3 to 2
    • Study title shortened, about 11 words
    • Study description expanded, about 3 words
  2. Site contact updatedv10
  3. Primary completion date: Mar 2018 to Mar 2019
    • Eligibility criteria expanded, about 25 words
    v9
  4. Lead sponsor: howard safran to Maria Constantinouv8
  5. Re-verified, no change to tracked fieldsv7
  6. Site contact updatedv6
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2016 to Jul 2016
    • Site details revised
    v5
  8. Eligibility criteria expanded, about 21 wordsv4
  9. Eligibility criteria shortened, about 24 wordsv3
  10. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Brown University
80 trials monitored
See 9 trials at risk
Melanoma
1,092 trials monitored
See 60 trials at risk
Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma. High dose interferon is a standard of care in the adjuvant setting but is highly toxic and marginally effective. The combination of ipilimumab and nivolumab is the most active regimen in patients with advanced melanoma so there is clear rationale to test this regimen in the adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be six months.
Trial Details
NCT Number NCT02656706
Lead Sponsor Brown University
Collaborators: Rhode Island Hospital, The Miriam Hospital
Conditions
(from sponsor)		 Melanoma
Related terms Melanoma
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov