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Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Dec 2025 to Dec 2026v17
  2. Completion date: Dec 2024 to Dec 2025v16
  3. Trial status: Suspended to Active, Not Recruiting Results first posted: Nov 27, 2024v15 Show 1 more changeShow less
    • Results first posted: Nov 27, 2024
  4. Enrollment target: estimated 27 to confirmed 14 Primary completion date: Mar 3, 2023 to Aug 8, 2023 · Completion date: May 2024 to Dec 2024 · Secondary endpoints revised (3) · 1 morev14 Show 4 more changesShow less
    • Primary completion date: Mar 3, 2023 to Aug 8, 2023
    • Completion date: May 2024 to Dec 2024
    • Secondary endpoints revised (3)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date changed from estimate of May 2023 to Mar 3, 2023v13
Show 11 earlier versionsHide 11 earlier versions
  1. Trial status: Recruiting to Suspended Sponsor's reason: futility stage with the first 14 subjects completed Site details revised at 3 of 3 sitesv12 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  2. Primary completion date: Mar 2022 to May 2023 Completion date: Mar 2023 to May 2024v11 Show 1 more changeShow less
    • Completion date: Mar 2023 to May 2024
  3. Site contacts updated at 2 of 3 sitesv10
  4. 2 versions Re-verified since Dec 3, 2020, no change to tracked fieldsv8-v9
  5. Eligibility criteria expanded, about 16 wordsv7 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 2 of 3 sitesv6
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Mar 2020 to Mar 2, 2020v5 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Mar 2020 to Mar 2, 2020
  8. Start date: Dec 2019 to Mar 2020v4
  9. Start date: Oct 2019 to Dec 2019v3
  10. Secondary endpoints: 4 to 3 Study title shortened, about 4 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Georgetown University
65 trials monitored
See 7 trials at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
In this phase II advanced melanoma study, all patients will receive treatment with nivolumab/ipilimumab plus cabozantinib for a 12 week induction period followed by nivolumab plus cabozantinib maintanence to complete up to 2 years of therapy unless disease progression, dose limiting toxicity, provider/patient decision or patient withdrawal of consent occurs. The primary endpoint is the one year PFS rate. Patients will have staging scans at baseline and every 12 weeks during the first 2 years on study. Safety evaluations including labs, EKG and history and physical will occur at each visit. Baseline tumor sample is required and on treatment biopsy will be optional of superficial tumor in the skin, subcutaneous tissue or lymph node that is palpable.
Trial Details
NCT Number NCT04091750
Lead Sponsor Georgetown University
Collaborators: MedStar Franklin Square Medical Center, Hackensack Meridian Health, Exelixis
Conditions Melanoma
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov